8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of report (Date of earliest event reported):  June 10, 2013

Echo Therapeutics, Inc.

 (Exact name of Company as specified in its charter)

Delaware	000-23017	41-1649949
(State or other jurisdiction of Incorporation)	(Commission File Number)	(I.R.S. Employer Identification No.)
8 Penn Center 1628 JFK Blvd., Suite 300 Philadelphia, PA		19103
(Address of principal executive offices)		(Zip Code)

Company’s telephone number, including area code: (215) 717-4100

 (Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the Company under any of the following provisions (see General Instruction A.2. below):

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Item 8.01.   Other Events.

 On June 10, 2013, Echo Therapeutics, Inc. (the “Company”) issued a press release announcing its submission to the FDA of a pre-submission package for the Symphony® CGM System.  A copy of the press release is attached as Exhibit 99.1 to this report.

Item 9.01.   Financial Statements and Exhibits.

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

SIGNATURES

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

	ECHO THERAPEUTICS, INC.
Dated: June 10, 2013	By:  /s/  Patrick T. Mooney
	Patrick T. Mooney
	President and Chief Executive Officer

EXHIBIT INDEX

Exhibit No.	Description
99.1	Press Release issued by the Company on June 10, 2013.

EX-99.1

Exhibit 99.1

Echo Therapeutics Submits Pre-Submission Package to FDA for Symphony® CGM System

Philadelphia, PA – June 10, 2013 – Echo Therapeutics, Inc. (Nasdaq: ECTE), a company developing its needle-free Symphony® CGM System as a non-invasive, wireless continuous glucose monitoring system, today announced that it has submitted a pre-submission package to the U.S. Food and Drug Administration (FDA) for the Symphony CGM System for use in the hospital critical care environment.  In conjunction with the pre-submission package, the Company has requested a meeting with the FDA to work cooperatively on the clinical and regulatory plan to support FDA approval of the System.

 “As the Company now begins to sharpen its focus on gