SEC Connect

0001654954-16-004120.txt : 20161116 0001654954-16-004120.hdr.sgml : 20161116 20161116142656 ACCESSION NUMBER: 0001654954-16-004120 CONFORMED SUBMISSION TYPE: 10-Q PUBLIC DOCUMENT COUNT: 61 CONFORMED PERIOD OF REPORT: 20160930 FILED AS OF DATE: 20161116 DATE AS OF CHANGE: 20161116 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Echo Therapeutics, Inc. CENTRAL INDEX KEY: 0001031927 STANDARD INDUSTRIAL CLASSIFICATION: ELECTROMEDICAL & ELECTROTHERAPEUTIC APPARATUS [3845] IRS NUMBER: 411649949 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 10-Q SEC ACT: 1934 Act SEC FILE NUMBER: 001-35218 FILM NUMBER: 162002091 BUSINESS ADDRESS: STREET 1: 99 WOOD AVENUE SOUTH STREET 2: SUITE 302 CITY: ISELIN STATE: NJ ZIP: 08830 BUSINESS PHONE: 732-549-0919 MAIL ADDRESS: STREET 1: 99 WOOD AVENUE SOUTH STREET 2: SUITE 302 CITY: ISELIN STATE: NJ ZIP: 08830 FORMER COMPANY: FORMER CONFORMED NAME: SONTRA MEDICAL CORP DATE OF NAME CHANGE: 20020702 FORMER COMPANY: FORMER CONFORMED NAME: CHOICETEL COMMUNICATIONS INC/MN/ DATE OF NAME CHANGE: 20020701 FORMER COMPANY: FORMER CONFORMED NAME: SONTRA MEDICAL CORP DATE OF NAME CHANGE: 20020701 10-Q 1 ecte10q_sep302016.htm FORM 10-Q SEC Connect

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 20549

________________

FORM 10-Q

________________

☑ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended September 30, 2016

☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from _________ to __________

Commission File Number: 000-35218

ECHO THERAPEUTICS, INC.

(Exact name of registrant as specified in its charter)

________________

Delaware	41-1649949
(State or other jurisdiction of incorporation or organization)	(I.R.S. Employer Identification Number)

99 Wood Avenue South, Suite 302, Iselin, NJ	08830
(Address of principal executive offices)	(Zip Code)

732-201-4194

(Registrant’s telephone number, including area code)

________________

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☑ No ☐

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). Yes ☑ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer,” and “smaller reporting company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer ☐

Accelerated filer ☐

Non-accelerated filer ☐ (Do not check if a smaller reporting company)

Smaller reporting company ☑

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☑

As of October 30, 2016, 12,004,308 shares of the registrant’s Common Stock, $0.01 par value, were issued and outstanding.

ECHO THERAPEUTICS, INC.

QUARTERLY REPORT ON FORM 10-Q

FOR THE QUARTER ENDED

SEPTEMBER 30, 2016

TABLE OF CONTENTS



Item
PART I - FINANCIAL INFORMATION

1.	Condensed Consolidated Financial Statements (Unaudited):
	Condensed Consolidated Balance Sheets as of September 30, 2016 and December 31, 2015	1
	Condensed Consolidated Statements of Operations for the three and nine months ended September 30, 2016 and 2015	2
	Condensed Consolidated Statement of Changes in Stockholders’ Deficit for the nine months ended September 30, 2016	3
	Condensed Consolidated Statements of Cash Flows for the nine months ended September 30, 2016 and 2015	4
	Notes to Condensed Consolidated Financial Statements	5
2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	13
3.	Quantitative and Qualitative Disclosures About Market Risk	17
4.	Controls and Procedures	17

PART II - OTHER INFORMATION

6.	Exhibits	17

SIGNATURES		18
EXHIBIT INDEX		19

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PART I—FINANCIAL INFORMATION

ITEM 1. FINANCIAL STATEMENTS.

ECHO THERAPEUTICS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(Unaudited)

	September 30,	December 31,
	2016	2015
ASSETS

Current assets:
Cash and cash equivalents	$172,725	$56,210
Prepaid and other	229,229	244,534
Total current assets	401,954	300,744

Property and equipment, net	188,936	267,671

Other assets:
Cash restricted pursuant to letters of credit	217,556	236,425
Capitalized software development costs	267,811	—
Other	250	250
Total other assets	485,617	236,675
Total assets	$1,076,507	$805,090

LIABILITIES AND STOCKHOLDERS’ DEFICIT

Current liabilities:
Accounts payable	$1,851,043	$2,176,083
Accrued and other	884,253	602,345
Secured convertible notes, net	3,248,731	—
Bridge loans	250,000	330,000
Premium financing	22,638	—
Derivative liabilities	1,010,694	127,000
Total current liabilities	7,267,359	3,235,428
Deferred revenue, net	95,535	95,535
Total liabilities	7,362,894	3,330,963

Commitments and contingencies

Stockholders’ deficit:
Preferred Stock, $0.01 par value; 40,000,000 shares authorized:
Convertible Series
C - 10,000 shares authorized;1,000 issued and outstanding	10	10
D - 3,600,000 shares authorized;1,000,000 issued and outstanding	10,000	10,000
E - 1,748,613 shares authorized; issued and outstanding	17,486	17,486
F - 6,000,000 shares authorized; 5,276,180 issued and outstanding	52,762	52,762
Common stock, $0.01 par value; 150,000,000 shares authorized; issued and outstanding 11,635,915 and 11,124,496 shares, respectively
Common stock, $0.01 par value; 150,000,000 shares authorized; issued and outstanding 11,635,915 and 11,124,496 shares, respectively	116,358	111,243
Additional paid-in capital	148,414,835	147,412,559
Accumulated deficit	(154,897,838)	(150,129,933)
Total stockholders’ deficit	(6,286,387)	(2,525,873)
Total liabilities and stockholders’ deficit	$1,076,507	$805,090

See accompanying notes to the condensed consolidated financial statements.

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ECHO THERAPEUTICS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited)

	For the Three Months Ended September 30,		For the Nine Months Ended September 30,
	2016	2015	2016	2015

Licensing revenue	$—	$—	$—	$—
Total revenues	—	—	—	—

Operating expenses:
Research and development	588,551	558,995	1,943,287	2,027,896
Selling, general and administrative	1,198,328	820,662	2,927,716	3,815,746
Impairment charge	—	—	—	9,625,000
Loss (gain) on disposal of property and equipment	—	39,382	(4,000)	278,816
Depreciation and amortization	26,925	39,171	85,090	487,491
Total operating expenses	1,813,804	1,458,210	4,952,093	16,234,949

Loss from operations	(1,813,804)	(1,458,210)	(4,952,093)	(16,234,949)

Other income (expense):
Gain (loss) on revaluation of derivative liabilities	3,675,826	(54,000)	4,437,776	(61,845)
Financing loss	—	(263,000)	—	(4,620,000)
Loss on early extinguishment of bridge loans	—	—	(2,143,960)	—
Amortization of debt discount	(934,794)	—	(1,830,012)	—
Interest expense	(133,057)	(212)	(279,616)	(4,938)
Other income (expense), net	2,607,975	(317,212)	184,188	(4,686,783)
Net income (loss)	$794,171	$(1,775,422)	$(4,767,905)	$(20,921,732)
Deemed dividend on beneficial conversion feature of preferred stock	—	—	(6,460,818)	—
Net income (loss) applicable to common shareholders	$794,171	$(1,775,422)	$(11,228,723)	$( 20,921,732)

Net loss per common share, basic	$0.07	$(0.16)	$(0.98)	$(1.86)
Net loss per common share, diluted	$(0.11)	$(0.16)	$(0.98)	$(1.86)

Basic weighted average common shares outstanding	11,603,868	11,127,475	11,418,653	11,266,571
Diluted weighted average common shares outstanding	17,261,692	11,127,475	11,418,653	11,266,571

See accompanying notes to the condensed consolidated financial statements.

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ECHO THERAPEUTICS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ DEFICIT

FOR THE NINE MONTHS ENDED SEPTEMBER 30, 2016 (Unaudited)

	Preferred Stock		Common Stock		Additional Paid-in	Accumulated	Total Stockholders'
	Shares	Amount	Shares	Amount	Capital	Deficit	Deficit

Balance at December 31, 2015	8,025,793	$80,258	11,124,496	$111,243	$147,412,559	$(150,129,933)	$(2,525,873)
Share-based compensation, net of restricted stock cancellations	—	—	275,695	2,757	700,106	—	702,863
Exercise of stock options	—	—	2,246	23	(23)	—	—
Settlement of account payable	—	—	57,121	571	93,079	—	93,650
Payment of interest	—	—	101,357	1,014	130,614	—	131,628
Payment of investor relations	—	—	75,000	750	78,500	—	79,250
Net loss	—	—	—	—	—	(4,767,905)	(4,767,905)
Balance at September 30, 2016	8,025,793	$80,258	11,635,915	$116,358	$148,414,835	$(154,897,838)	$(6,286,387)

See accompanying notes to the condensed consolidated financial statements.

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ECHO THERAPEUTICS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited)

	For the Nine Months Ended September 30,
	2016	2015
Cash Flows From Operating Activities:
Net loss	$(4,767,905)	$(20,921,732)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization	85,090	487,491
Amortization of debt discount	1,830,012	—
Share-based compensation, net	702,863	798,250
Loss on early extinguishment of bridge loans	2,143,960	—
(Gain) loss on revaluation of derivative liabilities	(4,437,776)	61,845
Warrant repricing charged to legal expense	—	328,000
(Gain) Loss on disposal of assets	(4,000)	278,816
Impairment charge	—	9,625,000
Financing loss	—	4,620,000
Changes in assets and liabilities:
Prepaid and other	15,318	(4,853)
Accounts payable	(152,154)	395,973
Accrued and other	417,156	(100,836)
Net cash used in operating activities	(4,167,436)	(4,432,046)
Cash Flows from Investing Activities:
Purchase of property and equipment	(6,354)	(55,836)
Decrease in restricted cash	18,869	(183,938)
Capitalization of software development costs	(267,811)	—
Proceeds on disposal of property and equipment	4,000	126,082
Net cash used in investing activities	(251,296)	(113,692)
Cash Flows From Financing Activities:
Proceeds from secured convertible notes, net of related costs	2,512,609	—
Proceeds from bridge loans	2,000,000	—
Proceeds from equity financing	—	3,181,500
Proceeds from premium financing	199,671	272,622
Principal payments from premium financing	(177,033)	(243,420)
Capital contribution	—	59,325
Net cash provided by financing activities	4,535,247	3,270,027
Net increase in cash and cash equivalents	116,515	(1,275,711)
Cash and cash equivalents:
Beginning of period	56,210	1,278,941
End of period	$172,725	$3,230
Supplemental disclosure of cash flow information:
Cash paid during the year:
Interest	$15,709	$5,043
Income taxes	$2,761	$—
Supplemental disclosure of non-cash financing transactions:
Deemed dividend on beneficial conversion feature of convertible preferred stock	$6,460,818	$—
Directors fees payable offset against prepaid insurance	$—	$272,200
Security deposit offset against accounts payable	$—	$9,740
Accrued legal fees settled with stock	$—	$550,000
Accrued interest settled with stock	$131,628	$—
Account payable settled with stock	$172,900	$—
Bridge loans exchanged for secured convertible notes	$2,080,000	$—
Derivatives offset against secured convertible notes	$5,321,470	$—
Conversion of convertible preferred stock into common stock at par value	$—	$15,000
Subscriptions receivable for Series F Preferred Stock	$—	$300,000

See accompanying notes to the condensed consolidated financial statements.

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Echo Therapeutics, Inc.

Notes to Condensed Consolidated Financial Statements

(Unaudited)

(1) ORGANIZATION AND BASIS OF PRESENTATION

Echo Therapeutics, Inc. (the "Company") is a medical device company with expertise in advanced skin permeation technology. The Company is developing its non-invasive, wireless continuous glucose monitoring (CGM) system with potential use in the outpatient diabetes market. A significant opportunity may also exist in the wearable-health consumer market and in the hospital setting. Echo has also developed its needle-free skin preparation device as a platform technology that allows for enhanced skin permeation enabling extraction of analytes, such as glucose, enhanced delivery of topical pharmaceuticals and other applications.

The accompanying unaudited condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiary, Sontra Medical, Inc., a Delaware corporation. All significant intercompany balances and transactions have been eliminated in consolidation. These financial statements have been prepared in conformity with generally accepted accounting principles (“GAAP”) in the United States consistent with those applied in, and should be read in conjunction with, the Company’s audited consolidated financial statements and related footnotes for the year ended December 31, 2015 included in the Company’s Annual Report on Form 10-K as filed with the United States Securities and Exchange Commission (“SEC”) on March 30, 2016. These financial statements reflect all adjustments, consisting only of normal recurring adjustments, which are, in the opinion of management, necessary for a fair presentation of the Company’s financial position as of September 30, 2016 and its results of operations and cash flows for the interim periods presented and are not necessarily indicative of results for subsequent interim periods or for the full year. These interim financial statements do not include all of the information and footnotes required by GAAP for complete financial statements as allowed by the relevant SEC rules and regulations; however, the Company believes that its disclosures are adequate to ensure that the information presented is not misleading. Certain amounts in prior periods have been reclassified to conform to the current presentation.

(2) LIQUIDITY AND MANAGEMENT’S PLANS

The accompanying financial statements have been prepared on a basis that assumes that the Company will continue as a going concern and that contemplates the continuity of operations, the realization of assets and the satisfaction of liabilities and commitments in the normal course of business. As of September 30, 2016, the Company had cash of $172,725, working capital deficit of ($6,865,405) and an accumulated deficit of ($154,897,838). The Company continues to incur recurring losses from operations. The Company’s losses have resulted principally from costs incurred in connection with its research and development activities and from general and administrative costs associated with its operations. The Company also expects to have negative cash flows for the foreseeable future as it funds its operational losses and capital expenditures. This will result in decreases in the Company’s working capital, total assets and stockholders’ equity, which may not be offset by future funding. The Company will need to secure additional capital to fund its product development, research, manufacturing and clinical programs in accordance with its current planned operations. The Company has funded its operations in the past primarily through debt and equity issuances. Management will continue to pursue financing to fund its operations. No assurances can be given that additional capital will be available on terms acceptable to the Company. The accompanying financial statements do not include any adjustments that might result from the outcome of the uncertainty.

(3) PROPERTY AND EQUIPMENT

The principal categories and estimated useful lives of property and equipment were:

	09/30/16	12/31/15	Estimated Useful Lives
Computer equipment	$335,298	$332,764	3
Office and laboratory equipment	603,226	628,726	3-5
Furniture and fixtures	228,099	228,099	7
Manufacturing equipment	65,819	61,998	5
Leasehold improvements	41,968	41,968	3-7
Total property and equipment	1,274,410	1,293,555
Less accumulated depreciation and amortization	1,085,474	1,025,884
Property and equipment, net	$188,936	$267,671

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(4) CAPITALIZED SOFTWARE DEVELOPMENT COSTS

Software development costs associated with the planning and designing phase of software development, including coding and testing activities necessary to establish technological feasibility, are expensed as incurred. Once technological feasibility has been determined, a portion of the costs incurred in development, including coding, testing, and quality assurance, are capitalized. $25,170 and $267,811 of costs associated with the application programming of the Company’s smartphone application for its CGM were capitalized in the quarter and nine months ended September 30, 2016, respectively.

(5) FINANCING TRANSACTIONS

On January 29, 2016, the Company entered into a securities purchase agreement (the “Purchase Agreement”) with certain institutional and other accredited investors (the “Investors”) pursuant to which the Company agreed to issue up to $5,148,620 principal amount of 10% senior secured convertible notes of the Company (the “Notes”) and related common stock purchase warrants (the “Warrants”) in two tranches. The Notes are secured by substantially all of the assets of the Company pursuant to a Security Agreement, dated January 29, 2016 (the “Security Agreement”). The initial closing of $1,787,000 occurred on January 29, 2016. The second tranche of the financing, or $3,361,620, was subject to the Company obtaining shareholder approval which occurred on April 14, 2016. The Notes and Warrants are subject to customary antidilution provisions. With stockholder approval, the conversion price for the Notes is subject to a reset to eighty percent (80%) of the average of the ten lowest closing prices of the Common Stock less than $1.50 , subject to equitable adjustment, if any, as reported by Bloomberg LP for the principal market on which the Common Stock then trades during the ninety (90) days following the first effective date of a registration statement filed pursuant to the Registration Rights Agreement, but in no event less than $.80, subject to equitable adjustment. For the first closing, bridge notes in the principal amount of $680,000 were surrendered to the Company as payment by certain Investors. This was inclusive of $330,000 of bridge notes outstanding at December 31, 2015 and a $350,000 of promissory notes received at various dates in January 2016 from Beijing Yi Tang Bio Science & Technology, Ltd. (BYT). The Company recorded a loss on early extinguishment of these bridge loans of $415,725, representing the excess value of the consideration consisting of the $680,000 secured convertible note, and a proportional amount of the Warrants totaling $320,761 and the embedded conversion feature of the Notes totaling $94,964, exchanged for certain bridge loans to cancel them. Fees aggregating $368,080 were paid to the placement agent and others. The Notes issued in the first closing are initially convertible into 1,191,333 shares of common stock, par value $.01 per share, of the Company (the “Common Stock”), at $1.50 per share. In connection with the initial closing, the Company issued five-year Class A warrants to purchase 1,274,280 shares of Common Stock, inclusive of Class A warrants to purchase 82,947 share of Common Stock issued to the placement agent, at an exercise price of $1.50 per share, which are not exercisable for six months. These Warrants, whose exercise price is subject to adjustments should the Company consummate a future financing at a price less than $1.50, are considered a derivative. The initial value of these derivative warrants was $901,631 which was determined utilizing a Monte Carlo Binomial Model. The assumptions utilized for these derivative warrants, as well as embedded conversion feature, described hereafter, are disclosed in Note 10. Additionally the Notes contain an embedded conversion feature which adjusts the conversion price should the Company have a price reset during the ninety days after April 29, 2016 (the effective date of the Company’s registration) or consummate a future financing at a price less than $1.50, and is also considered a derivative. A price reset to $0.91 occurred on July 29, 2016 as is further described below. The initial value of the embedded conversion feature within the Notes was $249,559 which was also determined utilizing a Monte Carlo Binomial Model.

On February 4, 2016, the Company issued a promissory note to BYT in the aggregate principal amount of $300,000 in respect of a bridge loan made by such party. On February 11, 2016, the Company issued a promissory note to Platinum Partners Value Arbitrage Fund L.P. (“PPVA”) in the aggregate principal amount of $100,000 in respect of a bridge loan made by such party. On March 21, 2016, the Company issued a promissory note to PPVA in the aggregate principal amount of $150,000 in respect of a bridge loan made by such party. On April 4, 2016, the Company issued a promissory note to PPVA in the aggregate principal amount of $350,000 in respect of a bridge loan made by such party. On April 18, 2016, the Company issued a promissory note to PPVA in the aggregate principal amount of $450,000 in respect of a bridge loan made by such party. On April 29, 2016, the Company issued a promissory note to BYT in the aggregate principal amount of $50,000 in respect of a bridge loan made by such party. These promissory notes, aggregating $1,400,000, which bore interest at the prime rate (or 3.5%), were exchanged for the May 3, 2016 second tranche financing of the Notes described below.

On April 14, 2016, the Company held a Special Meeting of Stockholders. Of the 11,124,496 shares of common stock outstanding and entitled to vote, 6,197,024 shares, or 56%, were represented at the meeting in person or by proxy. The stockholders approved the issuance by the Company of shares of its Common Stock pursuant to and in accordance with the terms of the private placement financing transaction contemplated by the Securities Purchase Agreement, dated January 29, 2016, by and among the Company and the investors named therein, and the other documents and agreements related thereto, and the other transactions contemplated thereby, including the amendment to Company's Certificate of Designations governing the terms of its Series F Convertible Preferred Stock as described therein, for purposes of complying with applicable Delaware law and NASDAQ Listing Rule 5635(d), as disclosed in the Company’s proxy statement.

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On May 3, 2016, the Company closed the second tranche of the Note financing and issued Notes in an aggregate principal amount of $3,361,620, inclusive of $3,620 of interest due on bridge loans. In exchange for the Notes, the Company received $1,188,000 in gross cash proceeds, a note receivable, payable in 30 days and bearing interest at 12%, of $770,000, from BYT, and $1,400,000 of bridge notes were cancelled. The Company recorded a loss on early extinguishment of these bridge loans of $1,728,235, representing the excess value of the consideration consisting of the $1,400,000 secured convertible note, and a proportional amount of the Warrants totaling $510,348 and the embedded conversion feature of the Notes totaling $1,217,887, exchanged for certain bridge loans to cancel them. The Company incurred placement, legal and other fees aggregating $184,311 which were deducted from the gross cash proceeds. Additionally, the placement agent received Class B warrants, with a 1½ year term, to purchase 37,520 shares of the Company’s Common Stock at $1.50 per share. The Notes are initially convertible into 2,241,075 shares of Common Stock at $1.50 per share. The Company also issued Class B warrants, with a 1½ year term, to purchase 2,241,075 shares of Common Stock at $1.50 per share. The Company may call the Class B Warrants in the event that Company’s Common Stock is trading at 200% above the strike price for 10 consecutive trading days (at $100,000 value traded per day) if the Warrant is saleable into the public markets, provided that the holder will have the option of ten trading days to exercise. These Warrants, whose exercise price is subject to adjustments should the Company do a future financing at a price less than $1.50, are considered a derivative. The initial value of these derivative warrants was $1,245,943 which was determined utilizing a Monte Carlo Binomial Model. The assumptions utilized for these derivative warrants, as well as embedded conversion feature, described hereafter, are disclosed in Note 10. Additionally the Notes contain an embedded conversion feature which adjusts the conversion price should the Company have a price reset during the ninety days after April 29, 2016 (the effective date of the Company’s registration) or consummate a future financing at a price less than $1.50, and is also considered a derivative. A price reset to $0.91 occurred on July 29, 2016 as is further described below. The initial value of the embedded conversion feature within the Notes was $2,924,337 which was also determined utilizing a Monte Carlo Binomial Model.

In connection with the Note closing, the Certificate of Amendment to the Certificate of Designations of the Company’s Series F Convertible Preferred Stock was filed which provides the holders of 5,276,180 shares of the Company’s Series F Convertible Preferred Stock the same reset rights afforded the Note holders. This modification to the Series F provided them with a beneficial conversion feature. As a result of this change, the Company recorded a deemed dividend of $6,460,818.

Effective as of July 29, 2016, notice was given that the Conversion Price of the Notes issued to the note holders pursuant to the Securities Purchase Agreement, dated January 29, 2016 (the “Purchase Agreement”), between Echo Therapeutics, Inc. and the purchasers, had been reset from $1.50 per share to $0.91 per share. Additionally and also effective as of the same date, notice was given that, pursuant to Section 5(c)(v) of the Certification of Designation, Preferences and Rights of the Series F Convertible Preferred Stock of Echo Therapeutics, Inc. (the “Series F Designation”), the Conversion Ratio has been reset from 1:1 to 1:1.65. These resets were based on an amount equal to 80% of the average of the ten lowest closing prices of the Common Stock less than $1.50 per share during the ninety day period immediately following the effectiveness of the Registration Statement, as contemplated by Section 4(b) of the Notes. This price reset resulted in the Series F Convertible Preferred Stockholders receiving the right to 3,429,517 additional common shares upon conversion.

The Purchase Agreement for the above described Note financing contains customary representations, warranties and affirmative and negative covenants. The Purchase Agreement also requires management and certain shareholders to lock-up certain of their shares for the earlier of six months after the effective date of a registration statement, the first anniversary of the initial closing (January 29, 2017), or the date, if applicable, such holder of securities is no longer an officer or directors of the Company, subject to certain exceptions. In addition, for up to one year following the effective date of a registration statement, the Investors have the right to participate, on a pro rata basis, in certain subsequent financings by the Company, subject to certain limitations. In connection with the transaction, the Company entered into a registration rights agreement (the “Registration Rights Agreement”) that requires the Company to file one or more registration statements in respect of the shares of Common Stock underlying the Notes and Warrants. If the Company fails to make its filing deadlines or fails to maintain the registration statement for required periods of time, the Company will be subject to certain liquidated damages provisions. Newbridge Securities Corporation/Life Tech Capital (the “Placement Agent”) acted as the sole placement agent for the financing.

The Company may redeem the Notes at par when the Company stock price remains above $5.00 for ten consecutive days, or alternatively, at 125% of principal below $5.00. Interest is payable quarterly or, subject to receipt of stockholder approval, at the Company’s option, in shares of Common Stock.

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The assumptions utilized for the embedded conversion feature valuation, which reflect the initial valuation at January 29th, May 3rd and subsequent valuation at September 30, 2016, were as follows:

Risk-free interest rate %	0.34 – 0.48
Expected dividend yield	—
Expected term - years (contractual term)	0.33 – 0.59
Forfeiture rate	—
Expected volatility %	112
Timing of down-round triggering event	October 2016

Follows is a summary of the Notes and related discounts and the Loss on the early extinguishment of bridge loans:

	Original Value	Loss on Early Extinguishment of Bridge Loans	Secured Convertible Notes, net
Cash and other proceeds received from financing	—	—	$5,148,620
Warrants	$2,147,574	(831,109)	(1,316,465)
Embedded conversion feature in notes	$3,173,896	(1,312,851)	(1,861,045)
Financing costs	—	—	(552,391)
Amortization of debt discount	—	—	1,830,012
Totals, net	$5,321,470	$(2,143,960)	$3,248,731

On September 23, 2016, the Company issued a promissory note to Network Victory Limited (“NVL”) in the aggregate principal amount of $250,000 in respect of a bridge loan made by such party. The promissory note, which bears interest at 18% per annum, may, at NVL’s option, be exchanged for securities issued in a subsequent financing by the Company.

(6) DERIVATIVE LIABILITIES

As a result of having warrants which are outstanding, issued in connection with a 2012 Credit Facility (which was terminated in October 2014), the Company is required to record the changes in the value of these derivative warrants through their expirations in November 2017. Additionally as indicated in Note 5 above, Notes and Warrants issued in connection with the Company’s January and May 2016 secured convertible note financing, included certain price/conversion features, which require them to be accounted for as derivatives.

The table below presents the changes in the derivative liability, which is measured at fair value on a recurring basis and classified as Level 3 in fair value hierarchy:

	09/30/16	12/31/15
Derivative liabilities as of January 1	$127,000	$208,155
Secured convertible note derivatives:
Warrants	2,147,574	—
Embedded conversion feature in Notes	3,173,896	—
Loss (gain) on revaluation	(4,437,776)	(81,155)
Derivative liabilities as of end of period	$1,010,694	$127,000

None of the derivative warrants were exercised in 2016 or 2015 pursuant to cashless exercise provisions.

(7) NET LOSS PER SHARE

For the three months ended September 30, 2016 dilutive EPS includes 5,657,824 incremental shares attributable to the assumed conversion of the January 29, 2016 and May 3, 2016 secured convertible notes and an adjustment of $2,720,727 in net loss for the change in fair value of the related conversion option for such period. No such incremental shares were noted for the nine month period as the calculation is anti-dilutive.

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(8) EQUITY COMPENSATION PLANS

In March 2003, the Company’s shareholders approved its 2003 Stock Option and Incentive Plan (the “2003 Plan”). Pursuant to the 2003 Plan, the Company’s Board of Directors (or its committees and/or executive officers delegated by the Board of Directors) may grant incentive and nonqualified stock options, restricted stock, and other stock-based awards to the Company’s employees, officers, directors, consultants and advisors. As of September 30, 2016, there were 5,000 restricted shares of Common Stock issued and options to purchase an aggregate of 26,500 shares of Common Stock outstanding under the 2003 Plan and no shares are available for future grants due to the 2003 Plan’s expiration.

In May 2008, the Company’s shareholders approved the 2008 Equity Compensation Plan, as amended (the “2008 Plan”). The 2008 Plan provides for grants of incentive stock options to employees and nonqualified stock options and restricted stock to employees, consultants and non-employee directors of the Company. The maximum number of shares available under the 2008 Plan is 10,000,000 shares. As of September 30, 2016, there were 288,866 restricted shares of Common Stock issued and options to purchase 2,403,565 shares of Common Stock outstanding under the 2008 Plan and 7,284,069 shares available for future grants.

The following table shows the remaining shares available for future grants for each plan and outstanding shares:

	Equity Compensation Plans		Not Pursuant
	2003 Plan	2008 Plan	to a Plan
Shares Available For Issuance
Total reserved for stock options and restricted stock	160,000	10,000,000
Net restricted stock issued net of cancellations	(5,000)	(288,866)
Stock options granted	(154,449)	(4,293,693)
Add back options cancelled before exercise	92,349	1,866,628
Less shares no longer available due to Plan expiration	(92,900)	—
Remaining shares available for future grants at September 30, 2016	—	7,284,069

Stock options granted	154,449	4,293,693	310,000
Less: Stock options cancelled	(92,349)	(1,866,628)	(243,333)
Stock options exercised	(35,600)	(23,500)	(66,667)
Net shares outstanding before restricted stock	26,500	2,403,565	—
Net restricted stock issued net of cancellations	5,000	288,866	6,485
Outstanding shares at September 30, 2016	31,500	2,692,431	6,485

(9) STOCK OPTIONS

The fair value of each stock option award is estimated on the date of grant using the Black-Scholes option pricing model with certain assumptions noted below. Expected volatilities are based on historical volatility of the Common Stock using historical periods consistent with the expected term of the options. The Company uses historical data, as well as subsequent events occurring prior to the issuance of the financial statements, to estimate option exercise and employee termination and forfeitures within the valuation model. The expected term of stock options granted under the Company’s stock plans is based on the average of the contractual term (generally 10 years) and the vesting period (generally 24 to 42 months). The risk-free rate is based on the yield of a U.S. Treasury security with a term consistent with the option.

For options issued and outstanding during the nine month periods ended September 30, 2016 and 2015, the Company recorded additional paid-in capital and non-cash compensation expense of $521,494 and $756,000, respectively, each net of estimated forfeitures.

The assumptions used principally for stock options granted to employees and members of the Company’s Board of Directors in the nine months ended September 30, 2016 and 2015 were as follows:

	2016	2015
Risk-free interest rate %	0.18 – 1.07	1.46 – 1.90
Expected dividend yield	—	—
Expected term - years	.25 – 4	5 – 5.5
Forfeiture rate % (excluding fully vested stock options)	2 – 5	7.5 - 15
Expected volatility %	0.94 – 1.28	0.92 – 0.93

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A summary of stock option activity for the nine months ended September 30, 2016 is as follows:

Stock Options	Shares	Weighted- Average Exercise Price	Weighted- Average Remaining Contractual Term (years)	Aggregate Intrinsic Value
Outstanding options at January 1, 2016	1,667,233	$2.01
Granted	1,222,810	$1.28
Exercised	(10,500)	$1.19
Forfeited or expired	(449,478)	$2.47
Outstanding options at September 30, 2016	2,430,065	$1.56	8.63	$—
Exercisable options at September 30, 2016	1,622,072	$1.59	8.48	$—

The weighted-average grant-date fair value of stock options granted for the nine months period ended September 30, 2016 was $1.28 per share. As of September 30, 2016, there was $435,072 of total unrecognized compensation expense related to non-vested share-based option compensation arrangements. With the exception of the unrecognized share-based compensation related to certain restricted stock grants to officers and employees that contain performance conditions related to FDA approval for the Company’s CGM system or the sale of substantially all of the stock or assets of the Company, unrecognized compensation is expected to be recognized over the next four years.

(10) RESTRICTED STOCK

For restricted stock issued and outstanding during the nine months ended September 30, 2016 and 2015, the Company incurred non-cash compensation expense of $181,369 and $42,000, respectively, each net of estimated forfeitures.

During the nine months ended September 30, 2016, the Company granted 280,000 restricted shares of Common Stock to its officers and Vice President of Operations and Product Development of the Company, in connection with their respective salary deferrals.

A summary of non-vested restricted stock activity for the nine months ended September 30, 2016 is as follows:

Restricted Stock	Shares	Weighted- Average Grant-Date Fair Value
Non-vested shares at January 1, 2016	27,842	$13.06
Granted	280,000	$1.13
Vested	(2,020)	$8.68
Forfeited	(5,471)	$7.67
Non-vested shares at September 30, 2016	300,351	$2.07

Among the 300,351 shares of non-vested restricted stock, the various vesting criteria include the following:

●

14,185 shares of restricted stock vest upon the FDA approval of the Company’s CGM system or the sale of the Company; and

●

6,166 shares of restricted stock vest over 4 years, at each of the anniversary dates of the grants, and

●

130,000 shares of restricted stock vest 18 months from the date of issuance, and

●

150,000 shares of restricted stock vest quarterly after the company receives debt/equity financing of at least $1 million

As of September 30, 2016, there was $438,429 of total unrecognized compensation expense related to non-vested share-based restricted stock arrangements granted pursuant to the Company’s equity compensation plans that vest over time in the foreseeable future. As of September 30, 2016, the Company cannot estimate the timing of completion of performance vesting requirements required by certain of these restricted stock grant arrangements. Compensation expense related to these restricted share grants will be recognized when the Company concludes that achievement of the performance vesting conditions is probable.

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(11) WARRANTS

In the nine months ended September 30, 2016, the Company issued warrants to purchase 3,552,875 shares of the Company’s common stock in connection with its Note financing. See Note 5.

A summary of warrant activity for the nine months ended September 30, 2016 is as follows:

Warrants	Shares	Weighted- Average Exercise Price
Outstanding warrants at January 1, 2016	4,530,428	$3.68
Granted	3,552,875	$1.50
Forfeited	—	$—
Outstanding warrants at September 30, 2016	8,083,303	$2.72

At September 30, 2016, the Company had the following outstanding warrants:

Type of Warrant/ Range of Exercise Prices		Expirations	Number Outstanding	Weighted-Average Remaining Contractual Life (years)	Weighted- Average Exercise Price	Number Exercisable
Derivative:
	$1.50	7/29/21	1,274,280	4.83	$1.50	1,274,280
	$1.50	5/3/18	2,278,595	1.59	$1.50	2,278,595
	$7.50	8/31/17 to 11/6/17	700,000	0.97	$7.50	700,000
Equity:
	$2.75 - $3.00	12/10/18 to 10//30/20	3,830,428	3.44	$2.98	3,830,428
Total outstanding			8,083,303			8,083,303

The Company uses valuation methods and assumptions that consider among other factors the fair value of the underlying stock, risk-free interest rate, volatility, expected life and dividend rates in estimating fair value for the warrants considered to be derivative instruments.

The following assumptions were utilized by the Company:

By expiration:	7/29/21	5/3/18	8/31/17 - 11/6/17
Risk-free interest rate %	1.03	0.56	0.73
Expected dividend yield	—	—	—
Expected term - years (contractual term)	5.15	1.87	1.17 - 1.35
Forfeiture rate	—	—	—
Expected volatility %	103	103	84.95
Timing of down-round triggering event	August 2016	August 2016	N/A

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Expected volatilities are based on historical volatility of the Common Stock using historical periods consistent with the expected term of the warrant. The risk-free rate is based on the yield of a U.S. Treasury security with a term consistent with the warrant.

(12) LITIGATION & OTHER SIGNIFICANT MATTERS

From time to time, the Company is subject to legal proceedings, claims, investigations, and proceedings in the ordinary course of business. In accordance with generally accepted accounting principles, the Company makes a provision for a liability when it is both probable that a liability has been incurred and the amount of the loss or range of loss can be reasonably estimated. These provisions, if any, are reviewed at least quarterly and adjusted to reflect the impacts of negotiations, settlements, rulings, advice of legal counsel, and other information and events pertaining to a particular case. Litigation is inherently unpredictable. At September 30, 2016, no litigation loss is deemed probable or reasonably estimated.

On September 23, 2016, Scott W. Hollander, President and Chief Executive Officer and a director of the Company, and the Company entered into a separation agreement (the “Separation Agreement”) pursuant to which the parties mutually agreed to Mr. Hollander’s separation from the Company, effective September 23, 2016 (the “Separation Date”). Under the Separation Agreement, Mr. Hollander will receive: (i) severance pay equal to the gross amount of $420,000 (the “Severance Amount”), less applicable federal, state and local withholding and taxes, payable in monthly amounts of $17,500 commencing on October 15, 2016, subject to increase to $25,000 per month if the Company shall consummate a debt or equity financing as described in Section 3(a)(ii) of the Severance Agreement, until the Severance Amount is fully paid; (ii) 150,000 shares of restricted stock previously awarded in March 2016 pursuant to a restricted stock agreement shall vest in quarterly installments of 37,500 shares; (iii) accelerated vesting of all unvested stock options previously awarded to him in December 2014 and March 2016 with three (3) months from the Separation Date to exercise such options; and (iv) reimbursement of COBRA payments for up to eighteen (18) months.

(13) SUBSEQUENT EVENTS

On October 19, 2016, the Company issued a promissory note to Network Victory Limited in the aggregate principal amount of $125,000 in respect of a bridge loan made by such party. The promissory note, which bears interest at 18% per annum, may, at NVL’s option, be exchanged for securities issued in a subsequent financing by the Company.

On October 28, 2016, the Company issued stock options to its employees and a certain consultant aggregating 131,155 shares to purchase our common stock at $0.45 per share. These options vest in one year.

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ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OFOPERATIONS.

The following discussion of our financial condition and results of operations should be read in conjunction with the financial statements and the related notes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2015 and elsewhere in this report. The matters discussed herein contain forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and Section 27A of the Securities Act of 1933, as amended, which involve risks and uncertainties. This Annual Report on Form 10-K contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and Section 27A of the Securities Act of 1933, as amended, which involve risks and uncertainties. All statements other than statements of historical information provided herein may be deemed to be forward-looking statements. Without limiting the foregoing, the words “believes,” “anticipates,” “plans,” “expects” and similar expressions are intended to identify forward-looking statements. Factors that could cause actual results to differ materially from those reflected in the forward-looking statements include, but are not limited to, those discussed elsewhere in this report and the risks discussed in our other filings with the Securities and Exchange Commission (the “SEC”). Readers are cautioned not to place undue reliance on these forward-looking statements, which reflect management’s analysis, judgment, belief or expectation only as of the date hereof. Except as required by law, we undertake no obligation to publicly revise these forward-looking statements to reflect events or circumstances that arise after the date hereof.

Business

We are a medical device company with expertise in advanced skin permeation technology. We are developing a non-invasive, wireless continuous glucose monitoring (CGM) system for initial use in the outpatient diabetes market and potentially in the wearable-health consumer market. The transdermal skin preparation component of our CGM system allows for enhanced skin permeation that will enable extraction of analytes such as glucose, enhanced delivery of topical pharmaceuticals and other applications.

Research and Development

We believe that ongoing research and development (“R&D”) efforts are essential to our success. A major portion of our operating expenses to date is related to our research and development activities. R&D expenses generally consist of internal salaries and related costs, and third-party vendor expenses for product design and development. In addition, R&D costs include regulatory consulting, feasibility product testing (internal and external) and conducting nonclinical and clinical studies. R&D expenses were $1,943,287 for the nine months ended September 30, 2016. We intend to maintain our commitment to R&D as an essential component of our product development efforts. Our ability to raise sufficient financing may impact our level of R&D spending and progress towards milestones.

Critical Accounting Policies and Estimates

Our consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America. The preparation of these consolidated financial statements requires Management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period.

On an ongoing basis, we evaluate our estimates and judgments for all assets and liabilities, including those related to long-lived asset impairment, stock-based compensation expense and the fair value of stock purchase warrants classified as derivative liabilities. We base our estimates and judgments on historical experience, current economic and industry conditions and on various other factors that are believed to be reasonable under the circumstances. This forms the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. There have been no changes in our critical accounting policies and estimates subsequent to those disclosed in our Annual Report on Form 10-K as filed with the SEC on March 30, 2016.

We believe that full consideration has been given to all relevant circumstances that we may be subject to, and the consolidated financial statements accurately reflect our best estimate of the results of operations, financial position and cash flows for the periods presented.

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Results of Operations

Comparison of the Three and Nine Months ended September 30, 2016 and 2015

Net income (loss) — As a result of the factors described below, we had a net income (loss) of $(4,767,805) and $794,171 for the nine and three months ended 2016, respectively, compared to $(20,921,732) and $(1,775,422) for the nine and three months ended 2015, respectively.

Research and Development Expenses — R&D expenses increased by $29,556, or 5%, to $588,551 for the three months ended 2016 from $558,995 for the same period in 2015. R&D expenses represented 29% and 38% of total operating expenses during the three months ended 2016 and 2015, respectively. The increase in R&D expenses for the quarter was primarily attributable to an increase in rent expense of approximately $86,000, offset by a decline in wages and outside consultant costs of $23,000 as well as a decline in contracted services of $31,000. We incurred some unplanned turnover in our staffing during the quarter exemplary of a better economic climate.

R&D expenses decreased by $84,609, or 4%, to $1,943,287 for the nine months ended 2016 from $2,027,896 for the same period in 2015. R&D expenses represented 38% and 31%, of total operating expenses (excluding the impairment charge in 2015) during the nine months ended 2016 and 2015, respectively. The decrease in R&D expenses for the nine months was primarily attributable to lower facility costs of approximately $79,000.

We relocated our research facilities in July 2015 to less costly and more efficient space. Since we successfully terminated our lease in Franklin, Massachusetts early in 2015 we wrote off a large deferred credit for the difference between the actual rent charge and the straight line amortized amount which we were carrying on our balance sheet. This resulted in a rent credit in the third quarter of 2015 lowering our quarterly 2015 rent expense. R&D expenses for the quarter and nine months 2016 were additionally impacted by $25,170 and $267,811, respectively, of capitalized software development costs, consisting of contracted services, related to a smartphone API used with our CGM.

During the third quarter of 2016, the Research and Development team split its focus between supporting our Chinese partner, Medical Technologies Innovation Asia, Ltd. (MTIA) with respect to our older CGM product, and continuing to develop and test the NextGen CGM system.

In order to improve clinical performance of the older CGM product that MTIA is testing, the R&D team made a number of specific updates to the design of the Exfoliator and the Sensor Module. Extensive clinical testing was done both before the changes were made and afterwards. MTIA is now transferring these changes into their production facilities and will be completing the design verification activities, prior to the initiation of the CFDA clinical trial.

While this focus on improving the older generation product has enabled MTIA to make more forward progress in moving this system forward towards an anticipated approval in China, the effort resulted in a delay in the development our NextGen system. Furthermore, a lack of adequate funding has delayed the critical R&D spending necessary to complete the design. Once funding has been re-established a new set of milestones will be published.

Despite the focus on the older generation and the funding issues, the R&D team continued to make progress in the development and testing of the NextGen system. The team began testing its sensor with a hydrogel that is kept wet until time of use.

Rigorous testing of each component independently and as an integrated system will continue as the Company optimizes its system in preparation for future clinical and regulatory trials. With respect to specific components of the NextGen system, our progress was as follows during this third quarter:

●

Skin Preparation Device: We continued hardware and software testing of the NextGen Exfoliator. In addition, a new design for the abrasive tip has been tested with excellent results. This new self-exfoliator will be lower cost, easier to use and fully integrated with the new sensor and Target Base.

●

Sensor: We continued internal clinical testing of our NextGen sensor module, using a “wet” version of the hydrogel. This new module includes a new sensor element, new hydrogel and a new housing. Echo selected a local partner to help develop a prototype production process for the most complicated parts of the NextGen sensor module.

●

Transmitter & software: We continued to develop new embedded software for use in the reusable transmitter and continued the integration testing of the hardware and software elements. The new software is designed to be compatible with our Android based Application Programming Interface (API) and software application (APP).

●

Application Programming Interface: We completed verification testing of the API that will allow Android programmers to write APPs that use our sensors.

●

CGM APP: We have completed a CGM APP that will be able to display glucose information from either the original Echo technology, or the NextGen sensor.

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Selling, General and Administrative Expenses — S,G&A expenses increased by $377,666, or 46%, to $1,198,328 for the three months ended 2016 from $820,662 for the same period in 2015. S,G&A expenses represented 66% and 56% of total operating expenses during the quarter ended 2016 and 2015, respectively. We saw a net increase in salary and other benefits of $363,000 in this quarter which was primarily attributable to severance payable to our chief executive officer of approximately $462,000. This is also inclusive of share-based compensation charges for the accelerated vesting of our former CEO’s 150,000 shares of restricted stock and options to purchase 500,000 shares of our common stock in accordance with the terms of his separation agreement.

S,G&A expenses decreased by $888,030, or 23%, to $2,927,716 for the nine months ended 2016 from $3,815,746 for the same period in 2015. S,G&A expenses represented 59% and 58% of total operating expenses (excluding the impairment charge in 2015) during the nine months ended 2016 and 2015, respectively. The decline for the 2016 quarter was attributable to approximate declines in: legal fees of $804,000, salary and benefits of $130,000, telephone and internet expenses of $73,000, information technology costs of $51,000, insurance expense of $70,000, relocation costs of $35,000, rent of $21,000, and website costs of $10,000. These declines were offset by an approximate increase in investor relations charges of $87,000 as well as increased costs relative to our former chief executive’s separation agreement more fully described above.

In 2015, the Company settled its litigation with the former CEO, Patrick Mooney, and has not had any significant litigation since, causing the decrease in legal fees. In 2015, we settled a long duration contract with an internet vendor that resulted in $40,000 of early termination expenses. In 2015 we relocated both our Philadelphia and Franklin, MA facilities. During 2016 we reduced our overall director and officer coverage from the prior year resulting in lower premium charges. Stock compensation for 2015 included the stock compensation for new board members as well as recently hired executive staff, which was not present in 2016.

Impairment Charge — The Company reviews long-lived assets for impairment whenever events or changes in circumstances indicate that the asset’s carrying amount may not be recoverable. The Company conducts its long-lived asset impairment analyses by grouping assets and liabilities at the lowest level for which identifiable cash flows are largely independent of the cash flows of other assets and liabilities and evaluate the asset group against the sum of the undiscounted future cash flows. If the undiscounted cash flows do not indicate the carrying amount of the asset is recoverable, an impairment charge is measured as the amount by which the carrying amount of the asset group exceeds its fair value based on discounted cash flow analysis or appraisals. In connection with the preparation of the financial statements in the second quarter of fiscal 2015, the Company concluded it had a triggering event requiring assessment of impairment for its intangibles in conjunction with an expected out-licensing strategy that new management had hoped to pursue. Extremely limited financial resources coupled with the remaining short patent lives, discussions with previous consultants regarding their progress with bringing value to the intangibles, a review of competitive formulations and discussions with new consultants to explore out-licensing strategies led newly-hired corporate management to conclude it was best to abandon its initial hope to garner value from its intangibles. Accordingly, due to this change in strategy, no monies are now expected to be obtained relating to the Azone Drug Master File, the Durhalieve and MAZ Investigational New Drug applications and the MAZ Orphan Drug application (collectively, the AzoneTS-based technology acquired in 2007) intangibles. As a result, the Company reviewed its intangibles for impairment and recorded a $9.625 million impairment charge, or the full value of the intangibles, on the consolidated statement of operations in the second quarter of 2015.

Loss on disposal of property and equipment — We recorded a gain for the quarter and nine months 2016 of $4,000 on the sale of certain excess fully depreciated equipment. The loss on disposal of $39,382 and $278,816 for the quarter and nine months ended 2015 represented furniture and fixtures that were sold and the write-off of leasehold improvements in our Philadelphia office when we relocated to the Iselin, New Jersey office in January 2015.

Depreciation and amortization expense — Depreciation expense decreased by $12,246 and $402,401 for the quarter and nine months ended 2016, to $26,925 and $85,090 from $39,171 and $487,491 for the same periods in 2015. This decline reflects the write-off of a substantial amount of leasehold improvements due to our relocations of our Massachusetts research facility and Philadelphia corporate office in 2015.

Gain (loss) on revaluation of derivative liabilities — Changes in the fair value of derivative financial instruments are recognized each period as a derivative gain or loss. The primary underlying risk exposure pertaining to the secured convertible notes, consisting of derivative warrants and embedded conversion options, and other derivative warrants, is the change in fair value of the underlying common stock. The gain (loss) on revaluation of the derivative liabilities for the quarter ended 2016 and 2015 was $3,675,826 and $(54,000), respectively, and for the nine months ended 2016 and 2015, $4,437,776 and $(61,845), respectively.

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Financing gain (loss) — This is a non-cash charge with two components representing: (i) the excess value given to investors in 2015, who received shares of Series F Stock and warrants to purchase the same number of shares of our common stock, when the closing market price was above the $1.50 purchase price they paid for their shares and warrants. We recorded a non-cash charge of $3,938,000 related to these investors, and (ii) the potential excess future value represented by the 333,333 shares and warrants to purchase the same number of shares for the remaining $500,000 of investment still outstanding under our December 2014 financing, based on our closing market price at June 30, 2015 of $1.70. We recorded a non-cash charge of $419,000 related to these future investments. For the quarter ended 2015 we recorded a loss of $263,000 representing the difference between what we had estimated the value of the derivative transactions would cost the Company at the end of the first quarter and what they actually represented during the third quarter.

Loss on early extinguishment of bridge loans — We recorded a loss on early extinguishment of these bridge loans of $2,143,960 for the nine months ended 2016 representing the aggregate excess consideration of the Notes and warrants exchanged for the bridge loans.

Amortization of debt discount — $934,794 and $1,830,012 for the quarter and nine months ended 2016 represents the amortization of the various components offsetting the Notes issued on January 29, 2016 and May 3, 2016 over the one year respective terms of the Notes. Such amounts consisted of amortization of debt issuance costs, and values related to the derivative warrants and embedded conversion features that were not exchanged, respectively.

Interest Expense — Interest expense increased to $133,057 and $279,616 for the quarter and nine months ended 2016 from $212 and $4,938 for similar periods in 2015, respectively. The increase is primarily related to the 10% interest on the secured convertible notes payable.

Deemed Dividend on Beneficial Conversion Feature of Preferred Stock — In connection with the sale of Secured convertible notes, we agreed to give the holders of Series F Convertible Preferred Stock the same rights as the holders of the Notes, i.e., a reset of their conversion price calculated during the ninety day period post the April 29, 2016 effective registration. This modification to the conversion rights of the Series F shares increased the value of the Series F and caused us to record a deemed dividend of $6,460,818 calculated using a Monte Carlo Valuation Model.

Liquidity and Capital Resources

We have financed our operations since inception primarily through sales of our equity, the issuance of convertible promissory notes, draws from a non-revolving credit facility, unsecured and secured promissory notes, non-refundable payments received under license agreements and cash received in connection with exercises of Common Stock options and warrants. As of September 30, 2016, we had $172,725 of cash and cash equivalents, with no other short-term investments.

Cash Flows for the Nine Months ended September 30, 2016

Net cash used in operating activities was $4,167,436. The use of cash in operating activities was primarily attributable to the net loss of $4,767,905 offset by non-cash expenses of $85,090 for depreciation and amortization, $1,830,012 for amortization of debt discount, $702,863 for share-based compensation expense, a loss on early extinguishment of bridge loans of $2,143,960, a gain on revaluation of $4,437,776 related to derivative credit facility warrants as well as derivative warrants and derivative embedded conversion feature of our secured convertible notes, a gain on the disposal of fixed assets of $4,000, offset decreases in: prepaid and other of $15,318, accounts payable of $152,153 and accrued expenses of approximately $417,156.

Net cash used in investing activities was $251,296. The Company suffered a minor charge to its letter of credit due to the landlord requiring a payment for certain construction related activities prior to its relocation to the Littleton, MA location. The Company capitalized software development costs of $267,811, had proceeds from the sale of assets of $4,000, and the Company purchased property and equipment of $6,354.

Net cash provided by financing activities was $4,535,247. We received $2,512,609 of net proceeds from our secured convertible notes as well as $2,000,000 from bridge loans received in the period subsequent to the closing of the January 29, 2016 financing. We also received $199,671 of insurance premium financing. Principal payments made on the premium financing used were $177,033.

On September 23, 2016, we issued a promissory note to Network Victory Limited (“NVL”) in the aggregate principal amount of $250,000 in respect of a bridge loan made by such party. The promissory note, which bears interest at 18% per annum, may, at NVL’s option, be exchanged for securities issued in a subsequent financing by the Company.

On October 19, 2016, we issued a promissory note to NVL in the aggregate principal amount of $125,000 in respect of a bridge loan made by such party. The promissory note, which bears interest at 18% per annum, may, at NVL’s option, be exchanged for securities issued in a subsequent financing by the Company.

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Effect of Inflation and Changes in Prices

We do not believe that inflation and changes in prices will have a material effect on our operations.

ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK.

Not applicable.

ITEM 4. CONTROLS AND PROCEDURES.

Disclosure Controls and Procedures

We maintain “disclosure controls and procedures,” as such term is defined in Rule 13a-15(e) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”). In designing and evaluating our disclosure controls and procedures, our management recognized that disclosure controls and procedures, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of disclosure controls and procedures are met. Additionally, in designing disclosure controls and procedures, our management necessarily was required to apply its judgment in evaluating the cost-benefit relationship of possible disclosure controls and procedures. The design of any disclosure controls and procedures also is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions.

As of the end of the period covered by this Quarterly Report on Form 10-Q, we carried out an evaluation, under the supervision and with the participation of our management, including our Chief Financial Officer, of the effectiveness of our disclosure controls and procedures as defined in Rule 13a-15(e) and 15d-15(e) of the Exchange Act. Based on that evaluation and the material weaknesses described below, our Chief Financial Officer concluded that our disclosure controls and procedures were not effective as a result of the material weaknesses.

Our Chief Financial Officer concluded that as of September 30, 2016 the following material weaknesses existed:

(1) We lacked a sufficient complement of personnel with an appropriate level of knowledge and experience in the application of U.S. generally accepted accounting principles, or GAAP, commensurate with our financial reporting requirements. The monitoring of our accounting and reporting functions were either not designed and in place or not operating effectively, and

(2) We lacked the quantity of resources to implement an appropriate level of review controls to properly evaluate the completeness and accuracy of transactions entered into by our Company.

Our management believes that these weaknesses are due in part to the small size of our staff and limited funding which makes it challenging to maintain adequate disclosure controls. To remediate the material weaknesses in disclosure controls and procedures, we have sought assistance with complex filing matters beginning in 2016 and continue to take additional steps to improve our financial reporting systems and implement new policies, procedures and controls.

Internal Control over Financial Reporting

There was no change in our internal control over financial reporting (as defined in Rule 13a-15(f) of the Exchange Act) that occurred during the fiscal quarter to which this report relates that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

PART II—OTHER INFORMATION

ITEM 6. EXHIBITS.

The Exhibits listed in the Exhibit Index immediately preceding such Exhibits are filed with or incorporated by reference in this report, except as noted.

-17-

Table of Contents

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

Date: November 16, 2016

ECHO THERAPEUTICS, INC.

By: /s/ Alan W. Schoenbart

Alan W. Schoenbart

Chief Financial Officer

(Principal Executive Officer)

By: /s/ Alan W. Schoenbart

Alan W. Schoenbart

Chief Financial Officer

(Principal Financial and Accounting Officer)

-18-

Table of Contents

EXHIBIT INDEX

Exhibit No.	Description
10.1	Promissory Note with Network Victory Limited dated September 23, 2016 is incorporated by reference to Exhibit 10.1 on the Company’s Current Report on Form 8-K filed September 23, 2016.
10.2	Separation Agreement, dated as of September 23, 2016, between Scott W. Hollander and Echo Therapeutics, Inc.2016 is incorporated by reference to Exhibit 10.2 on the Company’s Current Report on Form 8-K filed September 23, 2016.
31.1	Certification of the Principal Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
31.2	Certification of the Principal Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
32.1	Certification of the Principal Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
32.2	Certification of the Principal Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
101	The following materials from the Registrant’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2016, formatted in XBRL (Extensible Business Reporting Language), (i) Consolidated Balance Sheets, (ii) Consolidated Statements of Operations, (iii) Consolidated Statements of Cash Flows, and (iv) Notes to Consolidated Financial Statements.

-19-

EX-31.1 2 ex31-1.htm CERTIFICATION PURSUANT TO RULE 13A-14(A)/15D-14(A) CERTIFICATIONS SECTION 302 OF THE SARBANES-OXLY ACT OF 2002 SEC Connect

Exhibit 31.1

CERTIFICATION PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002

I, Alan W. Schoenbart, certify that:

1. I have reviewed this Quarterly Report on Form 10-Q of Echo Therapeutics, Inc. (the “Company”) for the quarter ended September 30, 2016;

Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material factnecessary to make the statements made, in light of the circumstances under which such statements were made, notmisleading with respect to the period covered by this report;

Based on my knowledge, the financial statements, and other financial information included in this report, fairly present inall material respects the financial condition, results of operations and cash flows of the Company as of and for the periodspresented in this report;

The Company’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the Company and have:

(a)

Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the Company, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period on which this report is being prepared;

(b)

Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

(c)

Evaluated the effectiveness of the Company’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures as of the end of the period covered by this report based on such evaluation; and

(d)

Disclosed in this report any change in the Company’s internal control over financial reporting that occurred during the Company’s most recent fiscal quarter that has materially affected, or is reasonably likely to materially affect, the Company’s internal control over financial reporting; and

The Company’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control overfinancial reporting, to the Company’s auditors and the audit committee of the Company’s Board of Directors:

(a)

All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the Company’s ability to record, process, summarize and report financial information; and

(b)

Any fraud, whether or not material, that involves Management or other employees who have a significant role in the Company’s internal control over financial reporting.

Date: November 16, 2016

/s/ Alan W. Schoenbart

Alan W. Schoenbart

Chief Financial Officer

(Principal Executive Officer)

EX-31.2 3 ex31-2.htm CERTIFICATION PURSUANT TO RULE 13A-14(A)/15D-14(A) CERTIFICATIONS SECTION 302 OF THE SARBANES-OXLY ACT OF 2002 SEC Connect

Exhibit 31.2

CERTIFICATION PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002

I, Alan W. Schoenbart, certify that:

1. I have reviewed this Quarterly Report on Form 10-Q of Echo Therapeutics, Inc. (the “Company”) for the quarter ended September 30, 2016;

(a)

(b)

(c)

(d)

(a)

(b)

Any fraud, whether or not material, that involves Management or other employees who have a significant role in the Company’s internal control over financial reporting.

Date: November 16, 2016

/s/ Alan W. Schoenbart

Alan W. Schoenbart

Chief Financial Officer

(Principal Financial and Accounting Officer)

EX-32.1 4 ex32-1.htm CERTIFICATE PURSUANT TO SECTION 18 U.S.C. PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002 SEC Connect

Exhibit 32.1

CERTIFICATION PURSUANT TO 18 U.S.C. SECTION 1350,

AS ADOPTED PURSUANT TO

SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

In connection with the Quarterly Report on Form 10-Q of Echo Therapeutics, Inc. (the “Company”) for the quarter ended September 30, 2016 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Alan W. Schoenbart, Chief Financial Officer of the Company, certify, pursuant to 18 U.S.C. §1350, as adopted pursuant to §906 of the Sarbanes-Oxley Act of 2002:

1. The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

/s/ Alan W. Schoenbart

Alan W. Schoenbart

Chief Financial Officer

(Principal Executive Officer)

Date: November 16, 2016

EX-32.2 5 ex32-2.htm CERTIFICATE PURSUANT TO SECTION 18 U.S.C. PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002 SEC Connect

Exhibit 32.2

CERTIFICATION PURSUANT TO 18 U.S.C. SECTION 1350,

AS ADOPTED PURSUANT TO

SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

1. The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

/s/ Alan W. Schoenbart

Alan W. Schoenbart

Chief Financial Officer

(Principal Financial and Accounting Officer)

Date: November 16, 2016

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Echo Therapeutics, Inc. (the "Company") is a medical device company with expertise in advanced skin permeation technology. The Company is developing its non-invasive, wireless continuous glucose monitoring (CGM) system with potential use in the outpatient diabetes market. A significant opportunity may also exist in the wearable-health consumer market and in the hospital setting. Echo has also developed its needle-free skin preparation device as a platform technology that allows for enhanced skin permeation enabling extraction of analytes, such as glucose, enhanced delivery of topical pharmaceuticals and other applications.   The accompanying unaudited condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiary, Sontra Medical, Inc., a Delaware corporation. All significant intercompany balances and transactions have been eliminated in consolidation. These financial statements have been prepared in conformity with generally accepted accounting principles (“GAAP”) in the United States consistent with those applied in, and should be read in conjunction with, the Company’s audited consolidated financial statements and related footnotes for the year ended December 31, 2015 included in the Company’s Annual Report on Form 10-K as filed with the United States Securities and Exchange Commission (“SEC”) on March 30, 2016. These financial statements reflect all adjustments, consisting only of normal recurring adjustments, which are, in the opinion of management, necessary for a fair presentation of the Company’s financial position as of September 30, 2016 and its results of operations and cash flows for the interim periods presented and are not necessarily indicative of results for subsequent interim periods or for the full year. These interim financial statements do not include all of the information and footnotes required by GAAP for complete financial statements as allowed by the relevant SEC rules and regulations; however, the Company believes that its disclosures are adequate to ensure that the information presented is not misleading. Certain amounts in prior periods have been reclassified to conform to the current presentation.

The accompanying financial statements have been prepared on a basis that assumes that the Company will continue as a going concern and that contemplates the continuity of operations, the realization of assets and the satisfaction of liabilities and commitments in the normal course of business. As of September 30, 2016, the Company had cash of $172,725, working capital deficit of ($6,865,405) and an accumulated deficit of ($154,897,838). The Company continues to incur recurring losses from operations. The Company’s losses have resulted principally from costs incurred in connection with its research and development activities and from general and administrative costs associated with its operations. The Company also expects to have negative cash flows for the foreseeable future as it funds its operational losses and capital expenditures. This will result in decreases in the Company’s working capital, total assets and stockholders’ equity, which may not be offset by future funding. The Company will need to secure additional capital to fund its product development, research, manufacturing and clinical programs in accordance with its current planned operations. The Company has funded its operations in the past primarily through debt and equity issuances. Management will continue to pursue financing to fund its operations. No assurances can be given that additional capital will be available on terms acceptable to the Company. The accompanying financial statements do not include any adjustments that might result from the outcome of the uncertainty.

The principal categories and estimated useful lives of property and equipment were: <table cellspacing="0" cellpadding="0" style="font: 12pt Times New Roman, Times, Serif; width: 100%"> <tr style="vertical-align: bottom"> <td> </td> <td style="padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: black 1pt solid">   09/30/16</td> <td style="padding-bottom: 1.5pt"> </td> <td style="padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: black 1pt solid">   12/31/15</td> <td style="padding-bottom: 1.5pt"> </td> <td style="padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: black 1pt solid"> Estimated Useful Lives</td> <td style="padding-bottom: 1.5pt"> </td></tr> <tr style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="width: 64%; text-align: justify">Computer equipment </td> <td style="width: 1%"> </td> <td style="width: 1%">$</td> <td style="width: 9%; text-align: right">335,298</td> <td style="width: 1%"> </td> <td style="width: 1%"> </td> <td style="width: 1%">$</td> <td style="width: 9%; text-align: right">332,764</td> <td style="width: 1%"> </td> <td style="width: 1%"> </td> <td style="width: 1%"> </td> <td style="width: 9%; text-align: right">3</td> <td style="width: 1%"> </td></tr> <tr style="vertical-align: bottom; background-color: White"> <td style="text-align: justify">Office and laboratory equipment </td> <td> </td> <td> </td> <td style="text-align: right">603,226</td> <td> </td> <td> </td> <td> </td> <td style="text-align: right">628,726</td> <td> </td> <td> </td> <td> </td> <td style="text-align: right">3-5</td> <td> </td></tr> <tr style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="text-align: justify">Furniture and fixtures </td> <td> </td> <td> </td> <td style="text-align: right">228,099</td> <td> </td> <td> </td> <td> </td> <td style="text-align: right">228,099</td> <td> </td> <td> </td> <td> </td> <td style="text-align: right">7</td> <td> </td></tr> <tr style="vertical-align: bottom; background-color: White"> <td style="text-align: justify">Manufacturing equipment </td> <td> </td> <td> </td> <td style="text-align: right">65,819</td> <td> </td> <td> </td> <td> </td> <td style="text-align: right">61,998</td> <td> </td> <td> </td> <td> </td> <td style="text-align: right">5</td> <td> </td></tr> <tr style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="text-align: justify">Leasehold improvements </td> <td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: black 1pt solid"> </td> <td style="border-bottom: black 1pt solid; text-align: right">41,968</td> <td style="padding-bottom: 1.5pt"> </td> <td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: black 1pt solid"> </td> <td style="border-bottom: black 1pt solid; text-align: right">41,968</td> <td style="padding-bottom: 1.5pt"> </td> <td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: black 1pt solid"> </td> <td style="border-bottom: black 1pt solid; text-align: right">3-7</td> <td style="padding-bottom: 1.5pt"> </td></tr> <tr style="vertical-align: bottom; background-color: White"> <td style="text-align: justify">  Total property and equipment</td> <td> </td> <td> </td> <td style="text-align: right">1,274,410</td> <td> </td> <td> </td> <td> </td> <td style="text-align: right">1,293,555</td> <td> </td> <td> </td> <td> </td> <td style="text-align: right"> </td> <td> </td></tr> <tr style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="text-align: justify">Less accumulated depreciation and amortization </td> <td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: black 1pt solid"> </td> <td style="border-bottom: black 1pt solid; text-align: right">1,085,474</td> <td style="padding-bottom: 1.5pt"> </td> <td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: black 1pt solid"> </td> <td style="border-bottom: black 1pt solid; text-align: right">1,025,884</td> <td style="padding-bottom: 1.5pt"> </td> <td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: black 1pt solid"> </td> <td style="border-bottom: black 1pt solid; text-align: right"> </td> <td style="padding-bottom: 1.5pt"> </td></tr> <tr style="vertical-align: bottom; background-color: White"> <td style="text-align: justify"> Property and equipment, net </td> <td style="padding-bottom: 3pt"> </td> <td style="border-bottom: black 1.5pt double">$</td> <td style="border-bottom: black 1.5pt double; text-align: right">188,936</td> <td style="padding-bottom: 3pt"> </td> <td style="padding-bottom: 3pt"> </td> <td style="border-bottom: black 1.5pt double">$</td> <td style="border-bottom: black 1.5pt double; text-align: right">267,671</td> <td style="padding-bottom: 3pt"> </td> <td style="padding-bottom: 3pt"> </td> <td style="border-bottom: black 1.5pt double"> </td> <td style="border-bottom: black 1.5pt double; text-align: right"> </td> <td style="padding-bottom: 3pt"> </td></tr> </table>

On January 29, 2016, the Company entered into a securities purchase agreement (the “Purchase Agreement”) with certain institutional and other accredited investors (the “Investors”) pursuant to which the Company agreed to issue up to $5,148,620 principal amount of 10% senior secured convertible notes of the Company (the “Notes”) and related common stock purchase warrants (the “Warrants”) in two tranches.  The Notes are secured by substantially all of the assets of the Company pursuant to a Security Agreement, dated January 29, 2016 (the “Security Agreement”). The initial closing of $1,787,000 occurred on January 29, 2016.  The second tranche of the financing, or $3,361,620, was subject to the Company obtaining shareholder approval which occurred on April 14, 2016. The Notes and Warrants are subject to customary antidilution provisions. With stockholder approval, the conversion price for the Notes is subject to a reset to eighty percent (80%) of the average of the ten lowest closing prices of the Common Stock less than $1.50 , subject to equitable adjustment, if any, as reported by Bloomberg LP for the principal market on which the Common Stock then trades during the ninety (90) days following the first effective date of a registration statement filed pursuant to the Registration Rights Agreement, but in no event less than $.80, subject to equitable adjustment. For the first closing, bridge notes in the principal amount of $680,000 were surrendered to the Company as payment by certain Investors. This was inclusive of $330,000 of bridge notes outstanding at December 31, 2015 and a $350,000 of promissory notes received at various dates in January 2016 from Beijing Yi Tang Bio Science & Technology, Ltd. (BYT). The Company recorded a loss on early extinguishment of these bridge loans of $415,725, representing the excess value of the consideration consisting of the $680,000 secured convertible note, and a proportional amount of the Warrants totaling $320,761 and the embedded conversion feature of the Notes totaling $94,964, exchanged for certain bridge loans to cancel them. Fees aggregating $368,080 were paid to the placement agent and others. The Notes issued in the first closing are initially convertible into 1,191,333 shares of common stock, par value $.01 per share, of the Company (the “Common Stock”), at $1.50 per share. In connection with the initial closing, the Company issued five-year Class A warrants to purchase 1,274,280 shares of Common Stock, inclusive of Class A warrants to purchase 82,947 share of Common Stock issued to the placement agent, at an exercise price of $1.50 per share, which are not exercisable for six months. These Warrants, whose exercise price is subject to adjustments should the Company consummate a future financing at a price less than $1.50, are considered a derivative. The initial value of these derivative warrants was $901,631 which was determined utilizing a Monte Carlo Binomial Model. The assumptions utilized for these derivative warrants, as well as embedded conversion feature, described hereafter, are disclosed in Note 10. Additionally the Notes contain an embedded conversion feature which adjusts the conversion price should the Company have a price reset during the ninety days after April 29, 2016 (the effective date of the Company’s registration) or consummate a future financing at a price less than $1.50, and is also considered a derivative. A price reset to $0.91 occurred on July 29, 2016 as is further described below. The initial value of the embedded conversion feature within the Notes was $249,559 which was also determined utilizing a Monte Carlo Binomial Model.   On February 4, 2016, the Company issued a promissory note to BYT in the aggregate principal amount of $300,000 in respect of a bridge loan made by such party.  On February 11, 2016, the Company issued a promissory note to Platinum Partners Value Arbitrage Fund L.P. (“PPVA”) in the aggregate principal amount of $100,000 in respect of a bridge loan made by such party.  On March 21, 2016, the Company issued a promissory note to PPVA in the aggregate principal amount of $150,000 in respect of a bridge loan made by such party.  On April 4, 2016, the Company issued a promissory note to PPVA in the aggregate principal amount of $350,000 in respect of a bridge loan made by such party.  On April 18, 2016, the Company issued a promissory note to PPVA in the aggregate principal amount of $450,000 in respect of a bridge loan made by such party. On April 29, 2016, the Company issued a promissory note to BYT in the aggregate principal amount of $50,000 in respect of a bridge loan made by such party. These promissory notes, aggregating $1,400,000, which bore interest at the prime rate (or 3.5%), were exchanged for the May 3, 2016 second tranche financing of the Notes described below.   On April 14, 2016, the Company held a Special Meeting of Stockholders. Of the 11,124,496 shares of common stock outstanding and entitled to vote, 6,197,024 shares, or 56%, were represented at the meeting in person or by proxy. The stockholders approved the issuance by the Company of shares of its Common Stock pursuant to and in accordance with the terms of the private placement financing transaction contemplated by the Securities Purchase Agreement, dated January 29, 2016, by and among the Company and the investors named therein, and the other documents and agreements related thereto, and the other transactions contemplated thereby, including the amendment to Company's Certificate of Designations governing the terms of its Series F Convertible Preferred Stock as described therein, for purposes of complying with applicable Delaware law and NASDAQ Listing Rule 5635(d), as disclosed in the Company’s proxy statement.   On May 3, 2016, the Company closed the second tranche of the Note financing and issued Notes in an aggregate principal amount of $3,361,620, inclusive of $3,620 of interest due on bridge loans. In exchange for the Notes, the Company received $1,188,000 in gross cash proceeds, a note receivable, payable in 30 days and bearing interest at 12%, of $770,000, from BYT, and $1,400,000 of bridge notes were cancelled. The Company recorded a loss on early extinguishment of these bridge loans of $1,728,235, representing the excess value of the consideration consisting of the $1,400,000 secured convertible note, and a proportional amount of the Warrants totaling $510,348 and the embedded conversion feature of the Notes totaling $1,217,887, exchanged for certain bridge loans to cancel them. The Company incurred placement, legal and other fees aggregating $184,311 which were deducted from the gross cash proceeds. Additionally, the placement agent received Class B warrants, with a 1½ year term, to purchase 37,520 shares of the Company’s Common Stock at $1.50 per share. The Notes are initially convertible into 2,241,075 shares of Common Stock at $1.50 per share. The Company also issued Class B warrants, with a 1½ year term, to purchase 2,241,075 shares of Common Stock at $1.50 per share. The Company may call the Class B Warrants in the event that Company’s Common Stock is trading at 200% above the strike price for 10 consecutive trading days (at $100,000 value traded per day) if the Warrant is saleable into the public markets, provided that the holder will have the option of ten trading days to exercise. These Warrants, whose exercise price is subject to adjustments should the Company do a future financing at a price less than $1.50, are considered a derivative. The initial value of these derivative warrants was $1,245,943 which was determined utilizing a Monte Carlo Binomial Model. The assumptions utilized for these derivative warrants, as well as embedded conversion feature, described hereafter, are disclosed in Note 10. Additionally the Notes contain an embedded conversion feature which adjusts the conversion price should the Company have a price reset during the ninety days after April 29, 2016 (the effective date of the Company’s registration) or consummate a future financing at a price less than $1.50, and is also considered a derivative. A price reset to $0.91 occurred on July 29, 2016 as is further described below. The initial value of the embedded conversion feature within the Notes was $2,924,337 which was also determined utilizing a Monte Carlo Binomial Model.   In connection with the Note closing, the Certificate of Amendment to the Certificate of Designations of the Company’s Series F Convertible Preferred Stock was filed which provides the holders of 5,276,180 shares of the Company’s Series F Convertible Preferred Stock the same reset rights afforded the Note holders. This modification to the Series F provided them with a beneficial conversion feature. As a result of this change, the Company recorded a deemed dividend of $6,460,818.   Effective as of July 29, 2016, notice was given that the Conversion Price of the Notes issued to the note holders pursuant to the Securities Purchase Agreement, dated January 29, 2016 (the “Purchase Agreement”), between Echo Therapeutics, Inc. and the purchasers, had been reset from $1.50 per share to $0.91 per share. Additionally and also effective as of the same date, notice was given that, pursuant to Section 5(c)(v) of the Certification of Designation, Preferences and Rights of the Series F Convertible Preferred Stock of Echo Therapeutics, Inc. (the “Series F Designation”), the Conversion Ratio has been reset from 1:1 to 1:1.65. These resets were based on an amount equal to 80% of the average of the ten lowest closing prices of the Common Stock less than $1.50 per share during the ninety day period immediately following the effectiveness of the Registration Statement, as contemplated by Section 4(b) of the Notes. This price reset resulted in the Series F Convertible Preferred Stockholders receiving the right to 3,429,517 additional common shares upon conversion.   The Purchase Agreement for the above described Note financing contains customary representations, warranties and affirmative and negative covenants.  The Purchase Agreement also requires management and certain shareholders to lock-up certain of their shares for the earlier of six months after the effective date of a registration statement, the first anniversary of the initial closing (January 29, 2017), or the date, if applicable, such holder of securities is no longer an officer or directors of the Company, subject to certain exceptions.  In addition, for up to one year following the effective date of a registration statement, the Investors have the right to participate, on a pro rata basis, in certain subsequent financings by the Company, subject to certain limitations. In connection with the transaction, the Company entered into a registration rights agreement (the “Registration Rights Agreement”) that requires the Company to file one or more registration statements in respect of the shares of Common Stock underlying the Notes and Warrants. If the Company fails to make its filing deadlines or fails to maintain the registration statement for required periods of time, the Company will be subject to certain liquidated damages provisions. Newbridge Securities Corporation/Life Tech Capital (the “Placement Agent”) acted as the sole placement agent for the financing.     The Company may redeem the Notes at par when the Company stock price remains above $5.00 for ten consecutive days, or alternatively, at 125% of principal below $5.00. Interest is payable quarterly or, subject to receipt of stockholder approval, at the Company’s option, in shares of Common Stock.   The assumptions utilized for the embedded conversion feature valuation, which reflect the initial valuation at January 29th, May 3rd and subsequent valuation at September 30, 2016, were as follows:   <table cellspacing="0" cellpadding="0" style="font: 12pt Times New Roman, Times, Serif; width: 100%"> <tr style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="width: 89%">Risk-free interest rate %                                                                             </td> <td style="width: 11%; text-align: right">    0.34 – 0.48 </td></tr> <tr style="vertical-align: bottom; background-color: White"> <td style="text-align: justify">Expected dividend yield                                                                              </td> <td style="text-align: right">    — </td></tr> <tr style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="text-align: justify">Expected term - years (contractual term)                                                                              </td> <td style="text-align: right">    0.33 – 0.59 </td></tr> <tr style="vertical-align: bottom; background-color: White"> <td style="text-align: justify">Forfeiture rate                                                                              </td> <td style="text-align: right">    — </td></tr> <tr style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="text-align: justify">Expected volatility %                                                                              </td> <td style="text-align: right">    112 </td></tr> <tr style="vertical-align: bottom; background-color: White"> <td>Timing of down-round triggering event</td> <td style="text-align: right">   October 2016</td></tr> </table>   Follows is a summary of the Notes and related discounts and the Loss on the early extinguishment of bridge loans:   <table cellspacing="0" cellpadding="0" style="font: 12pt Times New Roman, Times, Serif; width: 100%"> <tr style="vertical-align: bottom"> <td> </td> <td style="padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: black 1pt solid; text-align: center">Original Value</td> <td style="padding-bottom: 1.5pt"> </td> <td style="padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: black 1pt solid"> Loss on Early Extinguishment of Bridge Loans</td> <td style="padding-bottom: 1.5pt"> </td> <td style="padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: black 1pt solid"> Secured Convertible Notes, net</td> <td style="padding-bottom: 1.5pt"> </td></tr> <tr style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="width: 64%">Cash and other proceeds received from financing </td> <td style="width: 1%"> </td> <td style="width: 1%"> </td> <td style="width: 9%; text-align: right">—</td> <td style="width: 1%"> </td> <td style="width: 1%"> </td> <td style="width: 1%"> </td> <td style="width: 9%; text-align: right">—</td> <td style="width: 1%"> </td> <td style="width: 1%"> </td> <td style="width: 1%">$</td> <td style="width: 9%; text-align: right">5,148,620</td> <td style="width: 1%"> </td></tr> <tr style="vertical-align: bottom; background-color: White"> <td>   Warrants </td> <td> </td> <td>$</td> <td style="text-align: right">2,147,574</td> <td> </td> <td> </td> <td> </td> <td style="text-align: right">(831,109</td> <td>)</td> <td> </td> <td> </td> <td style="text-align: right">(1,316,465</td> <td>)</td></tr> <tr style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td>   Embedded conversion feature in notes </td> <td> </td> <td>$</td> <td style="text-align: right">3,173,896</td> <td> </td> <td> </td> <td> </td> <td style="text-align: right">(1,312,851</td> <td>)</td> <td> </td> <td> </td> <td style="text-align: right">(1,861,045</td> <td>)</td></tr> <tr style="vertical-align: bottom; background-color: White"> <td>   Financing costs </td> <td> </td> <td> </td> <td style="text-align: right">—</td> <td> </td> <td> </td> <td> </td> <td style="text-align: right">—</td> <td> </td> <td> </td> <td> </td> <td style="text-align: right">(552,391</td> <td>)</td></tr> <tr style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td>   Amortization of debt discount </td> <td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: black 1pt solid"> </td> <td style="border-bottom: black 1pt solid; text-align: right">—</td> <td style="padding-bottom: 1.5pt"> </td> <td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: black 1pt solid"> </td> <td style="border-bottom: black 1pt solid; text-align: right">—</td> <td style="padding-bottom: 1.5pt"> </td> <td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: black 1pt solid"> </td> <td style="border-bottom: black 1pt solid; text-align: right">1,830,012</td> <td style="padding-bottom: 1.5pt"> </td></tr> <tr style="vertical-align: bottom; background-color: White"> <td>Totals, net </td> <td style="padding-bottom: 3pt"> </td> <td style="border-bottom: black 1.5pt double">$</td> <td style="border-bottom: black 1.5pt double; text-align: right">5,321,470</td> <td style="padding-bottom: 3pt"> </td> <td style="padding-bottom: 3pt"> </td> <td style="border-bottom: black 1.5pt double">$</td> <td style="border-bottom: black 1.5pt double; text-align: right">(2,143,960</td> <td style="padding-bottom: 3pt">)</td> <td style="padding-bottom: 3pt"> </td> <td style="border-bottom: black 1.5pt double">$</td> <td style="border-bottom: black 1.5pt double; text-align: right">3,248,731</td> <td style="padding-bottom: 3pt"> </td></tr> </table>   On September 23, 2016, the Company issued a promissory note to Network Victory Limited (“NVL”) in the aggregate principal amount of $250,000 in respect of a bridge loan made by such party. The promissory note, which bears interest at 18% per annum, may, at NVL’s option, be exchanged for securities issued in a subsequent financing by the Company.

In March 2003, the Company’s shareholders approved its 2003 Stock Option and Incentive Plan (the “2003 Plan”). Pursuant to the 2003 Plan, the Company’s Board of Directors (or its committees and/or executive officers delegated by the Board of Directors) may grant incentive and nonqualified stock options, restricted stock, and other stock-based awards to the Company’s employees, officers, directors, consultants and advisors. As of September 30, 2016, there were 5,000 restricted shares of Common Stock issued and options to purchase an aggregate of 26,500 shares of Common Stock outstanding under the 2003 Plan and no shares are available for future grants due to the 2003 Plan’s expiration.   In May 2008, the Company’s shareholders approved the 2008 Equity Compensation Plan, as amended (the “2008 Plan”). The 2008 Plan provides for grants of incentive stock options to employees and nonqualified stock options and restricted stock to employees, consultants and non-employee directors of the Company. The maximum number of shares available under the 2008 Plan is 10,000,000 shares. As of September 30, 2016, there were 288,866 restricted shares of Common Stock issued and options to purchase 2,403,565 shares of Common Stock outstanding under the 2008 Plan and 7,284,069 shares available for future grants.   The following table shows the remaining shares available for future grants for each plan and outstanding shares:   <table cellspacing="0" cellpadding="0" style="font: 12pt Times New Roman, Times, Serif; width: 100%"> <tr style="vertical-align: bottom"> <td> </td> <td style="padding-bottom: 1.5pt"> </td> <td colspan="6" style="border-bottom: black 1pt solid; text-align: center">Equity Compensation Plans</td> <td style="padding-bottom: 1.5pt"> </td> <td style="padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: black 1pt solid; text-align: center">Not Pursuant</td> <td style="padding-bottom: 1.5pt"> </td></tr> <tr style="vertical-align: bottom"> <td> </td> <td style="padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: black 1pt solid; text-align: center">2003 Plan</td> <td style="padding-bottom: 1.5pt"> </td> <td style="padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: black 1pt solid; text-align: center">2008 Plan</td> <td style="padding-bottom: 1.5pt"> </td> <td style="padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: black 1pt solid; text-align: center">to a Plan</td> <td style="padding-bottom: 1.5pt"> </td></tr> <tr style="vertical-align: bottom"> <td style="text-align: justify">Shares Available For Issuance</td> <td> </td> <td colspan="2" style="text-align: center"> </td> <td> </td> <td> </td> <td colspan="2" style="text-align: center"> </td> <td> </td> <td> </td> <td colspan="2" style="text-align: center"> </td> <td> </td></tr> <tr style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="text-align: justify">Total reserved for stock options and restricted stock </td> <td> </td> <td> </td> <td style="text-align: right">160,000</td> <td> </td> <td> </td> <td> </td> <td style="text-align: right">10,000,000</td> <td> </td> <td> </td> <td colspan="2" style="text-align: center"> </td> <td> </td></tr> <tr style="vertical-align: bottom; background-color: White"> <td>Net restricted stock issued net of cancellations </td> <td> </td> <td> </td> <td style="text-align: right">(5,000</td> <td>)</td> <td> </td> <td> </td> <td style="text-align: right">(288,866</td> <td>)</td> <td> </td> <td colspan="2" style="text-align: center"> </td> <td> </td></tr> <tr style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td>Stock options granted </td> <td> </td> <td> </td> <td style="text-align: right">(154,449</td> <td>)</td> <td> </td> <td> </td> <td style="text-align: right">(4,293,693</td> <td>)</td> <td> </td> <td colspan="2" style="text-align: center"> </td> <td> </td></tr> <tr style="vertical-align: bottom; background-color: White"> <td>Add back options cancelled before exercise </td> <td> </td> <td> </td> <td style="text-align: right">92,349</td> <td> </td> <td> </td> <td> </td> <td style="text-align: right">1,866,628</td> <td> </td> <td> </td> <td colspan="2" style="text-align: center"> </td> <td> </td></tr> <tr style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td>Less shares no longer available due to Plan expiration </td> <td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: black 1pt solid"> </td> <td style="border-bottom: black 1pt solid; text-align: right">(92,900</td> <td style="padding-bottom: 1.5pt">)</td> <td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: black 1pt solid"> </td> <td style="border-bottom: black 1pt solid; text-align: right">—</td> <td style="padding-bottom: 1.5pt"> </td> <td> </td> <td colspan="2" style="text-align: center"> </td> <td> </td></tr> <tr style="vertical-align: bottom; background-color: White"> <td style="text-align: justify">Remaining shares available for future grants at September 30, 2016</td> <td style="padding-bottom: 3pt"> </td> <td style="border-bottom: black 1.5pt double"> </td> <td style="border-bottom: black 1.5pt double; text-align: right">—</td> <td style="padding-bottom: 3pt"> </td> <td style="padding-bottom: 3pt"> </td> <td style="border-bottom: black 1.5pt double"> </td> <td style="border-bottom: black 1.5pt double; text-align: right">7,284,069</td> <td style="padding-bottom: 3pt"> </td> <td> </td> <td colspan="2" style="text-align: center"> </td> <td> </td></tr> <tr style="background-color: rgb(204,238,255)"> <td colspan="4" style="vertical-align: bottom"> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td></tr> <tr style="vertical-align: bottom; background-color: White"> <td style="width: 64%; text-align: justify">Stock options granted </td> <td style="width: 1%"> </td> <td style="width: 0%"> </td> <td style="width: 9%; text-align: right">154,449</td> <td style="width: 1%"> </td> <td style="width: 1%"> </td> <td style="width: 0%"> </td> <td style="width: 9%; text-align: right">4,293,693</td> <td> </td> <td style="width: 1%"> </td> <td style="width: 0%"> </td> <td style="width: 9%; text-align: right">310,000</td> <td style="width: 1%"> </td></tr> <tr style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td>Less:    Stock options cancelled</td> <td> </td> <td> </td> <td style="text-align: right">(92,349</td> <td>)</td> <td> </td> <td> </td> <td style="text-align: right">(1,866,628</td> <td>)</td> <td> </td> <td> </td> <td style="text-align: right">(243,333</td> <td>)</td></tr> <tr style="vertical-align: bottom; background-color: White"> <td>            Stock options exercised </td> <td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: black 1pt solid"> </td> <td style="border-bottom: black 1pt solid; text-align: right">(35,600</td> <td style="padding-bottom: 1.5pt">)</td> <td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: black 1pt solid"> </td> <td style="border-bottom: black 1pt solid; text-align: right">(23,500</td> <td style="padding-bottom: 1.5pt">)</td> <td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: black 1pt solid"> </td> <td style="border-bottom: black 1pt solid; text-align: right">(66,667</td> <td style="padding-bottom: 1.5pt">)</td></tr> <tr style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="text-align: justify">Net shares outstanding before restricted stock </td> <td> </td> <td> </td> <td style="text-align: right">26,500</td> <td> </td> <td> </td> <td> </td> <td style="text-align: right">2,403,565</td> <td> </td> <td> </td> <td> </td> <td style="text-align: right">—</td> <td> </td></tr> <tr style="vertical-align: bottom; background-color: White"> <td style="text-align: justify">Net restricted stock issued net of cancellations </td> <td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: black 1pt solid"> </td> <td style="border-bottom: black 1pt solid; text-align: right">5,000</td> <td style="padding-bottom: 1.5pt"> </td> <td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: black 1pt solid"> </td> <td style="border-bottom: black 1pt solid; text-align: right">288,866</td> <td style="padding-bottom: 1.5pt"> </td> <td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: black 1pt solid"> </td> <td style="border-bottom: black 1pt solid; text-align: right">6,485</td> <td style="padding-bottom: 1.5pt"> </td></tr> <tr style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="text-align: justify">Outstanding shares at September 30, 2016 </td> <td style="padding-bottom: 3pt"> </td> <td style="border-bottom: black 1.5pt double"> </td> <td style="border-bottom: black 1.5pt double; text-align: right">31,500</td> <td style="padding-bottom: 3pt"> </td> <td style="padding-bottom: 3pt"> </td> <td style="border-bottom: black 1.5pt double"> </td> <td style="border-bottom: black 1.5pt double; text-align: right">2,692,431</td> <td style="padding-bottom: 3pt"> </td> <td style="padding-bottom: 3pt"> </td> <td style="border-bottom: black 1.5pt double"> </td> <td style="border-bottom: black 1.5pt double; text-align: right">6,485</td> <td style="padding-bottom: 3pt"> </td></tr> </table>

The fair value of each stock option award is estimated on the date of grant using the Black-Scholes option pricing model with certain assumptions noted below. Expected volatilities are based on historical volatility of the Common Stock using historical periods consistent with the expected term of the options. The Company uses historical data, as well as subsequent events occurring prior to the issuance of the financial statements, to estimate option exercise and employee termination and forfeitures within the valuation model. The expected term of stock options granted under the Company’s stock plans is based on the average of the contractual term (generally 10 years) and the vesting period (generally 24 to 42 months). The risk-free rate is based on the yield of a U.S. Treasury security with a term consistent with the option.   For options issued and outstanding during the nine month periods ended September 30, 2016 and 2015, the Company recorded additional paid-in capital and non-cash compensation expense of $521,494 and $756,000, respectively, each net of estimated forfeitures.   The assumptions used principally for stock options granted to employees and members of the Company’s Board of Directors in the nine months ended September 30, 2016 and 2015 were as follows: <table cellspacing="0" cellpadding="0" style="font: 12pt Times New Roman, Times, Serif; width: 100%"> <tr style="vertical-align: bottom"> <td> </td> <td style="padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: black 1pt solid; text-align: center">2016</td> <td style="padding-bottom: 1.5pt"> </td> <td style="padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: black 1pt solid; text-align: center">2015</td> <td style="padding-bottom: 1.5pt"> </td></tr> <tr style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="width: 76%">Risk-free interest rate % </td> <td style="width: 1%"> </td> <td style="width: 1%"> </td> <td style="width: 9%; text-align: right">0.18 – 1.07</td> <td style="width: 1%"> </td> <td style="width: 1%"> </td> <td style="width: 1%"> </td> <td style="width: 9%; text-align: right">1.46 – 1.90</td> <td style="width: 1%"> </td></tr> <tr style="vertical-align: bottom; background-color: White"> <td>Expected dividend yield </td> <td> </td> <td> </td> <td style="text-align: right">—</td> <td> </td> <td> </td> <td> </td> <td style="text-align: right">—</td> <td> </td></tr> <tr style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td>Expected term - years </td> <td> </td> <td> </td> <td style="text-align: right">.25 – 4</td> <td> </td> <td> </td> <td> </td> <td style="text-align: right">5 – 5.5</td> <td> </td></tr> <tr style="vertical-align: bottom; background-color: White"> <td>Forfeiture rate % (excluding fully vested stock options) </td> <td> </td> <td> </td> <td style="text-align: right">2 – 5</td> <td> </td> <td> </td> <td> </td> <td style="text-align: right">7.5 - 15</td> <td> </td></tr> <tr style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td>Expected volatility % </td> <td> </td> <td> </td> <td style="text-align: right">0.94 – 1.28</td> <td> </td> <td> </td> <td> </td> <td style="text-align: right">0.92 – 0.93</td> <td> </td></tr> </table>   A summary of stock option activity for the nine months ended September 30, 2016 is as follows: <table cellspacing="0" cellpadding="0" style="font: 12pt Times New Roman, Times, Serif; width: 100%"> <tr style="vertical-align: bottom"> <td>         Stock Options</td> <td style="padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: black 1pt solid">         Shares</td> <td style="padding-bottom: 1.5pt"> </td> <td style="padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: black 1pt solid">   Weighted- Average Exercise Price</td> <td style="padding-bottom: 1.5pt"> </td> <td style="padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: black 1pt solid"> Weighted- Average Remaining Contractual Term (years)</td> <td style="padding-bottom: 1.5pt"> </td> <td style="padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: black 1pt solid">     Aggregate Intrinsic Value</td> <td style="padding-bottom: 1.5pt"> </td></tr> <tr style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td>Outstanding options at January 1, 2016 </td> <td> </td> <td> </td> <td style="text-align: right">1,667,233</td> <td> </td> <td> </td> <td>$</td> <td style="text-align: right">2.01</td> <td> </td> <td> </td> <td colspan="2" style="text-align: center"> </td> <td> </td> <td> </td> <td colspan="2" style="text-align: center"> </td> <td> </td></tr> <tr style="vertical-align: bottom; background-color: White"> <td>Granted </td> <td> </td> <td> </td> <td style="text-align: right">1,222,810</td> <td> </td> <td> </td> <td>$</td> <td style="text-align: right">1.28</td> <td> </td> <td> </td> <td colspan="2" style="text-align: center"> </td> <td> </td> <td> </td> <td colspan="2" style="text-align: center"> </td> <td> </td></tr> <tr style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td>Exercised </td> <td> </td> <td> </td> <td style="text-align: right">(10,500</td> <td>)</td> <td> </td> <td>$</td> <td style="text-align: right">1.19</td> <td> </td> <td> </td> <td colspan="2" style="text-align: center"> </td> <td> </td> <td> </td> <td colspan="2" style="text-align: center"> </td> <td> </td></tr> <tr style="vertical-align: bottom; background-color: White"> <td>Forfeited or expired </td> <td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: black 1pt solid"> </td> <td style="border-bottom: black 1pt solid; text-align: right">(449,478</td> <td style="padding-bottom: 1.5pt">)</td> <td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: black 1pt solid">$</td> <td style="border-bottom: black 1pt solid; text-align: right">2.47</td> <td style="padding-bottom: 1.5pt"> </td> <td style="padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: black 1pt solid; text-align: center"> </td> <td style="padding-bottom: 1.5pt"> </td> <td style="padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: black 1pt solid; text-align: center"> </td> <td style="padding-bottom: 1.5pt"> </td></tr> <tr style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="width: 52%">Outstanding options at September 30, 2016 </td> <td style="width: 1%; padding-bottom: 3pt"> </td> <td style="width: 1%; border-bottom: black 1.5pt double"> </td> <td style="width: 9%; border-bottom: black 1.5pt double; text-align: right">2,430,065</td> <td style="width: 1%; padding-bottom: 3pt"> </td> <td style="width: 1%; padding-bottom: 3pt"> </td> <td style="width: 1%; border-bottom: black 1.5pt double">$</td> <td style="width: 9%; border-bottom: black 1.5pt double; text-align: right">1.56</td> <td style="width: 1%; padding-bottom: 3pt"> </td> <td style="width: 1%; padding-bottom: 3pt"> </td> <td style="width: 1%; border-bottom: black 1.5pt double"> </td> <td style="width: 9%; border-bottom: black 1.5pt double; text-align: right">8.63</td> <td style="width: 1%; padding-bottom: 3pt"> </td> <td style="width: 1%; padding-bottom: 3pt"> </td> <td style="width: 1%; border-bottom: black 1.5pt double">$</td> <td style="width: 9%; border-bottom: black 1.5pt double; text-align: right">—</td> <td style="width: 1%; padding-bottom: 3pt"> </td></tr> <tr style="vertical-align: bottom; background-color: White"> <td>Exercisable options at September 30, 2016 </td> <td style="padding-bottom: 3pt"> </td> <td style="border-bottom: black 1.5pt double"> </td> <td style="border-bottom: black 1.5pt double; text-align: right">1,622,072</td> <td style="padding-bottom: 3pt"> </td> <td style="padding-bottom: 3pt"> </td> <td style="border-bottom: black 1.5pt double">$</td> <td style="border-bottom: black 1.5pt double; text-align: right">1.59</td> <td style="padding-bottom: 3pt"> </td> <td style="padding-bottom: 3pt"> </td> <td style="border-bottom: black 1.5pt double"> </td> <td style="border-bottom: black 1.5pt double; text-align: right">8.48</td> <td style="padding-bottom: 3pt"> </td> <td style="padding-bottom: 3pt"> </td> <td style="border-bottom: black 1.5pt double">$</td> <td style="border-bottom: black 1.5pt double; text-align: right">—</td> <td style="padding-bottom: 3pt"> </td></tr> </table>   The weighted-average grant-date fair value of stock options granted for the nine months period ended September 30, 2016 was $1.28 per share. As of September 30, 2016, there was $435,072 of total unrecognized compensation expense related to non-vested share-based option compensation arrangements. With the exception of the unrecognized share-based compensation related to certain restricted stock grants to officers and employees that contain performance conditions related to FDA approval for the Company’s CGM system or the sale of substantially all of the stock or assets of the Company, unrecognized compensation is expected to be recognized over the next four years.

For restricted stock issued and outstanding during the nine months ended September 30, 2016 and 2015, the Company incurred non-cash compensation expense of $181,369 and $42,000, respectively, each net of estimated forfeitures.   During the nine months ended September 30, 2016, the Company granted 280,000 restricted shares of Common Stock to its officers and Vice President of Operations and Product Development of the Company, in connection with their respective salary deferrals.   A summary of non-vested restricted stock activity for the nine months ended September 30, 2016 is as follows:   <table cellspacing="0" cellpadding="0" style="font: 12pt Times New Roman, Times, Serif; width: 100%"> <tr style="vertical-align: bottom"> <td>Restricted Stock</td> <td style="padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: black 1pt solid">       Shares</td> <td style="padding-bottom: 1.5pt"> </td> <td style="padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: black 1pt solid"> Weighted- Average Grant-Date Fair Value</td> <td style="padding-bottom: 1.5pt"> </td></tr> <tr style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="width: 76%">Non-vested shares at January 1, 2016 </td> <td style="width: 1%"> </td> <td style="width: 1%"> </td> <td style="width: 9%; text-align: right">27,842</td> <td style="width: 1%"> </td> <td style="width: 1%"> </td> <td style="width: 1%">$</td> <td style="width: 9%; text-align: right">13.06</td> <td style="width: 1%"> </td></tr> <tr style="vertical-align: bottom; background-color: White"> <td>Granted </td> <td> </td> <td> </td> <td style="text-align: right">280,000</td> <td> </td> <td> </td> <td>$</td> <td style="text-align: right">1.13</td> <td> </td></tr> <tr style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td>Vested </td> <td> </td> <td> </td> <td style="text-align: right">(2,020</td> <td>)</td> <td> </td> <td>$</td> <td style="text-align: right">8.68</td> <td> </td></tr> <tr style="vertical-align: bottom; background-color: White"> <td>Forfeited </td> <td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: black 1pt solid"> </td> <td style="border-bottom: black 1pt solid; text-align: right">(5,471</td> <td style="padding-bottom: 1.5pt">)</td> <td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: black 1pt solid">$</td> <td style="border-bottom: black 1pt solid; text-align: right">7.67</td> <td style="padding-bottom: 1.5pt"> </td></tr> <tr style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td>Non-vested shares at September 30, 2016 </td> <td style="padding-bottom: 3pt"> </td> <td style="border-bottom: black 1.5pt double"> </td> <td style="border-bottom: black 1.5pt double; text-align: right">300,351</td> <td style="padding-bottom: 3pt"> </td> <td style="padding-bottom: 3pt"> </td> <td style="border-bottom: black 1.5pt double">$</td> <td style="border-bottom: black 1.5pt double; text-align: right">2.07</td> <td style="padding-bottom: 3pt"> </td></tr> </table>   Among the 300,351 shares of non-vested restricted stock, the various vesting criteria include the following:   <table cellpadding="0" style="width: 100%; font: 12pt Times New Roman, Times, Serif"> <tr> <td style="vertical-align: top; padding: 0.75pt">●</td> <td colspan="2" style="padding: 0.75pt; text-align: justify">14,185 shares of restricted stock vest upon the FDA approval of the Company’s CGM system or the sale of the Company; and</td></tr> <tr> <td style="vertical-align: top; padding: 0.75pt">●</td> <td style="padding: 0.75pt; text-align: justify">6,166 shares of restricted stock vest over 4 years, at each of the anniversary dates of the grants, and</td></tr> </table>   <table cellpadding="0" style="width: 100%; font: 12pt Times New Roman, Times, Serif"> <tr> <td style="vertical-align: top; padding: 0.75pt">●</td> <td style="padding: 0.75pt; text-align: justify">130,000 shares of restricted stock vest 18 months from the date of issuance, and</td></tr> <tr> <td style="vertical-align: top; padding: 0.75pt">●</td> <td colspan="2" style="padding: 0.75pt; text-align: justify">150,000 shares of restricted stock vest quarterly after the company receives debt/equity financing of at least $1 million</td></tr> </table>   As of September 30, 2016, there was $438,429 of total unrecognized compensation expense related to non-vested share-based restricted stock arrangements granted pursuant to the Company’s equity compensation plans that vest over time in the foreseeable future. As of September 30, 2016, the Company cannot estimate the timing of completion of performance vesting requirements required by certain of these restricted stock grant arrangements. Compensation expense related to these restricted share grants will be recognized when the Company concludes that achievement of the performance vesting conditions is probable. In the nine months ended September 30, 2016, the Company issued warrants to purchase 3,552,875 shares of the Company’s common stock in connection with its Note financing. See Note 5.   A summary of warrant activity for the nine months ended September 30, 2016 is as follows: <table cellspacing="0" cellpadding="0" style="font: 12pt Times New Roman, Times, Serif; width: 100%"> <tr style="vertical-align: bottom"> <td>       Warrants</td> <td style="padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: black 1pt solid">       Shares</td> <td style="padding-bottom: 1.5pt"> </td> <td style="padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: black 1pt solid"> Weighted- Average Exercise Price</td> <td style="padding-bottom: 1.5pt"> </td></tr> <tr style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="width: 76%; text-align: justify">Outstanding warrants at January 1, 2016 </td> <td style="width: 1%"> </td> <td style="width: 1%"> </td> <td style="width: 9%; text-align: right">4,530,428</td> <td style="width: 1%"> </td> <td style="width: 1%"> </td> <td style="width: 1%">$</td> <td style="width: 9%; text-align: right">3.68</td> <td style="width: 1%"> </td></tr> <tr style="vertical-align: bottom; background-color: White"> <td style="text-align: justify">Granted </td> <td> </td> <td> </td> <td style="text-align: right">3,552,875</td> <td> </td> <td> </td> <td>$</td> <td style="text-align: right">1.50</td> <td> </td></tr> <tr style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="text-align: justify">Forfeited </td> <td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: black 1pt solid"> </td> <td style="border-bottom: black 1pt solid; text-align: right">—</td> <td style="padding-bottom: 1.5pt"> </td> <td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: black 1pt solid">$</td> <td style="border-bottom: black 1pt solid; text-align: right">—</td> <td style="padding-bottom: 1.5pt"> </td></tr> <tr style="vertical-align: bottom; background-color: White"> <td style="text-align: justify">Outstanding warrants at September 30, 2016 </td> <td style="padding-bottom: 3pt"> </td> <td style="border-bottom: black 1.5pt double"> </td> <td style="border-bottom: black 1.5pt double; text-align: right">8,083,303</td> <td style="padding-bottom: 3pt"> </td> <td style="padding-bottom: 3pt"> </td> <td style="border-bottom: black 1.5pt double">$</td> <td style="border-bottom: black 1.5pt double; text-align: right">2.72</td> <td style="padding-bottom: 3pt"> </td></tr> </table>   At September 30, 2016, the Company had the following outstanding warrants: <table cellpadding="0" cellspacing="0" style="border-collapse: collapse; width: 100%; font: 12pt Times New Roman, Times, Serif"> <tr style="vertical-align: bottom"> <td>Type of Warrant/Range of Exercise Prices</td><td> </td> <td colspan="3"> </td><td> </td> <td colspan="3"> </td><td> </td> <td colspan="3" style="text-align: center">Expirations</td><td> </td> <td colspan="3" style="text-align: center">Number Outstanding</td><td> </td> <td colspan="3" style="text-align: center">Weighted-Average RemainingContractual Life (years)</td><td> </td> <td colspan="3" style="text-align: center">Weighted- Average Exercise Price</td><td> </td> <td>Number Exercisable</td></tr> <tr style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="font-size: 8pt"> Derivative:</td><td> </td> <td style="text-align: left"> </td><td style="text-align: right"> </td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td style="text-align: right"> </td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td style="text-align: right"> </td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td style="text-align: right"> </td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td style="text-align: right"> </td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td style="text-align: right"> </td><td style="text-align: left"> </td></tr> <tr style="vertical-align: bottom; background-color: White"> <td style="width: 22%"> </td><td style="width: 1%; font-size: 8pt"> </td> <td style="width: 1%; font-size: 8pt; text-align: left"> </td><td style="width: 10%; font-size: 8pt; text-align: right"> </td><td style="width: 1%; font-size: 8pt; text-align: left"> </td><td style="width: 1%; font-size: 8pt"> </td> <td style="width: 1%; font-size: 8pt; text-align: left">$</td><td style="width: 10%; font-size: 8pt; text-align: right">1.50</td><td style="width: 1%; font-size: 8pt; text-align: left"> </td><td style="width: 1%; font-size: 8pt"> </td> <td style="width: 1%; font-size: 8pt; text-align: left"> </td><td style="width: 10%; font-size: 8pt; text-align: right">7/29/21</td><td style="width: 1%; font-size: 8pt; text-align: left"> </td><td style="width: 1%; font-size: 8pt"> </td> <td style="width: 1%; font-size: 8pt; text-align: left"> </td><td style="width: 10%; font-size: 8pt; text-align: right">1,274,280</td><td style="width: 1%; font-size: 8pt; text-align: left"> </td><td style="width: 1%; font-size: 8pt"> </td> <td style="width: 1%; font-size: 8pt; text-align: left"> </td><td style="width: 10%; font-size: 8pt; text-align: right">4.83</td><td style="width: 1%; font-size: 8pt; text-align: left"> </td><td style="width: 1%; font-size: 8pt"> </td> <td style="width: 1%; font-size: 8pt; text-align: left">$</td><td style="width: 10%; font-size: 8pt; text-align: right">1.50</td><td style="width: 1%; font-size: 8pt; text-align: left"> </td><td style="width: 1%; font-size: 8pt"> </td> <td style="font-size: 8pt; text-align: right">1,274,280</td></tr> <tr style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td> </td><td style="font-size: 8pt"> </td> <td style="font-size: 8pt; text-align: left"> </td><td style="font-size: 8pt; text-align: right"> </td><td style="font-size: 8pt; text-align: left"> </td><td style="font-size: 8pt"> </td> <td style="font-size: 8pt; text-align: left">$</td><td style="font-size: 8pt; text-align: right">1.50</td><td style="font-size: 8pt; text-align: left"> </td><td style="font-size: 8pt"> </td> <td style="font-size: 8pt; text-align: left"> </td><td style="font-size: 8pt; text-align: right">5/3/18</td><td style="font-size: 8pt; text-align: left"> </td><td style="font-size: 8pt"> </td> <td style="font-size: 8pt; text-align: left"> </td><td style="font-size: 8pt; text-align: right">2,278,595</td><td style="font-size: 8pt; text-align: left"> </td><td style="font-size: 8pt"> </td> <td style="font-size: 8pt; text-align: left"> </td><td style="font-size: 8pt; text-align: right">1.59</td><td style="font-size: 8pt; text-align: left"> </td><td style="font-size: 8pt"> </td> <td style="font-size: 8pt; text-align: left">$</td><td style="font-size: 8pt; text-align: right">1.50</td><td style="font-size: 8pt; text-align: left"> </td><td style="font-size: 8pt"> </td> <td style="font-size: 8pt; text-align: right">2,278,595</td></tr> <tr style="vertical-align: bottom; background-color: White"> <td> </td><td style="font-size: 8pt"> </td> <td style="font-size: 8pt; text-align: left"> </td><td style="font-size: 8pt; text-align: right"> </td><td style="font-size: 8pt; text-align: left"> </td><td style="font-size: 8pt"> </td> <td style="font-size: 8pt; text-align: left">$</td><td style="font-size: 8pt; text-align: right">7.50</td><td style="font-size: 8pt; text-align: left"> </td><td style="font-size: 8pt"> </td> <td style="font-size: 8pt; text-align: left"> </td><td style="font-size: 8pt; text-align: right">8/31/17 to 11/6/17</td><td style="font-size: 8pt; text-align: left"> </td><td style="font-size: 8pt"> </td> <td style="font-size: 8pt; text-align: left"> </td><td style="font-size: 8pt; text-align: right">700,000</td><td style="font-size: 8pt; text-align: left"> </td><td style="font-size: 8pt"> </td> <td style="font-size: 8pt; text-align: left"> </td><td style="font-size: 8pt; text-align: right">0.97</td><td style="font-size: 8pt; text-align: left"> </td><td style="font-size: 8pt"> </td> <td style="font-size: 8pt; text-align: left">$</td><td style="font-size: 8pt; text-align: right">7.50</td><td style="font-size: 8pt; text-align: left"> </td><td style="font-size: 8pt"> </td> <td style="font-size: 8pt; text-align: right">700,000</td></tr> <tr style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="font-size: 8pt">Equity:</td><td> </td> <td style="text-align: left"> </td><td style="text-align: right"> </td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td style="text-align: right"> </td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td style="text-align: right"> </td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td style="text-align: right"> </td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td style="text-align: right"> </td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td style="text-align: right"> </td><td style="text-align: left"> </td></tr> <tr style="vertical-align: bottom; background-color: White"> <td style="padding-bottom: 1pt"> </td><td style="font-size: 8pt; padding-bottom: 1pt"> </td> <td style="border-bottom: Black 1pt solid; font-size: 8pt; text-align: left"> </td><td style="border-bottom: Black 1pt solid; font-size: 8pt; text-align: right">$</td><td style="padding-bottom: 1pt; font-size: 8pt; text-align: left"> </td><td style="font-size: 8pt; padding-bottom: 1pt"> </td> <td style="border-bottom: Black 1pt solid; font-size: 8pt; text-align: left"> </td><td style="border-bottom: Black 1pt solid; font-size: 8pt; text-align: right">2.75 - $3.00</td><td style="padding-bottom: 1pt; font-size: 8pt; text-align: left"> </td><td style="font-size: 8pt; padding-bottom: 1pt"> </td> <td style="border-bottom: Black 1pt solid; font-size: 8pt; text-align: left"> </td><td style="border-bottom: Black 1pt solid; font-size: 8pt; text-align: right">12/10/18 to 10//30/20</td><td style="padding-bottom: 1pt; font-size: 8pt; text-align: left"> </td><td style="font-size: 8pt; padding-bottom: 1pt"> </td> <td style="border-bottom: Black 1pt solid; font-size: 8pt; text-align: left"> </td><td style="border-bottom: Black 1pt solid; font-size: 8pt; text-align: right">3,830,428</td><td style="padding-bottom: 1pt; font-size: 8pt; text-align: left"> </td><td style="font-size: 8pt; padding-bottom: 1pt"> </td> <td style="border-bottom: Black 1pt solid; font-size: 8pt; text-align: left"> </td><td style="border-bottom: Black 1pt solid; font-size: 8pt; text-align: right">3.44</td><td style="padding-bottom: 1pt; font-size: 8pt; text-align: left"> </td><td style="font-size: 8pt; padding-bottom: 1pt"> </td> <td style="border-bottom: Black 1pt solid; font-size: 8pt; text-align: left">$</td><td style="border-bottom: Black 1pt solid; font-size: 8pt; text-align: right">2.98</td><td style="padding-bottom: 1pt; font-size: 8pt; text-align: left"> </td><td style="font-size: 8pt; padding-bottom: 1pt"> </td> <td style="border-bottom: Black 1pt solid; font-size: 8pt; text-align: right">3,830,428</td></tr> <tr style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="font-size: 8pt; text-align: left; padding-bottom: 2.5pt">Total outstanding</td><td style="padding-bottom: 2.5pt"> </td> <td style="border-bottom: Black 2.5pt double; text-align: left"> </td><td style="border-bottom: Black 2.5pt double; text-align: right"> </td><td style="padding-bottom: 2.5pt; text-align: left"> </td><td style="padding-bottom: 2.5pt"> </td> <td style="border-bottom: Black 2.5pt double; text-align: left"> </td><td style="border-bottom: Black 2.5pt double; text-align: right"> </td><td style="padding-bottom: 2.5pt; text-align: left"> </td><td style="font-size: 8pt; padding-bottom: 2.5pt"> </td> <td style="border-bottom: Black 2.5pt double; font-size: 8pt; text-align: left"> </td><td style="border-bottom: Black 2.5pt double; font-size: 8pt; text-align: right">8,083,303</td><td style="padding-bottom: 2.5pt; font-size: 8pt; text-align: left"> </td><td style="padding-bottom: 2.5pt"> </td> <td style="border-bottom: Black 2.5pt double; text-align: left"> </td><td style="border-bottom: Black 2.5pt double; text-align: right"> </td><td style="padding-bottom: 2.5pt; text-align: left"> </td><td style="padding-bottom: 2.5pt"> </td> <td style="border-bottom: Black 2.5pt double; text-align: left"> </td><td style="border-bottom: Black 2.5pt double; text-align: right"> </td><td style="padding-bottom: 2.5pt; text-align: left"> </td><td style="padding-bottom: 2.5pt"> </td> <td style="border-bottom: Black 2.5pt double; text-align: left"> </td><td style="border-bottom: Black 2.5pt double; text-align: right"> </td><td style="padding-bottom: 2.5pt; text-align: left"> </td><td style="font-size: 8pt; padding-bottom: 2.5pt"> </td> <td style="border-bottom: Black 2.5pt double; font-size: 8pt; text-align: right">8,083,303</td></tr> </table>     The Company uses valuation methods and assumptions that consider among other factors the fair value of the underlying stock, risk-free interest rate, volatility, expected life and dividend rates in estimating fair value for the warrants considered to be derivative instruments.   The following assumptions were utilized by the Company: <table cellspacing="0" cellpadding="0" style="font: 12pt Times New Roman, Times, Serif; width: 100%"> <tr style="vertical-align: bottom"> <td>   By expiration:</td> <td style="padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: black 1pt solid">   7/29/21</td> <td style="padding-bottom: 1.5pt"> </td> <td style="padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: black 1pt solid">   5/3/18</td> <td style="padding-bottom: 1.5pt"> </td> <td style="padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: black 1pt solid; text-align: center">8/31/17 - 11/6/17</td> <td style="padding-bottom: 1.5pt"> </td></tr> <tr style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="width: 64%; text-align: justify">Risk-free interest rate % </td> <td> </td> <td> </td> <td style="width: 9%; text-align: right">1.03</td> <td style="width: 1%"> </td> <td style="width: 1%"> </td> <td> </td> <td style="text-align: right">0.56</td> <td> </td> <td style="width: 1%"> </td> <td style="width: 0%"> </td> <td style="width: 9%; text-align: right">0.73</td> <td style="width: 1%"> </td></tr> <tr style="vertical-align: bottom; background-color: White"> <td style="text-align: justify">Expected dividend yield </td> <td> </td> <td> </td> <td style="text-align: right">—</td> <td> </td> <td> </td> <td> </td> <td style="text-align: right">—</td> <td> </td> <td> </td> <td> </td> <td style="text-align: right">—</td> <td> </td></tr> <tr style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="text-align: justify">Expected term - years (contractual term) </td> <td> </td> <td> </td> <td style="text-align: right">5.15</td> <td> </td> <td> </td> <td> </td> <td style="text-align: right">1.87</td> <td> </td> <td> </td> <td> </td> <td style="text-align: right">1.17 - 1.35</td> <td> </td></tr> <tr style="vertical-align: bottom; background-color: White"> <td style="text-align: justify">Forfeiture rate </td> <td> </td> <td> </td> <td style="text-align: right">—</td> <td> </td> <td> </td> <td> </td> <td style="text-align: right">—</td> <td> </td> <td> </td> <td> </td> <td style="text-align: right">—</td> <td> </td></tr> <tr style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="text-align: justify">Expected volatility % </td> <td> </td> <td> </td> <td style="text-align: right">103</td> <td> </td> <td> </td> <td> </td> <td style="text-align: right">103</td> <td> </td> <td> </td> <td> </td> <td style="text-align: right">84.95</td> <td> </td></tr> <tr style="background-color: White"> <td style="vertical-align: bottom; text-align: justify">Timing of down-round triggering event </td> <td style="vertical-align: bottom">    </td> <td style="vertical-align: bottom"> </td> <td colspan="2" style="vertical-align: bottom; text-align: right">August 2016</td> <td style="vertical-align: bottom"> </td> <td style="vertical-align: bottom"> </td> <td style="vertical-align: bottom"> </td> <td style="vertical-align: bottom; text-align: right">N/A</td> <td style="vertical-align: bottom"> </td> <td> </td> <td> </td> <td> </td></tr> </table>     Expected volatilities are based on historical volatility of the Common Stock using historical periods consistent with the expected term of the warrant. The risk-free rate is based on the yield of a U.S. Treasury security with a term consistent with the warrant.

From time to time, the Company is subject to legal proceedings, claims, investigations, and proceedings in the ordinary course of business. In accordance with generally accepted accounting principles, the Company makes a provision for a liability when it is both probable that a liability has been incurred and the amount of the loss or range of loss can be reasonably estimated. These provisions, if any, are reviewed at least quarterly and adjusted to reflect the impacts of negotiations, settlements, rulings, advice of legal counsel, and other information and events pertaining to a particular case. Litigation is inherently unpredictable. At September 30, 2016, no litigation loss is deemed probable or reasonably estimated.   On September 23, 2016, Scott W. Hollander, President and Chief Executive Officer and a director of the Company, and the Company entered into a separation agreement (the “Separation Agreement”) pursuant to which the parties mutually agreed to Mr. Hollander’s separation from the Company, effective September 23, 2016 (the “Separation Date”). Under the Separation Agreement, Mr. Hollander will receive: (i) severance pay equal to the gross amount of $420,000 (the “Severance Amount”), less applicable federal, state and local withholding and taxes, payable in monthly amounts of $17,500 commencing on October 15, 2016, subject to increase to $25,000 per month if the Company shall consummate a debt or equity financing as described in Section 3(a)(ii) of the Severance Agreement, until the Severance Amount is fully paid; (ii) 150,000 shares of restricted stock previously awarded in March 2016 pursuant to a restricted stock agreement shall vest in quarterly installments of 37,500 shares; (iii) accelerated vesting of all unvested stock options previously awarded to him in December 2014 and March 2016 with three (3) months from the Separation Date to exercise such options; and (iv) reimbursement of COBRA payments for up to eighteen (18) months.

On October 19, 2016, the Company issued a promissory note to Network Victory Limited in the aggregate principal amount of $125,000 in respect of a bridge loan made by such party. The promissory note, which bears interest at 18% per annum, may, at NVL’s option, be exchanged for securities issued in a subsequent financing by the Company.   On October 28, 2016, the Company issued stock options to its employees and a certain consultant aggregating 131,155 shares to purchase our common stock at $0.45 per share. These options vest in one year.

<table cellspacing="0" cellpadding="0" style="font: 12pt Times New Roman, Times, Serif; width: 100%"> <tr style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="width: 89%">Risk-free interest rate %                                                                             </td> <td style="width: 11%; text-align: right">    0.34 – 0.48 </td></tr> <tr style="vertical-align: bottom; background-color: White"> <td style="text-align: justify">Expected dividend yield                                                                              </td> <td style="text-align: right">    — </td></tr> <tr style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="text-align: justify">Expected term - years (contractual term)                                                                              </td> <td style="text-align: right">    0.33 – 0.59 </td></tr> <tr style="vertical-align: bottom; background-color: White"> <td style="text-align: justify">Forfeiture rate                                                                              </td> <td style="text-align: right">    — </td></tr> <tr style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="text-align: justify">Expected volatility %                                                                              </td> <td style="text-align: right">    112 </td></tr> <tr style="vertical-align: bottom; background-color: White"> <td>Timing of down-round triggering event</td> <td style="text-align: right">   October 2016</td></tr> </table>

<table cellpadding="0" cellspacing="0" style="border-collapse: collapse; width: 100%; font: 12pt Times New Roman, Times, Serif"> <tr style="vertical-align: bottom"> <td> </td><td style="font-size: 8pt; font-weight: bold; padding-bottom: 1pt"> </td> <td colspan="3" style="font-size: 8pt; font-weight: bold; text-align: center; border-bottom: Black 1pt solid">Original Value</td><td style="font-size: 8pt; padding-bottom: 1pt"> </td> <td colspan="3" style="font-size: 8pt; text-align: center; border-bottom: Black 1pt solid">Loss on Early Extinguishment of Bridge Loans</td><td style="font-size: 8pt; padding-bottom: 1pt"> </td> <td colspan="3" style="font-size: 8pt; text-align: center; border-bottom: Black 1pt solid">Secured Convertible Notes, net</td></tr> <tr style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="width: 61%; font-size: 8pt; text-align: left">Cash and other proceeds received from financing</td><td style="width: 1%; font-size: 8pt"> </td> <td style="width: 1%; font-size: 8pt; text-align: left"> </td><td style="width: 10%; font-size: 8pt; text-align: right">—  </td><td style="width: 1%; font-size: 8pt; text-align: left"> </td><td style="width: 1%; font-size: 8pt"> </td> <td style="width: 1%; font-size: 8pt; text-align: left"> </td><td style="width: 10%; font-size: 8pt; text-align: right">—  </td><td style="width: 1%; font-size: 8pt; text-align: left"> </td><td style="width: 1%; font-size: 8pt"> </td> <td style="width: 1%; font-size: 8pt; text-align: left">$</td><td style="width: 10%; font-size: 8pt; text-align: right">5,148,620</td><td style="width: 1%; font-size: 8pt; text-align: left"> </td></tr> <tr style="vertical-align: bottom; background-color: White"> <td style="font-size: 8pt">  Warrants</td><td style="font-size: 8pt"> </td> <td style="font-size: 8pt; text-align: left">$</td><td style="font-size: 8pt; text-align: right">2,147,574</td><td style="font-size: 8pt; text-align: left"> </td><td style="font-size: 8pt"> </td> <td style="font-size: 8pt; text-align: left"> </td><td style="font-size: 8pt; text-align: right">(831,109</td><td style="font-size: 8pt; text-align: left">)</td><td style="font-size: 8pt"> </td> <td style="font-size: 8pt; text-align: left"> </td><td style="font-size: 8pt; text-align: right">(1,316,465</td><td style="font-size: 8pt; text-align: left">)</td></tr> <tr style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="font-size: 8pt; text-align: left">  Embedded conversion feature in notes</td><td style="font-size: 8pt"> </td> <td style="font-size: 8pt; text-align: left">$</td><td style="font-size: 8pt; text-align: right">3,173,896</td><td style="font-size: 8pt; text-align: left"> </td><td style="font-size: 8pt"> </td> <td style="font-size: 8pt; text-align: left"> </td><td style="font-size: 8pt; text-align: right">(1,312,851</td><td style="font-size: 8pt; text-align: left">)</td><td style="font-size: 8pt"> </td> <td style="font-size: 8pt; text-align: left"> </td><td style="font-size: 8pt; text-align: right">(1,861,045</td><td style="font-size: 8pt; text-align: left">)</td></tr> <tr style="vertical-align: bottom; background-color: White"> <td style="font-size: 8pt; text-align: left">  Financing costs</td><td style="font-size: 8pt"> </td> <td style="font-size: 8pt; text-align: left"> </td><td style="font-size: 8pt; text-align: right">—  </td><td style="font-size: 8pt; text-align: left"> </td><td style="font-size: 8pt"> </td> <td style="font-size: 8pt; text-align: left"> </td><td style="font-size: 8pt; text-align: right">—  </td><td style="font-size: 8pt; text-align: left"> </td><td style="font-size: 8pt"> </td> <td style="font-size: 8pt; text-align: left"> </td><td style="font-size: 8pt; text-align: right">(552,391</td><td style="font-size: 8pt; text-align: left">)</td></tr> <tr style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="font-size: 8pt; text-align: left; padding-bottom: 1pt">  Amortization of debt discount</td><td style="font-size: 8pt; padding-bottom: 1pt"> </td> <td style="border-bottom: Black 1pt solid; font-size: 8pt; text-align: left"> </td><td style="border-bottom: Black 1pt solid; font-size: 8pt; text-align: right">—  </td><td style="padding-bottom: 1pt; font-size: 8pt; text-align: left"> </td><td style="font-size: 8pt; padding-bottom: 1pt"> </td> <td style="border-bottom: Black 1pt solid; font-size: 8pt; text-align: left"> </td><td style="border-bottom: Black 1pt solid; font-size: 8pt; text-align: right">—  </td><td style="padding-bottom: 1pt; font-size: 8pt; text-align: left"> </td><td style="font-size: 8pt; padding-bottom: 1pt"> </td> <td style="border-bottom: Black 1pt solid; font-size: 8pt; text-align: left"> </td><td style="border-bottom: Black 1pt solid; font-size: 8pt; text-align: right">1,830,012</td><td style="padding-bottom: 1pt; font-size: 8pt; text-align: left"> </td></tr> <tr style="vertical-align: bottom; background-color: White"> <td style="font-size: 8pt; text-align: left; padding-bottom: 2.5pt">Totals, net</td><td style="font-size: 8pt; padding-bottom: 2.5pt"> </td> <td style="border-bottom: Black 2.5pt double; font-size: 8pt; text-align: left">$</td><td style="border-bottom: Black 2.5pt double; font-size: 8pt; text-align: right">5,321,470</td><td style="padding-bottom: 2.5pt; font-size: 8pt; text-align: left"> </td><td style="font-size: 8pt; padding-bottom: 2.5pt"> </td> <td style="border-bottom: Black 2.5pt double; font-size: 8pt; text-align: left">$</td><td style="border-bottom: Black 2.5pt double; font-size: 8pt; text-align: right">(2,143,960</td><td style="padding-bottom: 2.5pt; font-size: 8pt; text-align: left">)</td><td style="font-size: 8pt; padding-bottom: 2.5pt"> </td> <td style="border-bottom: Black 2.5pt double; font-size: 8pt; text-align: left">$</td><td style="border-bottom: Black 2.5pt double; font-size: 8pt; text-align: right">3,248,731</td><td style="padding-bottom: 2.5pt; font-size: 8pt; text-align: left"> </td></tr> </table>

<table cellspacing="0" cellpadding="0" style="font: 12pt Times New Roman, Times, Serif; width: 100%"> <tr style="vertical-align: bottom"> <td> </td> <td style="padding-bottom: 1.5pt"> </td> <td colspan="6" style="border-bottom: black 1pt solid; text-align: center">Equity Compensation Plans</td> <td style="padding-bottom: 1.5pt"> </td> <td style="padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: black 1pt solid; text-align: center">Not Pursuant</td> <td style="padding-bottom: 1.5pt"> </td></tr> <tr style="vertical-align: bottom"> <td> </td> <td style="padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: black 1pt solid; text-align: center">2003 Plan</td> <td style="padding-bottom: 1.5pt"> </td> <td style="padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: black 1pt solid; text-align: center">2008 Plan</td> <td style="padding-bottom: 1.5pt"> </td> <td style="padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: black 1pt solid; text-align: center">to a Plan</td> <td style="padding-bottom: 1.5pt"> </td></tr> <tr style="vertical-align: bottom"> <td style="text-align: justify">Shares Available For Issuance</td> <td> </td> <td colspan="2" style="text-align: center"> </td> <td> </td> <td> </td> <td colspan="2" style="text-align: center"> </td> <td> </td> <td> </td> <td colspan="2" style="text-align: center"> </td> <td> </td></tr> <tr style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="text-align: justify">Total reserved for stock options and restricted stock </td> <td> </td> <td> </td> <td style="text-align: right">160,000</td> <td> </td> <td> </td> <td> </td> <td style="text-align: right">10,000,000</td> <td> </td> <td> </td> <td colspan="2" style="text-align: center"> </td> <td> </td></tr> <tr style="vertical-align: bottom; background-color: White"> <td>Net restricted stock issued net of cancellations </td> <td> </td> <td> </td> <td style="text-align: right">(5,000</td> <td>)</td> <td> </td> <td> </td> <td style="text-align: right">(288,866</td> <td>)</td> <td> </td> <td colspan="2" style="text-align: center"> </td> <td> </td></tr> <tr style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td>Stock options granted </td> <td> </td> <td> </td> <td style="text-align: right">(154,449</td> <td>)</td> <td> </td> <td> </td> <td style="text-align: right">(4,293,693</td> <td>)</td> <td> </td> <td colspan="2" style="text-align: center"> </td> <td> </td></tr> <tr style="vertical-align: bottom; background-color: White"> <td>Add back options cancelled before exercise </td> <td> </td> <td> </td> <td style="text-align: right">92,349</td> <td> </td> <td> </td> <td> </td> <td style="text-align: right">1,866,628</td> <td> </td> <td> </td> <td colspan="2" style="text-align: center"> </td> <td> </td></tr> <tr style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td>Less shares no longer available due to Plan expiration </td> <td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: black 1pt solid"> </td> <td style="border-bottom: black 1pt solid; text-align: right">(92,900</td> <td style="padding-bottom: 1.5pt">)</td> <td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: black 1pt solid"> </td> <td style="border-bottom: black 1pt solid; text-align: right">—</td> <td style="padding-bottom: 1.5pt"> </td> <td> </td> <td colspan="2" style="text-align: center"> </td> <td> </td></tr> <tr style="vertical-align: bottom; background-color: White"> <td style="text-align: justify">Remaining shares available for future grants at September 30, 2016</td> <td style="padding-bottom: 3pt"> </td> <td style="border-bottom: black 1.5pt double"> </td> <td style="border-bottom: black 1.5pt double; text-align: right">—</td> <td style="padding-bottom: 3pt"> </td> <td style="padding-bottom: 3pt"> </td> <td style="border-bottom: black 1.5pt double"> </td> <td style="border-bottom: black 1.5pt double; text-align: right">7,284,069</td> <td style="padding-bottom: 3pt"> </td> <td> </td> <td colspan="2" style="text-align: center"> </td> <td> </td></tr> <tr style="background-color: rgb(204,238,255)"> <td colspan="4" style="vertical-align: bottom"> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td></tr> <tr style="vertical-align: bottom; background-color: White"> <td style="width: 64%; text-align: justify">Stock options granted </td> <td style="width: 1%"> </td> <td style="width: 0%"> </td> <td style="width: 9%; text-align: right">154,449</td> <td style="width: 1%"> </td> <td style="width: 1%"> </td> <td style="width: 0%"> </td> <td style="width: 9%; text-align: right">4,293,693</td> <td> </td> <td style="width: 1%"> </td> <td style="width: 0%"> </td> <td style="width: 9%; text-align: right">310,000</td> <td style="width: 1%"> </td></tr> <tr style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td>Less:    Stock options cancelled</td> <td> </td> <td> </td> <td style="text-align: right">(92,349</td> <td>)</td> <td> </td> <td> </td> <td style="text-align: right">(1,866,628</td> <td>)</td> <td> </td> <td> </td> <td style="text-align: right">(243,333</td> <td>)</td></tr> <tr style="vertical-align: bottom; background-color: White"> <td>            Stock options exercised </td> <td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: black 1pt solid"> </td> <td style="border-bottom: black 1pt solid; text-align: right">(35,600</td> <td style="padding-bottom: 1.5pt">)</td> <td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: black 1pt solid"> </td> <td style="border-bottom: black 1pt solid; text-align: right">(23,500</td> <td style="padding-bottom: 1.5pt">)</td> <td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: black 1pt solid"> </td> <td style="border-bottom: black 1pt solid; text-align: right">(66,667</td> <td style="padding-bottom: 1.5pt">)</td></tr> <tr style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="text-align: justify">Net shares outstanding before restricted stock </td> <td> </td> <td> </td> <td style="text-align: right">26,500</td> <td> </td> <td> </td> <td> </td> <td style="text-align: right">2,403,565</td> <td> </td> <td> </td> <td> </td> <td style="text-align: right">—</td> <td> </td></tr> <tr style="vertical-align: bottom; background-color: White"> <td style="text-align: justify">Net restricted stock issued net of cancellations </td> <td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: black 1pt solid"> </td> <td style="border-bottom: black 1pt solid; text-align: right">5,000</td> <td style="padding-bottom: 1.5pt"> </td> <td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: black 1pt solid"> </td> <td style="border-bottom: black 1pt solid; text-align: right">288,866</td> <td style="padding-bottom: 1.5pt"> </td> <td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: black 1pt solid"> </td> <td style="border-bottom: black 1pt solid; text-align: right">6,485</td> <td style="padding-bottom: 1.5pt"> </td></tr> <tr style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="text-align: justify">Outstanding shares at September 30, 2016 </td> <td style="padding-bottom: 3pt"> </td> <td style="border-bottom: black 1.5pt double"> </td> <td style="border-bottom: black 1.5pt double; text-align: right">31,500</td> <td style="padding-bottom: 3pt"> </td> <td style="padding-bottom: 3pt"> </td> <td style="border-bottom: black 1.5pt double"> </td> <td style="border-bottom: black 1.5pt double; text-align: right">2,692,431</td> <td style="padding-bottom: 3pt"> </td> <td style="padding-bottom: 3pt"> </td> <td style="border-bottom: black 1.5pt double"> </td> <td style="border-bottom: black 1.5pt double; text-align: right">6,485</td> <td style="padding-bottom: 3pt"> </td></tr> </table>

<table cellspacing="0" cellpadding="0" style="font: 12pt Times New Roman, Times, Serif; width: 100%"> <tr style="vertical-align: bottom"> <td>         Stock Options</td> <td style="padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: black 1pt solid">         Shares</td> <td style="padding-bottom: 1.5pt"> </td> <td style="padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: black 1pt solid">   Weighted- Average Exercise Price</td> <td style="padding-bottom: 1.5pt"> </td> <td style="padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: black 1pt solid"> Weighted- Average Remaining Contractual Term (years)</td> <td style="padding-bottom: 1.5pt"> </td> <td style="padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: black 1pt solid">     Aggregate Intrinsic Value</td> <td style="padding-bottom: 1.5pt"> </td></tr> <tr style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td>Outstanding options at January 1, 2016 </td> <td> </td> <td> </td> <td style="text-align: right">1,667,233</td> <td> </td> <td> </td> <td>$</td> <td style="text-align: right">2.01</td> <td> </td> <td> </td> <td colspan="2" style="text-align: center"> </td> <td> </td> <td> </td> <td colspan="2" style="text-align: center"> </td> <td> </td></tr> <tr style="vertical-align: bottom; background-color: White"> <td>Granted </td> <td> </td> <td> </td> <td style="text-align: right">1,222,810</td> <td> </td> <td> </td> <td>$</td> <td style="text-align: right">1.28</td> <td> </td> <td> </td> <td colspan="2" style="text-align: center"> </td> <td> </td> <td> </td> <td colspan="2" style="text-align: center"> </td> <td> </td></tr> <tr style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td>Exercised </td> <td> </td> <td> </td> <td style="text-align: right">(10,500</td> <td>)</td> <td> </td> <td>$</td> <td style="text-align: right">1.19</td> <td> </td> <td> </td> <td colspan="2" style="text-align: center"> </td> <td> </td> <td> </td> <td colspan="2" style="text-align: center"> </td> <td> </td></tr> <tr style="vertical-align: bottom; background-color: White"> <td>Forfeited or expired </td> <td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: black 1pt solid"> </td> <td style="border-bottom: black 1pt solid; text-align: right">(449,478</td> <td style="padding-bottom: 1.5pt">)</td> <td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: black 1pt solid">$</td> <td style="border-bottom: black 1pt solid; text-align: right">2.47</td> <td style="padding-bottom: 1.5pt"> </td> <td style="padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: black 1pt solid; text-align: center"> </td> <td style="padding-bottom: 1.5pt"> </td> <td style="padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: black 1pt solid; text-align: center"> </td> <td style="padding-bottom: 1.5pt"> </td></tr> <tr style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="width: 52%">Outstanding options at September 30, 2016 </td> <td style="width: 1%; padding-bottom: 3pt"> </td> <td style="width: 1%; border-bottom: black 1.5pt double"> </td> <td style="width: 9%; border-bottom: black 1.5pt double; text-align: right">2,430,065</td> <td style="width: 1%; padding-bottom: 3pt"> </td> <td style="width: 1%; padding-bottom: 3pt"> </td> <td style="width: 1%; border-bottom: black 1.5pt double">$</td> <td style="width: 9%; border-bottom: black 1.5pt double; text-align: right">1.56</td> <td style="width: 1%; padding-bottom: 3pt"> </td> <td style="width: 1%; padding-bottom: 3pt"> </td> <td style="width: 1%; border-bottom: black 1.5pt double"> </td> <td style="width: 9%; border-bottom: black 1.5pt double; text-align: right">8.63</td> <td style="width: 1%; padding-bottom: 3pt"> </td> <td style="width: 1%; padding-bottom: 3pt"> </td> <td style="width: 1%; border-bottom: black 1.5pt double">$</td> <td style="width: 9%; border-bottom: black 1.5pt double; text-align: right">—</td> <td style="width: 1%; padding-bottom: 3pt"> </td></tr> <tr style="vertical-align: bottom; background-color: White"> <td>Exercisable options at September 30, 2016 </td> <td style="padding-bottom: 3pt"> </td> <td style="border-bottom: black 1.5pt double"> </td> <td style="border-bottom: black 1.5pt double; text-align: right">1,622,072</td> <td style="padding-bottom: 3pt"> </td> <td style="padding-bottom: 3pt"> </td> <td style="border-bottom: black 1.5pt double">$</td> <td style="border-bottom: black 1.5pt double; text-align: right">1.59</td> <td style="padding-bottom: 3pt"> </td> <td style="padding-bottom: 3pt"> </td> <td style="border-bottom: black 1.5pt double"> </td> <td style="border-bottom: black 1.5pt double; text-align: right">8.48</td> <td style="padding-bottom: 3pt"> </td> <td style="padding-bottom: 3pt"> </td> <td style="border-bottom: black 1.5pt double">$</td> <td style="border-bottom: black 1.5pt double; text-align: right">—</td> <td style="padding-bottom: 3pt"> </td></tr> </table>

<table cellspacing="0" cellpadding="0" style="font: 12pt Times New Roman, Times, Serif; width: 100%"> <tr style="vertical-align: bottom"> <td>Restricted Stock</td> <td style="padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: black 1pt solid">       Shares</td> <td style="padding-bottom: 1.5pt"> </td> <td style="padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: black 1pt solid"> Weighted- Average Grant-Date Fair Value</td> <td style="padding-bottom: 1.5pt"> </td></tr> <tr style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="width: 76%">Non-vested shares at January 1, 2016 </td> <td style="width: 1%"> </td> <td style="width: 1%"> </td> <td style="width: 9%; text-align: right">27,842</td> <td style="width: 1%"> </td> <td style="width: 1%"> </td> <td style="width: 1%">$</td> <td style="width: 9%; text-align: right">13.06</td> <td style="width: 1%"> </td></tr> <tr style="vertical-align: bottom; background-color: White"> <td>Granted </td> <td> </td> <td> </td> <td style="text-align: right">280,000</td> <td> </td> <td> </td> <td>$</td> <td style="text-align: right">1.13</td> <td> </td></tr> <tr style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td>Vested </td> <td> </td> <td> </td> <td style="text-align: right">(2,020</td> <td>)</td> <td> </td> <td>$</td> <td style="text-align: right">8.68</td> <td> </td></tr> <tr style="vertical-align: bottom; background-color: White"> <td>Forfeited </td> <td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: black 1pt solid"> </td> <td style="border-bottom: black 1pt solid; text-align: right">(5,471</td> <td style="padding-bottom: 1.5pt">)</td> <td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: black 1pt solid">$</td> <td style="border-bottom: black 1pt solid; text-align: right">7.67</td> <td style="padding-bottom: 1.5pt"> </td></tr> <tr style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td>Non-vested shares at September 30, 2016 </td> <td style="padding-bottom: 3pt"> </td> <td style="border-bottom: black 1.5pt double"> </td> <td style="border-bottom: black 1.5pt double; text-align: right">300,351</td> <td style="padding-bottom: 3pt"> </td> <td style="padding-bottom: 3pt"> </td> <td style="border-bottom: black 1.5pt double">$</td> <td style="border-bottom: black 1.5pt double; text-align: right">2.07</td> <td style="padding-bottom: 3pt"> </td></tr> </table>

<table cellpadding="0" cellspacing="0" style="border-collapse: collapse; width: 100%; font: 12pt Times New Roman, Times, Serif"> <tr style="vertical-align: bottom"> <td>Type of Warrant/Range of Exercise Prices</td><td> </td> <td colspan="3"> </td><td> </td> <td colspan="3"> </td><td> </td> <td colspan="3" style="text-align: center">Expirations</td><td> </td> <td colspan="3" style="text-align: center">Number Outstanding</td><td> </td> <td colspan="3" style="text-align: center">Weighted-Average RemainingContractual Life (years)</td><td> </td> <td colspan="3" style="text-align: center">Weighted- Average Exercise Price</td><td> </td> <td>Number Exercisable</td></tr> <tr style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="font-size: 8pt"> Derivative:</td><td> </td> <td style="text-align: left"> </td><td style="text-align: right"> </td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td style="text-align: right"> </td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td style="text-align: right"> </td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td style="text-align: right"> </td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td style="text-align: right"> </td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td style="text-align: right"> </td><td style="text-align: left"> </td></tr> <tr style="vertical-align: bottom; background-color: White"> <td style="width: 22%"> </td><td style="width: 1%; font-size: 8pt"> </td> <td style="width: 1%; font-size: 8pt; text-align: left"> </td><td style="width: 10%; font-size: 8pt; text-align: right"> </td><td style="width: 1%; font-size: 8pt; text-align: left"> </td><td style="width: 1%; font-size: 8pt"> </td> <td style="width: 1%; font-size: 8pt; text-align: left">$</td><td style="width: 10%; font-size: 8pt; text-align: right">1.50</td><td style="width: 1%; font-size: 8pt; text-align: left"> </td><td style="width: 1%; font-size: 8pt"> </td> <td style="width: 1%; font-size: 8pt; text-align: left"> </td><td style="width: 10%; font-size: 8pt; text-align: right">7/29/21</td><td style="width: 1%; font-size: 8pt; text-align: left"> </td><td style="width: 1%; font-size: 8pt"> </td> <td style="width: 1%; font-size: 8pt; text-align: left"> </td><td style="width: 10%; font-size: 8pt; text-align: right">1,274,280</td><td style="width: 1%; font-size: 8pt; text-align: left"> </td><td style="width: 1%; font-size: 8pt"> </td> <td style="width: 1%; font-size: 8pt; text-align: left"> </td><td style="width: 10%; font-size: 8pt; text-align: right">4.83</td><td style="width: 1%; font-size: 8pt; text-align: left"> </td><td style="width: 1%; font-size: 8pt"> </td> <td style="width: 1%; font-size: 8pt; text-align: left">$</td><td style="width: 10%; font-size: 8pt; text-align: right">1.50</td><td style="width: 1%; font-size: 8pt; text-align: left"> </td><td style="width: 1%; font-size: 8pt"> </td> <td style="font-size: 8pt; text-align: right">1,274,280</td></tr> <tr style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td> </td><td style="font-size: 8pt"> </td> <td style="font-size: 8pt; text-align: left"> </td><td style="font-size: 8pt; text-align: right"> </td><td style="font-size: 8pt; text-align: left"> </td><td style="font-size: 8pt"> </td> <td style="font-size: 8pt; text-align: left">$</td><td style="font-size: 8pt; text-align: right">1.50</td><td style="font-size: 8pt; text-align: left"> </td><td style="font-size: 8pt"> </td> <td style="font-size: 8pt; text-align: left"> </td><td style="font-size: 8pt; text-align: right">5/3/18</td><td style="font-size: 8pt; text-align: left"> </td><td style="font-size: 8pt"> </td> <td style="font-size: 8pt; text-align: left"> </td><td style="font-size: 8pt; text-align: right">2,278,595</td><td style="font-size: 8pt; text-align: left"> </td><td style="font-size: 8pt"> </td> <td style="font-size: 8pt; text-align: left"> </td><td style="font-size: 8pt; text-align: right">1.59</td><td style="font-size: 8pt; text-align: left"> </td><td style="font-size: 8pt"> </td> <td style="font-size: 8pt; text-align: left">$</td><td style="font-size: 8pt; text-align: right">1.50</td><td style="font-size: 8pt; text-align: left"> </td><td style="font-size: 8pt"> </td> <td style="font-size: 8pt; text-align: right">2,278,595</td></tr> <tr style="vertical-align: bottom; background-color: White"> <td> </td><td style="font-size: 8pt"> </td> <td style="font-size: 8pt; text-align: left"> </td><td style="font-size: 8pt; text-align: right"> </td><td style="font-size: 8pt; text-align: left"> </td><td style="font-size: 8pt"> </td> <td style="font-size: 8pt; text-align: left">$</td><td style="font-size: 8pt; text-align: right">7.50</td><td style="font-size: 8pt; text-align: left"> </td><td style="font-size: 8pt"> </td> <td style="font-size: 8pt; text-align: left"> </td><td style="font-size: 8pt; text-align: right">8/31/17 to 11/6/17</td><td style="font-size: 8pt; text-align: left"> </td><td style="font-size: 8pt"> </td> <td style="font-size: 8pt; text-align: left"> </td><td style="font-size: 8pt; text-align: right">700,000</td><td style="font-size: 8pt; text-align: left"> </td><td style="font-size: 8pt"> </td> <td style="font-size: 8pt; text-align: left"> </td><td style="font-size: 8pt; text-align: right">0.97</td><td style="font-size: 8pt; text-align: left"> </td><td style="font-size: 8pt"> </td> <td style="font-size: 8pt; text-align: left">$</td><td style="font-size: 8pt; text-align: right">7.50</td><td style="font-size: 8pt; text-align: left"> </td><td style="font-size: 8pt"> </td> <td style="font-size: 8pt; text-align: right">700,000</td></tr> <tr style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="font-size: 8pt">Equity:</td><td> </td> <td style="text-align: left"> </td><td style="text-align: right"> </td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td style="text-align: right"> </td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td style="text-align: right"> </td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td style="text-align: right"> </td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td style="text-align: right"> </td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td style="text-align: right"> </td><td style="text-align: left"> </td></tr> <tr style="vertical-align: bottom; background-color: White"> <td style="padding-bottom: 1pt"> </td><td style="font-size: 8pt; padding-bottom: 1pt"> </td> <td style="border-bottom: Black 1pt solid; font-size: 8pt; text-align: left"> </td><td style="border-bottom: Black 1pt solid; font-size: 8pt; text-align: right">$</td><td style="padding-bottom: 1pt; font-size: 8pt; text-align: left"> </td><td style="font-size: 8pt; padding-bottom: 1pt"> </td> <td style="border-bottom: Black 1pt solid; font-size: 8pt; text-align: left"> </td><td style="border-bottom: Black 1pt solid; font-size: 8pt; text-align: right">2.75 - $3.00</td><td style="padding-bottom: 1pt; font-size: 8pt; text-align: left"> </td><td style="font-size: 8pt; padding-bottom: 1pt"> </td> <td style="border-bottom: Black 1pt solid; font-size: 8pt; text-align: left"> </td><td style="border-bottom: Black 1pt solid; font-size: 8pt; text-align: right">12/10/18 to 10//30/20</td><td style="padding-bottom: 1pt; font-size: 8pt; text-align: left"> </td><td style="font-size: 8pt; padding-bottom: 1pt"> </td> <td style="border-bottom: Black 1pt solid; font-size: 8pt; text-align: left"> </td><td style="border-bottom: Black 1pt solid; font-size: 8pt; text-align: right">3,830,428</td><td style="padding-bottom: 1pt; font-size: 8pt; text-align: left"> </td><td style="font-size: 8pt; padding-bottom: 1pt"> </td> <td style="border-bottom: Black 1pt solid; font-size: 8pt; text-align: left"> </td><td style="border-bottom: Black 1pt solid; font-size: 8pt; text-align: right">3.44</td><td style="padding-bottom: 1pt; font-size: 8pt; text-align: left"> </td><td style="font-size: 8pt; padding-bottom: 1pt"> </td> <td style="border-bottom: Black 1pt solid; font-size: 8pt; text-align: left">$</td><td style="border-bottom: Black 1pt solid; font-size: 8pt; text-align: right">2.98</td><td style="padding-bottom: 1pt; font-size: 8pt; text-align: left"> </td><td style="font-size: 8pt; padding-bottom: 1pt"> </td> <td style="border-bottom: Black 1pt solid; font-size: 8pt; text-align: right">3,830,428</td></tr> <tr style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="font-size: 8pt; text-align: left; padding-bottom: 2.5pt">Total outstanding</td><td style="padding-bottom: 2.5pt"> </td> <td style="border-bottom: Black 2.5pt double; text-align: left"> </td><td style="border-bottom: Black 2.5pt double; text-align: right"> </td><td style="padding-bottom: 2.5pt; text-align: left"> </td><td style="padding-bottom: 2.5pt"> </td> <td style="border-bottom: Black 2.5pt double; text-align: left"> </td><td style="border-bottom: Black 2.5pt double; text-align: right"> </td><td style="padding-bottom: 2.5pt; text-align: left"> </td><td style="font-size: 8pt; padding-bottom: 2.5pt"> </td> <td style="border-bottom: Black 2.5pt double; font-size: 8pt; text-align: left"> </td><td style="border-bottom: Black 2.5pt double; font-size: 8pt; text-align: right">8,083,303</td><td style="padding-bottom: 2.5pt; font-size: 8pt; text-align: left"> </td><td style="padding-bottom: 2.5pt"> </td> <td style="border-bottom: Black 2.5pt double; text-align: left"> </td><td style="border-bottom: Black 2.5pt double; text-align: right"> </td><td style="padding-bottom: 2.5pt; text-align: left"> </td><td style="padding-bottom: 2.5pt"> </td> <td style="border-bottom: Black 2.5pt double; text-align: left"> </td><td style="border-bottom: Black 2.5pt double; text-align: right"> </td><td style="padding-bottom: 2.5pt; text-align: left"> </td><td style="padding-bottom: 2.5pt"> </td> <td style="border-bottom: Black 2.5pt double; text-align: left"> </td><td style="border-bottom: Black 2.5pt double; text-align: right"> </td><td style="padding-bottom: 2.5pt; text-align: left"> </td><td style="font-size: 8pt; padding-bottom: 2.5pt"> </td> <td style="border-bottom: Black 2.5pt double; font-size: 8pt; text-align: right">8,083,303</td></tr> </table>

172725

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P7Y

P5Y

P3Y

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P3Y

P7Y

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0.0190

P3M

P5Y

P5Y6M

P4Y

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October 2016 August 2016 August 2016 N/A -92900 0

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10000000

0 7284069

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5000

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27842

5000

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26500

2403565

7284069

2430065

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1222810

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1.56

2.01

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Among the 300,351 shares of non-vested restricted stock, the various vesting criteria include the following:   <table cellpadding="0" style="width: 100%"> <tr> <td style="vertical-align: top; font: 12pt Times New Roman, Times, Serif; padding: 0.75pt">●</td> <td colspan="2" style="padding: 0.75pt; font: 12pt Times New Roman, Times, Serif; text-align: justify">14,185 shares of restricted stock vest upon the FDA approval of the Company’s CGM system or the sale of the Company; and</td></tr> <tr> <td style="vertical-align: top; font: 12pt Times New Roman, Times, Serif; padding: 0.75pt">●</td> <td style="padding: 0.75pt; font: 12pt Times New Roman, Times, Serif; text-align: justify">6,166 shares of restricted stock vest over 4 years, at each of the anniversary dates of the grants, and</td></tr> </table>   <table cellpadding="0" style="width: 100%; font: 12pt Times New Roman, Times, Serif"> <tr> <td style="vertical-align: top; padding: 0.75pt">●</td> <td style="padding: 0.75pt; text-align: justify">130,000 shares of restricted stock vest 18 months from the date of issuance, and</td></tr> <tr> <td style="vertical-align: top; padding: 0.75pt">●</td> <td colspan="2" style="padding: 0.75pt; text-align: justify">150,000 shares of restricted stock vest quarterly after the company receives debt/equity financing of at least $1 million</td></tr> </table>

8083303

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3.68 1.50 0 2.72

7.50

1.50

8-31-17 to 11-6-17 7-29-2021 5-30-2018

8083303

700000

1274280

2278595

P7Y6M

P4Y9M29D

P1Y7M2D

8083303

700000

1274280

2278595

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For the three months ended September 30, 2016 dilutive EPS includes 5,657,824 incremental shares attributable to the assumed conversion of the January 29, 2016 and May 3, 2016 secured convertible notes and an adjustment of $2,720,727 in net loss for the change in fair value of the related conversion option for such period. No such incremental shares were noted for the nine month period as the calculation is anti-dilutive.

As a result of having warrants which are outstanding, issued in connection with a 2012 Credit Facility (which was terminated in October 2014), the Company is required to record the changes in the value of these derivative warrants through their expirations in November 2017. Additionally as indicated in Note 5 above, Notes and Warrants issued in connection with the Company’s January and May 2016 secured convertible note financing, included certain price/conversion features, which require them to be accounted for as derivatives.   The table below presents the changes in the derivative liability, which is measured at fair value on a recurring basis and classified as Level 3 in fair value hierarchy:   <table cellspacing="0" cellpadding="0" style="font: 12pt Times New Roman, Times, Serif; width: 100%"> <tr style="vertical-align: bottom"> <td> </td> <td style="padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: black 1pt solid; text-align: center">09/30/16</td> <td style="padding-bottom: 1.5pt"> </td> <td style="padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: black 1pt solid; text-align: center">12/31/15</td> <td style="padding-bottom: 1.5pt"> </td></tr> <tr style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="width: 76%">Derivative liabilities as of January 1 </td> <td style="width: 1%"> </td> <td style="width: 1%">$</td> <td style="width: 9%; text-align: right">127,000</td> <td style="width: 1%"> </td> <td style="width: 1%"> </td> <td style="width: 1%">$</td> <td style="width: 9%; text-align: right">208,155</td> <td style="width: 1%"> </td></tr> <tr style="vertical-align: bottom; background-color: White"> <td>Secured convertible note derivatives:</td> <td> </td> <td> </td> <td style="text-align: right"> </td> <td> </td> <td> </td> <td> </td> <td style="text-align: right"> </td> <td> </td></tr> <tr style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td>   Warrants </td> <td> </td> <td> </td> <td style="text-align: right">2,147,574</td> <td> </td> <td> </td> <td> </td> <td style="text-align: right">—</td> <td> </td></tr> <tr style="vertical-align: bottom; background-color: White"> <td>   Embedded conversion feature in Notes </td> <td> </td> <td> </td> <td style="text-align: right">3,173,896</td> <td> </td> <td> </td> <td> </td> <td style="text-align: right">—</td> <td> </td></tr> <tr style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td>Loss (gain) on revaluation </td> <td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: black 1pt solid"> </td> <td style="border-bottom: black 1pt solid; text-align: right">(4,437,776</td> <td style="padding-bottom: 1.5pt">)</td> <td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: black 1pt solid"> </td> <td style="border-bottom: black 1pt solid; text-align: right">(81,155</td> <td style="padding-bottom: 1.5pt">)</td></tr> <tr style="vertical-align: bottom; background-color: White"> <td>Derivative liabilities as of end of period </td> <td style="padding-bottom: 3pt"> </td> <td style="border-bottom: black 1.5pt double">$</td> <td style="border-bottom: black 1.5pt double; text-align: right">1,010,694</td> <td style="padding-bottom: 3pt"> </td> <td style="padding-bottom: 3pt"> </td> <td style="border-bottom: black 1.5pt double">$</td> <td style="border-bottom: black 1.5pt double; text-align: right">127,000</td> <td style="padding-bottom: 3pt"> </td></tr> </table>   None of the derivative warrants were exercised in 2016 or 2015 pursuant to cashless exercise provisions.

Software development costs associated with the planning and designing phase of software development, including coding and testing activities necessary to establish technological feasibility, are expensed as incurred. Once technological feasibility has been determined, a portion of the costs incurred in development, including coding, testing, and quality assurance, are capitalized. $25,170 and $267,811 of costs associated with the application programming of the Company’s smartphone application for its CGM were capitalized in the quarter and nine months ended September 30, 2016, respectively.

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Document and Entity Information - shares	9 Months Ended
Document and Entity Information - shares	Sep. 30, 2016	Oct. 30, 2016
Document And Entity Information
Entity Registrant Name	Echo Therapeutics, Inc.
Entity Central Index Key	0001031927
Document Type	10-Q
Document Period End Date	Sep. 30, 2016
Amendment Flag	false
Current Fiscal Year End Date	--12-31
Is Entity a Well-known Seasoned Issuer?	No
Is Entity a Voluntary Filer?	No
Is Entity's Reporting Status Current?	Yes
Trading Symbol	ECTE
Entity Filer Category	Smaller Reporting Company
Entity Common Stock, Shares Outstanding		12,004,308
Document Fiscal Period Focus	Q3
Document Fiscal Year Focus	2016

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CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited) - USD ($)	Sep. 30, 2016	Dec. 31, 2015
Current Assets:
Cash and cash equivalents	$ 172,725	$ 56,210
Prepaid and other	229,229	244,534
Total current assets	401,954	300,744
Property and equipment, net	188,936	267,671
Other Assets:
Cash restricted pursuant to letters of credit	217,556	236,425
Capitalized software development costs	267,811	0
Other	250	250
Total other assets	485,617	236,675
Total assets	1,076,507	805,090
Current Liabilities:
Accounts payable	1,851,043	2,176,083
Accrued and other	884,253	602,345
Secured convertible notes, net	3,248,731	0
Bridge loans	250,000	330,000
Premium financing	22,638	0
Derivative liabilities	1,010,694	127,000
Total current liabilities	7,267,359	3,235,428
Deferred revenue, net	95,535	95,535
Total liabilities	7,362,894	3,330,963
Commitments and contingencies
Stockholders' deficit:
Common stock, $0.01 par value; 150,000,000 shares authorized; issued and outstanding 11,512,586 and 11,124,496 shares, respectively	116,358	111,243
Additional paid-in capital	148,414,835	147,412,559
Accumulated deficit	(154,897,838)	(150,129,933)
Total stockholders' deficit	(6,286,387)	(2,525,873)
Total liabilities and stockholders' deficit	1,076,507	805,090
Series C Preferred Stock [Member]
Stockholders' deficit:
Preferred Stock, $0.01 par value; 40,000,000 shares authorized: Convertible Series C, D, E, F	10	10
Series D Preferred Stock [Member]
Stockholders' deficit:
Preferred Stock, $0.01 par value; 40,000,000 shares authorized: Convertible Series C, D, E, F	10,000	10,000
Series E Preferred Stock [Member]
Stockholders' deficit:
Preferred Stock, $0.01 par value; 40,000,000 shares authorized: Convertible Series C, D, E, F	17,486	17,486
Series F Preferred Stock [Member]
Stockholders' deficit:
Preferred Stock, $0.01 par value; 40,000,000 shares authorized: Convertible Series C, D, E, F	$ 52,762	$ 52,762

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CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited) (Parenthetical) - $ / shares	Sep. 30, 2016	Dec. 31, 2015
Stockholders' Equity:
Convertible Preferred Stock, par value	$ 0.01	$ 0.01
Convertible Preferred Stock, authorized	40,000,000	40,000,000
Common stock, par value	$ 0.01	$ 0.01
Common stock, authorized	150,000,000	150,000,000
Common stock, outstanding	11,635,915	11,124,496
Common stock, Share Issued	11,635,915	11,124,496
Series C Preferred Stock [Member]
Stockholders' Equity:
Convertible Preferred Stock, par value	$ 0.01	$ 0.01
Convertible Preferred Stock, authorized	10,000	10,000
Convertible Preferred Stock, outstanding	1,000	1,000
Convertible Preferred Stock, Share Issued	1,000	1,000
Series D Preferred Stock [Member]
Stockholders' Equity:
Convertible Preferred Stock, par value	$ 0.01	$ 0.01
Convertible Preferred Stock, authorized	3,600,000	3,600,000
Convertible Preferred Stock, outstanding	1,000,000	1,000,000
Convertible Preferred Stock, Share Issued	1,000,000	1,000,000
Series E Preferred Stock [Member]
Stockholders' Equity:
Convertible Preferred Stock, par value	$ 0.01	$ 0.01
Convertible Preferred Stock, authorized	1,748,613	1,748,613
Convertible Preferred Stock, outstanding	1,748,613	1,748,613
Convertible Preferred Stock, Share Issued	1,748,613	1,748,613
Series F Preferred Stock [Member]
Stockholders' Equity:
Convertible Preferred Stock, par value	$ 0.01	$ 0.01
Convertible Preferred Stock, authorized	6,000,000	6,000,000
Convertible Preferred Stock, outstanding	5,276,180	5,276,180
Convertible Preferred Stock, Share Issued	5,276,180	5,276,180

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CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited) - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2016	Sep. 30, 2015	Sep. 30, 2016	Sep. 30, 2015
Income Statement [Abstract]
Licensing revenue	$ 0	$ 0	$ 0	$ 0
Total revenues	0	0	0	0
Operating Expenses:
Research and development	588,551	558,995	1,943,287	2,027,896
Selling, general and administrative	1,198,328	820,662	2,927,716	3,815,746
Impairment charge	0	0	0	9,625,000
Loss (gain) on disposal of property and equipment	0	39,382	(4,000)	278,816
Depreciation and amortization	26,925	39,171	85,090	487,491
Total operating expenses	1,813,804	1,458,210	4,952,093	16,234,949
Loss from operations	(1,813,804)	(1,458,210)	(4,952,093)	(16,234,949)
Other Income (Expense):
Gain (loss) on revaluation of derivative liabilities	3,675,826	(54,000)	4,437,776	(61,845)
Financing loss	0	(263,000)	0	(4,620,000)
Loss on early extinguishment of bridge loans	0	0	(2,143,960)	0
Amortization of debt discount	(934,794)	0	(1,830,012)	0
Interest expense	(133,057)	(212)	(279,616)	(4,938)
Other income (expense), net	2,607,975	(317,212)	184,188	(4,686,783)
Net income (loss)	794,171	(1,775,422)	(4,767,905)	(20,921,732)
Deemed dividend on beneficial conversion feature of preferred stock	0	0	(6,460,818)	0
Net income (loss) applicable to common shareholders	$ 794,171	$ (1,775,422)	$ (11,228,773)	$ (20,921,732)
Net loss per common share, basic	$ 0.07	$ (0.16)	$ (0.98)	$ (1.86)
Net loss per common share, diluted	$ (.11)	$ (0.16)	$ (.98)	$ (1.86)
Basic weighted average common shares outstanding	11,603,868	11,127,475	11,418,653	11,266,571
Diluted weighted average common shares outstanding	17,261,692	11,127,475	11,418,653	11,266,571

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CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS' DEFICIT (Unaudited) - 9 months ended Sep. 30, 2016 - USD ($)	Preferred Stock	Common Stock	Additional Paid-In Capital	Accumulated Deficit	Total
Beginning Balance, Shares at Dec. 31, 2015	8,025,793	11,124,496
Beginning Balance, Amount at Dec. 31, 2015	$ 80,258	$ 111,243	$ 147,412,559	$ 150,129,933	$ (2,525,873)
Share-based compensation, net of restricted stock cancellations, Shares		275,695
Share-based compensation, net of restricted stock cancellations, Amount		$ 2,757	700,106		702,863
Exercise of stock options, Shares		2,246
Exercise of stock options, Amount		$ 23	(23)		0
Settlement of account payable, Shares		57,121
Settlement of account payable, Amount		$ 571	93,079	0	93,650
Payment of interest, Shares		101,357
Payment of interest, Amount		$ 1,014	130,614	0	131,628
Payment of investor relations, Shares		75,000
Payment of investor relations, Amount		$ 750	78,500		79,250
Net loss				(4,767,905)	(4,767,905)
Ending Balance, Shares at Sep. 30, 2016	8,025,793	11,635,915
Ending balance, Amount at Sep. 30, 2016	$ 80,258	$ 116,358	$ 148,414,835	$ 154,897,838	$ (6,286,387)

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CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited) - USD ($)	9 Months Ended
	Sep. 30, 2016	Sep. 30, 2015
Cash Flows From Operating Activities:
Net loss	$ (4,767,905)	$ (20,921,732)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization	85,090	487,491
Amortization of debt discount	1,830,012	0
Share-based compensation, net	702,863	798,250
Loss on early extinguishment of bridge loans	2,143,960	0
(Gain) loss on revaluation of derivative liabilities	(4,437,776)	61,845
Warrant repricing charged to legal expense	0	328,000
(Gain) Loss on disposal of assets	(4,000)	278,816
Impairment charge	0	9,625,000
Financing loss	0	4,620,000
Changes in assets and liabilities:
Prepaid and other	15,318	(4,853)
Accounts payable	(152,154)	395,973
Accrued and other	417,156	(100,836)
Net cash used in operating activities	(4,167,436)	(4,432,046)
Cash Flows from Investing Activities:
Purchase of property and equipment	(6,354)	(55,836)
Decrease in restricted cash	18,869	(183,938)
Capitalization of software development costs	(267,811)	0
Proceeds on disposal of property and equipment	4,000	126,082
Net cash used ininvesting activities	(251,296)	(113,692)
Cash Flows From Financing Activities:
Proceeds from secured convertible notes, net of related costs	2,512,609	0
Proceeds from bridge loans	2,000,000	0
Proceeds from equity financing	0	3,181,500
Proceeds from premium financing	199,671	272,622
Principal payments from premium financing	(177,033)	(243,420)
Capital contribution	0	59,325
Net cash provided by financing activities	4,535,247	3,270,027
Net increase in cash and cash equivalents	116,515	(1,275,711)
Beginning of period	56,210	1,278,941
End of period	172,725	3,230
Supplemental disclosure of cash flow information:
Interest	15,709	5,043
Income taxes	2,761	0
Supplemental disclosure of non-cash financing transactions:
Deemed dividend on beneficial conversion feature of convertible preferred stock	6,460,818	0
Directors fees payable offset against prepaid insurance	0	272,200
Security deposit offset against accounts payable	0	9,740
Accrued legal fees settled with stock	0	550,000
Bridge loans exchanged for secured convertible notes	2,080,000	0
Derivatives offset against secured convertible notes	5,321,470	0
Conversion of convertible preferred stock into Common Stock at par value	0	15,000
Accrued interest settled with stock	131,628	0
Account payable settled with stock	172,900	0
Subscriptions receivable for Series F Preferred Stock	$ 0	$ 300,000

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ORGANIZATION AND BASIS OF PRESENTATION

9 Months Ended

Sep. 30, 2016

Organization, Consolidation and Presentation of Financial Statements [Abstract]

ORGANIZATION AND BASIS OF PRESENTATION

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LIQUIDITY AND MANAGEMENT'S PLANS	9 Months Ended
LIQUIDITY AND MANAGEMENT'S PLANS	Sep. 30, 2016
Liquidity And Managements Plans
LIQUIDITY AND MANAGEMENT'S PLANS	The accompanying financial statements have been prepared on a basis that assumes that the Company will continue as a going concern and that contemplates the continuity of operations, the realization of assets and the satisfaction of liabilities and commitments in the normal course of business. As of September 30, 2016, the Company had cash of $172,725, working capital deficit of ($6,865,405) and an accumulated deficit of ($154,897,838). The Company continues to incur recurring losses from operations. The Company’s losses have resulted principally from costs incurred in connection with its research and development activities and from general and administrative costs associated with its operations. The Company also expects to have negative cash flows for the foreseeable future as it funds its operational losses and capital expenditures. This will result in decreases in the Company’s working capital, total assets and stockholders’ equity, which may not be offset by future funding. The Company will need to secure additional capital to fund its product development, research, manufacturing and clinical programs in accordance with its current planned operations. The Company has funded its operations in the past primarily through debt and equity issuances. Management will continue to pursue financing to fund its operations. No assurances can be given that additional capital will be available on terms acceptable to the Company. The accompanying financial statements do not include any adjustments that might result from the outcome of the uncertainty.

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PROPERTY AND EQUIPMENT

9 Months Ended

Sep. 30, 2016

Property, Plant and Equipment [Abstract]

PROPERTY AND EQUIPMENT

The principal categories and estimated useful lives of property and equipment were:

	09/30/16		12/31/15		Estimated Useful Lives
Computer equipment	$	335,298	$	332,764		3
Office and laboratory equipment		603,226		628,726		3-5
Furniture and fixtures		228,099		228,099		7
Manufacturing equipment		65,819		61,998		5
Leasehold improvements		41,968		41,968		3-7
Total property and equipment		1,274,410		1,293,555
Less accumulated depreciation and amortization		1,085,474		1,025,884
Property and equipment, net	$	188,936	$	267,671

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CAPITALIZED SOFTWARE DEVELOPMENT COSTS	9 Months Ended
CAPITALIZED SOFTWARE DEVELOPMENT COSTS	Sep. 30, 2016
Capitalized Software Development Costs
CAPITALIZED SOFTWARE DEVELOPMENT COSTS	Software development costs associated with the planning and designing phase of software development, including coding and testing activities necessary to establish technological feasibility, are expensed as incurred. Once technological feasibility has been determined, a portion of the costs incurred in development, including coding, testing, and quality assurance, are capitalized. $25,170 and $267,811 of costs associated with the application programming of the Company’s smartphone application for its CGM were capitalized in the quarter and nine months ended September 30, 2016, respectively.

- Definition

The entire disclosure for research, development, and computer software activities, including contracts and arrangements to be performed for others and with federal government. Includes costs incurred (1) in a planned search or critical investigation aimed at discovery of new knowledge with the hope that such knowledge will be useful in developing a new product or service, a new process or technique, or in bringing about a significant improvement to an existing product or process; or (2) to translate research findings or other knowledge into a plan or design for a new product or process or for a significant improvement to an existing product or process whether intended for sale or the entity's use, during the reporting period charged to research and development projects, including the costs of developing computer software up to the point in time of achieving technological feasibility and in-process research and development acquired in a business combination consummated during the period.

+ References + Details

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FINANCING TRANSACTIONS

9 Months Ended

Sep. 30, 2016

Financing Transactions

FINANCING TRANSACTIONS

The assumptions utilized for the embedded conversion feature valuation, which reflect the initial valuation at January 29th, May 3rd and subsequent valuation at September 30, 2016, were as follows:

Risk-free interest rate %	0.34 – 0.48
Expected dividend yield	—
Expected term - years (contractual term)	0.33 – 0.59
Forfeiture rate	—
Expected volatility %	112
Timing of down-round triggering event	October 2016

Follows is a summary of the Notes and related discounts and the Loss on the early extinguishment of bridge loans:

	Original Value		Loss on Early Extinguishment of Bridge Loans			Secured Convertible Notes, net
Cash and other proceeds received from financing		—		—		$	5,148,620
Warrants	$	2,147,574		(831,109	)		(1,316,465	)
Embedded conversion feature in notes	$	3,173,896		(1,312,851	)		(1,861,045	)
Financing costs		—		—			(552,391	)
Amortization of debt discount		—		—			1,830,012
Totals, net	$	5,321,470	$	(2,143,960	)	$	3,248,731

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DERIVATIVE LIABILITIES

9 Months Ended

Sep. 30, 2016

Derivative Instruments and Hedging Activities Disclosure [Abstract]

DERIVATIVE LIABILITY

The table below presents the changes in the derivative liability, which is measured at fair value on a recurring basis and classified as Level 3 in fair value hierarchy:

	09/30/16			12/31/15
Derivative liabilities as of January 1	$	127,000		$	208,155
Secured convertible note derivatives:
Warrants		2,147,574			—
Embedded conversion feature in Notes		3,173,896			—
Loss (gain) on revaluation		(4,437,776	)		(81,155	)
Derivative liabilities as of end of period	$	1,010,694		$	127,000

None of the derivative warrants were exercised in 2016 or 2015 pursuant to cashless exercise provisions.

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NET LOSS PER SHARE	9 Months Ended
NET LOSS PER SHARE	Sep. 30, 2016
Net Loss Per Share
NET LOSS PER SHARE	For the three months ended September 30, 2016 dilutive EPS includes 5,657,824 incremental shares attributable to the assumed conversion of the January 29, 2016 and May 3, 2016 secured convertible notes and an adjustment of $2,720,727 in net loss for the change in fair value of the related conversion option for such period. No such incremental shares were noted for the nine month period as the calculation is anti-dilutive.

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EQUITY COMPENSATION PLANS

9 Months Ended

Sep. 30, 2016

Equity Compensation Plans

EQUITY COMPENSATION PLANS

The following table shows the remaining shares available for future grants for each plan and outstanding shares:

	Equity Compensation Plans						Not Pursuant
	2003 Plan			2008 Plan			to a Plan
Shares Available For Issuance
Total reserved for stock options and restricted stock		160,000			10,000,000
Net restricted stock issued net of cancellations		(5,000	)		(288,866	)
Stock options granted		(154,449	)		(4,293,693	)
Add back options cancelled before exercise		92,349			1,866,628
Less shares no longer available due to Plan expiration		(92,900	)		—
Remaining shares available for future grants at September 30, 2016		—			7,284,069

Stock options granted		154,449			4,293,693			310,000
Less: Stock options cancelled		(92,349	)		(1,866,628	)		(243,333	)
Stock options exercised		(35,600	)		(23,500	)		(66,667	)
Net shares outstanding before restricted stock		26,500			2,403,565			—
Net restricted stock issued net of cancellations		5,000			288,866			6,485
Outstanding shares at September 30, 2016		31,500			2,692,431			6,485

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STOCK OPTIONS

9 Months Ended

Sep. 30, 2016

Stock Options

STOCK OPTIONS

The assumptions used principally for stock options granted to employees and members of the Company’s Board of Directors in the nine months ended September 30, 2016 and 2015 were as follows:

	2016		2015
Risk-free interest rate %		0.18 – 1.07		1.46 – 1.90
Expected dividend yield		—		—
Expected term - years		.25 – 4		5 – 5.5
Forfeiture rate % (excluding fully vested stock options)		2 – 5		7.5 - 15
Expected volatility %		0.94 – 1.28		0.92 – 0.93

A summary of stock option activity for the nine months ended September 30, 2016 is as follows:

Stock Options	Shares			Weighted- Average Exercise Price		Weighted- Average Remaining Contractual Term (years)		Aggregate Intrinsic Value
Outstanding options at January 1, 2016		1,667,233		$	2.01
Granted		1,222,810		$	1.28
Exercised		(10,500	)	$	1.19
Forfeited or expired		(449,478	)	$	2.47
Outstanding options at September 30, 2016		2,430,065		$	1.56		8.63	$	—
Exercisable options at September 30, 2016		1,622,072		$	1.59		8.48	$	—

- Definition

The entire disclosure for compensation-related costs for equity-based compensation, which may include disclosure of policies, compensation plan details, allocation of equity compensation, incentive distributions, equity-based arrangements to obtain goods and services, deferred compensation arrangements, employee stock ownership plan details and employee stock purchase plan details.

+ References + Details

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RESTRICTED STOCK

9 Months Ended

Sep. 30, 2016

Restricted Stock

RESTRICTED STOCK

A summary of non-vested restricted stock activity for the nine months ended September 30, 2016 is as follows:

Restricted Stock	Shares			Weighted- Average Grant-Date Fair Value
Non-vested shares at January 1, 2016		27,842		$	13.06
Granted		280,000		$	1.13
Vested		(2,020	)	$	8.68
Forfeited		(5,471	)	$	7.67
Non-vested shares at September 30, 2016		300,351		$	2.07

Among the 300,351 shares of non-vested restricted stock, the various vesting criteria include the following:

●	14,185 shares of restricted stock vest upon the FDA approval of the Company’s CGM system or the sale of the Company; and
●	6,166 shares of restricted stock vest over 4 years, at each of the anniversary dates of the grants, and

●	130,000 shares of restricted stock vest 18 months from the date of issuance, and
●	150,000 shares of restricted stock vest quarterly after the company receives debt/equity financing of at least $1 million

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WARRANTS

9 Months Ended

Sep. 30, 2016

Warrants

WARRANTS

In the nine months ended September 30, 2016, the Company issued warrants to purchase 3,552,875 shares of the Company’s common stock in connection with its Note financing. See Note 5.

A summary of warrant activity for the nine months ended September 30, 2016 is as follows:

Warrants	Shares		Weighted- Average Exercise Price
Outstanding warrants at January 1, 2016		4,530,428	$	3.68
Granted		3,552,875	$	1.50
Forfeited		—	$	—
Outstanding warrants at September 30, 2016		8,083,303	$	2.72

At September 30, 2016, the Company had the following outstanding warrants:

Type of Warrant/Range of Exercise Prices				Expirations		Number Outstanding		Weighted-Average RemainingContractual Life (years)		Weighted- Average Exercise Price		Number Exercisable
Derivative:
		$	1.50		7/29/21		1,274,280		4.83	$	1.50	1,274,280
		$	1.50		5/3/18		2,278,595		1.59	$	1.50	2,278,595
		$	7.50		8/31/17 to 11/6/17		700,000		0.97	$	7.50	700,000
Equity:
	$		2.75 - $3.00		12/10/18 to 10//30/20		3,830,428		3.44	$	2.98	3,830,428
Total outstanding					8,083,303							8,083,303

The following assumptions were utilized by the Company:

By expiration:	7/29/21		5/3/18			8/31/17 - 11/6/17
Risk-free interest rate %		1.03		0.56			0.73
Expected dividend yield		—		—			—
Expected term - years (contractual term)		5.15		1.87			1.17 - 1.35
Forfeiture rate		—		—			—
Expected volatility %		103		103			84.95
Timing of down-round triggering event		August 2016			N/A

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LITIGATION & OTHER SIGNIFICANT MATTERS

9 Months Ended

Sep. 30, 2016

Litigation Other Significant Matters

LITIGATION & OTHER SIGNIFICANT MATTERS

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SUBSEQUENT EVENTS

9 Months Ended

Sep. 30, 2016

Subsequent Events [Abstract]

SUBSEQUENT EVENTS

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PROPERTY AND EQUIPMENT (Tables)

9 Months Ended

Sep. 30, 2016

Property, Plant and Equipment [Abstract]

PROPERTY AND EQUIPMENT

	09/30/16		12/31/15		Estimated Useful Lives
Computer equipment	$	335,298	$	332,764		3
Office and laboratory equipment		603,226		628,726		3-5
Furniture and fixtures		228,099		228,099		7
Manufacturing equipment		65,819		61,998		5
Leasehold improvements		41,968		41,968		3-7
Total property and equipment		1,274,410		1,293,555
Less accumulated depreciation and amortization		1,085,474		1,025,884
Property and equipment, net	$	188,936	$	267,671

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FINANCING TRANSACTIONS (Tables)

9 Months Ended

Sep. 30, 2016

Debt Disclosure [Abstract]

Summary of the Notes and related discounts

Risk-free interest rate %	0.34 – 0.48
Expected dividend yield	—
Expected term - years (contractual term)	0.33 – 0.59
Forfeiture rate	—
Expected volatility %	112
Timing of down-round triggering event	October 2016

Schedule of assumptions for embedded converstion feature valuation

	Original Value		Loss on Early Extinguishment of Bridge Loans			Secured Convertible Notes, net
Cash and other proceeds received from financing		—		—		$	5,148,620
Warrants	$	2,147,574		(831,109	)		(1,316,465	)
Embedded conversion feature in notes	$	3,173,896		(1,312,851	)		(1,861,045	)
Financing costs		—		—			(552,391	)
Amortization of debt discount		—		—			1,830,012
Totals, net	$	5,321,470	$	(2,143,960	)	$	3,248,731

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DERIVATIVE LIABILITIES (Tables)

9 Months Ended

Sep. 30, 2016

Derivative Instruments and Hedging Activities Disclosure [Abstract]

Derivative warrant liability

	09/30/16			12/31/15
Derivative liabilities as of January 1	$	127,000		$	208,155
Secured convertible note derivatives:
Warrants		2,147,574			—
Embedded conversion feature in Notes		3,173,896			—
Loss (gain) on revaluation		(4,437,776	)		(81,155	)
Derivative liabilities as of end of period	$	1,010,694		$	127,000

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EQUITY COMPENSATION PLANS (Tables)

9 Months Ended

Sep. 30, 2016

Equity Compensation Plans

EQUITY COMPENSATION PLANS

	Equity Compensation Plans						Not Pursuant
	2003 Plan			2008 Plan			to a Plan
Shares Available For Issuance
Total reserved for stock options and restricted stock		160,000			10,000,000
Net restricted stock issued net of cancellations		(5,000	)		(288,866	)
Stock options granted		(154,449	)		(4,293,693	)
Add back options cancelled before exercise		92,349			1,866,628
Less shares no longer available due to Plan expiration		(92,900	)		—
Remaining shares available for future grants at September 30, 2016		—			7,284,069

Stock options granted		154,449			4,293,693			310,000
Less: Stock options cancelled		(92,349	)		(1,866,628	)		(243,333	)
Stock options exercised		(35,600	)		(23,500	)		(66,667	)
Net shares outstanding before restricted stock		26,500			2,403,565			—
Net restricted stock issued net of cancellations		5,000			288,866			6,485
Outstanding shares at September 30, 2016		31,500			2,692,431			6,485

XML 35 R24.htm IDEA: XBRL DOCUMENT

STOCK OPTIONS (Tables)

9 Months Ended

Sep. 30, 2016

Stock Options

Assumption used for stock option granted

	2016		2015
Risk-free interest rate %		0.18 – 1.07		1.46 – 1.90
Expected dividend yield		—		—
Expected term - years		.25 – 4		5 – 5.5
Forfeiture rate % (excluding fully vested stock options)		2 – 5		7.5 - 15
Expected volatility %		0.94 – 1.28		0.92 – 0.93

Stock option activity

Stock Options	Shares			Weighted- Average Exercise Price		Weighted- Average Remaining Contractual Term (years)		Aggregate Intrinsic Value
Outstanding options at January 1, 2016		1,667,233		$	2.01
Granted		1,222,810		$	1.28
Exercised		(10,500	)	$	1.19
Forfeited or expired		(449,478	)	$	2.47
Outstanding options at September 30, 2016		2,430,065		$	1.56		8.63	$	—
Exercisable options at September 30, 2016		1,622,072		$	1.59		8.48	$	—

XML 36 R25.htm IDEA: XBRL DOCUMENT

RESTRICTED STOCK (Tables)

9 Months Ended

Sep. 30, 2016

Restricted Stock

Nonvested restricted stock activity

Restricted Stock	Shares			Weighted- Average Grant-Date Fair Value
Non-vested shares at January 1, 2016		27,842		$	13.06
Granted		280,000		$	1.13
Vested		(2,020	)	$	8.68
Forfeited		(5,471	)	$	7.67
Non-vested shares at September 30, 2016		300,351		$	2.07

XML 37 R26.htm IDEA: XBRL DOCUMENT

WARRANTS (Tables)

9 Months Ended

Sep. 30, 2016

Warrants

Warrant Activity

Warrants	Shares		Weighted- Average Exercise Price
Outstanding warrants at January 1, 2016		4,530,428	$	3.68
Granted		3,552,875	$	1.50
Forfeited		—	$	—
Outstanding warrants at September 30, 2016		8,083,303	$	2.72

Outstanding Warrants

Type of Warrant/Range of Exercise Prices				Expirations		Number Outstanding		Weighted-Average RemainingContractual Life (years)		Weighted- Average Exercise Price		Number Exercisable
Derivative:
		$	1.50		7/29/21		1,274,280		4.83	$	1.50	1,274,280
		$	1.50		5/3/18		2,278,595		1.59	$	1.50	2,278,595
		$	7.50		8/31/17 to 11/6/17		700,000		0.97	$	7.50	700,000
Equity:
	$		2.75 - $3.00		12/10/18 to 10//30/20		3,830,428		3.44	$	2.98	3,830,428
Total outstanding					8,083,303							8,083,303

Warrants assumptions utilized by the Company

By expiration:		7/29/21		5/3/18			8/31/17 - 11/6/17
Risk-free interest rate %			1.03		0.56			0.73
Expected dividend yield			—		—			—
Expected term - years (contractual term)			5.15		1.87			1.17 - 1.35
Forfeiture rate			—		—			—
Expected volatility %			103		103			84.95
Timing of down-round triggering event	August 2016		August 2016			N/A

- Definition

Tabular disclosure of warrants or rights issued. Warrants and rights outstanding are derivative securities that give the holder the right to purchase securities (usually equity) from the issuer at a specific price within a certain time frame. Warrants are often included in a new debt issue to entice investors by a higher return potential. The main difference between warrants and call options is that warrants are issued and guaranteed by the company, whereas options are exchange instruments and are not issued by the company. Also, the lifetime of a warrant is often measured in years, while the lifetime of a typical option is measured in months. Disclose the title of issue of securities called for by warrants and rights outstanding, the aggregate amount of securities called for by warrants and rights outstanding, the date from which the warrants or rights are exercisable, and the price at which the warrant or right is exercisable.

+ References + Details

XML 38 R27.htm IDEA: XBRL DOCUMENT

LIQUIDITY AND MANAGEMENT'S PLANS (Details Narrative) - USD ($)	Sep. 30, 2016	Dec. 31, 2015
Liquidity And Managements Plans
Cash	$ 172,725
Working capital deficit	(6,865,405)
Accumulated deficit	$ (154,897,838)	$ (150,129,933)

XML 39 R28.htm IDEA: XBRL DOCUMENT

PROPERTY AND EQUIPMENT (Details) - USD ($)	9 Months Ended
PROPERTY AND EQUIPMENT (Details) - USD ($)	Sep. 30, 2016	Dec. 31, 2015
Total property and equipment	$ 1,274,410	$ 1,293,555
Less accumulated depreciation and amortization	1,085,474	1,025,884
Property and equipment, net	188,936	267,671
Computer Equipment [Member]
Total property and equipment	$ 335,298	332,764
Estimated Useful Lives	3 years
Office and laboratory equipment [Member]
Total property and equipment	$ 603,226	628,726
Office and laboratory equipment [Member] \| Minimum [Member]
Estimated Useful Lives	3 years
Office and laboratory equipment [Member] \| Maximum [Member]
Estimated Useful Lives	5 years
Furniture and fixtures [Member]
Total property and equipment	$ 228,099	228,099
Estimated Useful Lives	7 years
Manufacturing equipment [Member]
Total property and equipment	$ 65,819	61,998
Estimated Useful Lives	5 years
Leasehold improvements [Member]
Total property and equipment	$ 41,968	$ 41,968
Leasehold improvements [Member] \| Minimum [Member]
Estimated Useful Lives	3 years
Leasehold improvements [Member] \| Maximum [Member]
Estimated Useful Lives	7 years

XML 40 R29.htm IDEA: XBRL DOCUMENT

CAPITALIZED SOFTWARE DEVELOPMENT COSTS (Details Narrative) - USD ($)	3 Months Ended	9 Months Ended
	Sep. 30, 2016	Sep. 30, 2016
Capitalized Software Development Costs
Costs associated with the application programming	$ 25,170	$ 267,811

XML 41 R30.htm IDEA: XBRL DOCUMENT

FINANCING TRANSACTIONS (Details)	9 Months Ended
FINANCING TRANSACTIONS (Details)	Sep. 30, 2016 USD ($)
Debt Disclosure [Abstract]
Cash and other proceeds received from financing	$ 5,148,620
Financing costs	(552,391)
Warrants	(1,316,465)
Embedded conversion feature in Notes	(1,861,045)
Amortization of debt discount	1,830,012
Secured convertible notes, net	$ 3,248,731

XML 42 R31.htm IDEA: XBRL DOCUMENT

FINANCING TRANSACTIONS (Details 1)	9 Months Ended
FINANCING TRANSACTIONS (Details 1)	Sep. 30, 2016 USD ($)
STOCK OPTIONS AND RESTRICTED STOCK
Risk-free interest rate minimum	0.34%
Risk-free interest rate maximum	0.48%
Expected dividend yield	$ 0
Forfeiture rate	0.00%
Expected volatility	112.00%
Timing of down-round triggering event	October 2016
Minimum [Member]
STOCK OPTIONS AND RESTRICTED STOCK
Expected term - years	3 months 29 days
Maximum [Member]
STOCK OPTIONS AND RESTRICTED STOCK
Expected term - years	7 months 2 days

XML 43 R32.htm IDEA: XBRL DOCUMENT

FINANCING TRANSACTIONS (Details Narrative) - USD ($)	Sep. 30, 2016	Dec. 31, 2015
Debt Disclosure [Abstract]
Bridge loans	$ 250,000	$ 330,000

XML 44 R33.htm IDEA: XBRL DOCUMENT

DERIVATIVE LIABILITY (Details) - USD ($)	9 Months Ended	12 Months Ended
DERIVATIVE LIABILITY (Details) - USD ($)	Sep. 30, 2016	Dec. 31, 2015
Derivative Instruments and Hedging Activities Disclosure [Abstract]
Derivative warrant liability as of January 1	$ 127,000	$ 208,155
Warrants	2,147,574	0
Embedded conversion feature in Notes	3,173,896	0
Loss (gain) on revaluation	(4,437,776)	(81,155)
Derivative liabilities as of end of period	$ 1,010,694	$ 127,000

XML 45 R34.htm IDEA: XBRL DOCUMENT

NET LOSS PER SHARE (Details Narrative)	3 Months Ended
NET LOSS PER SHARE (Details Narrative)	Sep. 30, 2016 USD ($) shares
Net Loss Per Share
Antidilutive securities \| shares	5,657,824
Net (loss) in fair value of derivative \| $	$ (2,720,727)

XML 46 R35.htm IDEA: XBRL DOCUMENT

EQUITY COMPENSATION PLANS (Details)	9 Months Ended
EQUITY COMPENSATION PLANS (Details)	Sep. 30, 2016 USD ($) shares
Shares Available For Issuance
Add back options cancelled before exercise	(449,478)
Plan2003Member
Shares Available For Issuance
Total reserved for stock options and restricted stock \| $	$ 160,000
Net restricted stock issued net of cancellations \| $	$ (5,000)
Stock options granted	(154,449)
Add back options cancelled before exercise	92,349
Less shares no longer available due to Plan expiration \| $	$ (92,900)
Remaining shares available for future grants at September 30, 2016	0
Outstanding Options and Restricted Stock
Stock options granted \| $	$ 154,449
Less: Stock options cancelled \| $	$ (92,349)
Stock options exercised	(35,600)
Net shares outstanding before restricted stock	26,500
Net restricted stock issued net of cancellations	5,000
Outstanding shares at September 30, 2016	31,500
Plan2008Member
Shares Available For Issuance
Total reserved for stock options and restricted stock \| $	$ 10,000,000
Net restricted stock issued net of cancellations \| $	$ (288,866)
Stock options granted	(4,293,693)
Add back options cancelled before exercise	1,866,628
Less shares no longer available due to Plan expiration \| $	$ 0
Remaining shares available for future grants at September 30, 2016	7,284,069
Outstanding Options and Restricted Stock
Stock options granted \| $	$ 4,293,693
Less: Stock options cancelled \| $	$ (1,866,628)
Stock options exercised	(23,500)
Net shares outstanding before restricted stock	2,403,565
Net restricted stock issued net of cancellations	288,866
Outstanding shares at September 30, 2016	2,692,431
Not Pursuant to a Plan [Member]
Outstanding Options and Restricted Stock
Stock options granted \| $	$ 310,000
Less: Stock options cancelled \| $	$ (243,333)
Stock options exercised	(66,667)
Net shares outstanding before restricted stock	0
Net restricted stock issued net of cancellations	6,485
Outstanding shares at September 30, 2016	6,485

XML 47 R36.htm IDEA: XBRL DOCUMENT

EQUITY COMPENSATION PLANS (Details Narrative) - shares	Sep. 30, 2016	Dec. 31, 2015
Restricted stock	300,351	27,842
Options to purchase an aggregate of shares	1,622,072
Maximun share authorized	150,000,000	150,000,000
Plan2003Member
Restricted stock	5,000
Options to purchase an aggregate of shares	26,500
Shares available for future grant	0
Plan2008Member
Restricted stock	288,866
Options to purchase an aggregate of shares	2,403,565
Shares available for future grant	7,284,069
Maximun share authorized	10,000,000

XML 48 R37.htm IDEA: XBRL DOCUMENT

STOCK OPTIONS (Details) - USD ($)	9 Months Ended
STOCK OPTIONS (Details) - USD ($)	Sep. 30, 2016	Sep. 30, 2015
STOCK OPTIONS AND RESTRICTED STOCK
Risk-free interest rate minimum	0.34%
Risk-free interest rate maximum	0.48%
Expected dividend yield	$ 0
Forfeiture rate (excluding fully vested stock options)	0.00%
Expected volatility	112.00%
Director [Member]
STOCK OPTIONS AND RESTRICTED STOCK
Risk-free interest rate minimum	0.18%	1.46%
Risk-free interest rate maximum	1.07%	1.90%
Expected dividend yield	$ 0	$ 0
Minimum [Member]
STOCK OPTIONS AND RESTRICTED STOCK
Expected term - years	3 months 29 days
Minimum [Member] \| Director [Member]
STOCK OPTIONS AND RESTRICTED STOCK
Expected term - years	3 months	5 years
Forfeiture rate (excluding fully vested stock options)	2.00%	7.50%
Expected volatility	0.94%	0.92%
Maximum [Member]
STOCK OPTIONS AND RESTRICTED STOCK
Expected term - years	7 months 2 days
Maximum [Member] \| Director [Member]
STOCK OPTIONS AND RESTRICTED STOCK
Expected term - years	4 years	5 years 6 months
Forfeiture rate (excluding fully vested stock options)	5.00%	15.00%
Expected volatility	1.28%	0.93%

XML 49 R38.htm IDEA: XBRL DOCUMENT

STOCK OPTIONS (Details1)	9 Months Ended
STOCK OPTIONS (Details1)	Sep. 30, 2016 USD ($) $ / shares shares
Shares
Beginning Balance \| shares	1,667,233
Granted \| shares	1,222,810
Exercised \| $	$ (10,500)
Forfeited or expired \| shares	(449,478)
Ending Balance \| shares	2,430,065
Exercisable at September 30, 2016 \| shares	1,622,072
Weighted-Average Exercise Price
Beginning Balance	$ 2.01
Weighted-average stock options granted	1.28
Exercised	1.19
Forfeited or expired	2.47
Ending Balance	1.56
Exercisable at September 30, 2016	$ 1.59
Weighted-Average Remaining Contractual Term
Outstanding remaining term	8 years 7 months 17 days
Exercisable remaining term	8 years 5 months 23 days
Aggregate Intrinsic Value
Beginning Balance \| $	$ 0
Ending Balance \| $	$ 0

XML 50 R39.htm IDEA: XBRL DOCUMENT

STOCK OPTIONS (Details Narrative) - USD ($)	9 Months Ended
STOCK OPTIONS (Details Narrative) - USD ($)	Sep. 30, 2016	Sep. 30, 2015
Stock Options
Additional paid-in capital	$ 521,494	$ 756,000
Unrecognized compensation expense related to non	$ 435,072
Granted	$ 1.28

XML 51 R40.htm IDEA: XBRL DOCUMENT

RESTRICTED STOCK (Details)	9 Months Ended
RESTRICTED STOCK (Details)	Sep. 30, 2016 $ / shares shares
Shares
Non-vested shares at January 1, 2016 \| shares	27,842
Granted \| shares	280,000
Vested \| shares	(2,020)
Forfeited \| shares	(5,471)
Non-vested shares at June 30, 2016 \| shares	300,351
Weighted- Average Grant-DateFair Value
Non-vested shares at January 1, 2016 \| $ / shares	$ 13.06
Granted \| $ / shares	1.13
Vested \| $ / shares	8.68
Forfeited \| $ / shares	7.67
Non-vested shares at June 30, 2016 \| $ / shares	$ 2.07

XML 52 R41.htm IDEA: XBRL DOCUMENT

RESTRICTED STOCK (Details Narrative) - USD ($)

9 Months Ended

Sep. 30, 2016

Sep. 30, 2015

Restricted Stock

Non-cash restricted stock compensation expense

$ 181,369

$ 42,000

Vesting criteria

Among the 300,351 shares of non-vested restricted stock, the various vesting criteria include the following:

●	14,185 shares of restricted stock vest upon the FDA approval of the Company’s CGM system or the sale of the Company; and
●	6,166 shares of restricted stock vest over 4 years, at each of the anniversary dates of the grants, and

●	130,000 shares of restricted stock vest 18 months from the date of issuance, and
●	150,000 shares of restricted stock vest quarterly after the company receives debt/equity financing of at least $1 million

Unrecognized compensation expense

$ 438,429

XML 53 R42.htm IDEA: XBRL DOCUMENT

WARRANTS (Details)	9 Months Ended
WARRANTS (Details)	Sep. 30, 2016 $ / shares shares
Shares
Outstanding warrants at January 1, 2016 \| shares	4,530,428
Granted \| shares	3,552,875
Forfeited \| shares	0
Outstanding warrants at September 30, 2016 \| shares	8,083,303
Weighted-Average Exercise Price
Outstanding warrants at January 1, 2016 \| $ / shares	$ 3.68
Granted \| $ / shares	1.50
Forfeited \| $ / shares	0
Outstanding warrants at September 30, 2016 \| $ / shares	$ 2.72

XML 54 R43.htm IDEA: XBRL DOCUMENT

WARRANTS (Details 1)	9 Months Ended
WARRANTS (Details 1)	Sep. 30, 2016 $ / shares shares
Warrants
Number Outstanding	8,083,303
Weighted-Average Exercise price \| $ / shares	$ 1.13
Number Exercisable	8,083,303
Derivative: $7.50 [Member]
Warrants
Exercise Price \| $ / shares	$ 7.50
Expirations	8-31-17 to 11-6-17
Number Outstanding	700,000
Weighted- Average Remaining Contractual Life (years)	7 years 6 months
Weighted-Average Exercise price \| $ / shares	$ 7.50
Number Exercisable	700,000
Derivative: $1.50 [Member]
Warrants
Exercise Price \| $ / shares	$ 1.50
Expirations	7-29-2021
Number Outstanding	1,274,280
Weighted- Average Remaining Contractual Life (years)	4 years 9 months 29 days
Weighted-Average Exercise price \| $ / shares	$ 1.50
Number Exercisable	1,274,280
Derivative: $1.50 [Member]
Warrants
Exercise Price \| $ / shares	$ 1.50
Expirations	5-30-2018
Number Outstanding	2,278,595
Weighted- Average Remaining Contractual Life (years)	1 year 7 months 2 days
Weighted-Average Exercise price \| $ / shares	$ 1.50
Number Exercisable	2,278,595

XML 55 R44.htm IDEA: XBRL DOCUMENT

WARRANTS (Details 2)	9 Months Ended
WARRANTS (Details 2)	Sep. 30, 2016
Forfeiture rate	0.00%
Expected volatility	112.00%
Timing of down-round triggering event	October 2016
8/31/17 - 11/6/17 [Member]
Risk-free interest rate	0.73%
Expected dividend yield	0.00%
Forfeiture rate	0.00%
Expected volatility	84.95%
Timing of down-round triggering event	N/A
7/29/21 [Member]
Risk-free interest rate	1.03%
Expected dividend yield	0.00%
Expected term (contractual term)	5 years 1 month 24 days
Forfeiture rate	0.00%
Expected volatility	103.00%
Timing of down-round triggering event	August 2016
5/3/18 [Member]
Risk-free interest rate	0.56%
Expected dividend yield	0.00%
Expected term (contractual term)	1 year 10 months 13 days
Forfeiture rate	0.00%
Expected volatility	103.00%
Timing of down-round triggering event	August 2016
Minimum [Member]
Expected term (contractual term)	3 months 29 days
Minimum [Member] \| 8/31/17 - 11/6/17 [Member]
Expected term (contractual term)	1 year 2 months 1 day
Maximum [Member]
Expected term (contractual term)	7 months 2 days
Maximum [Member] \| 8/31/17 - 11/6/17 [Member]
Expected term (contractual term)	1 year 4 months 6 days

XML 56 R45.htm IDEA: XBRL DOCUMENT

WARRANTS (Details Narrative)	9 Months Ended
WARRANTS (Details Narrative)	Sep. 30, 2016 shares
Warrants
Warrants issued to purchase shares	3,552,875

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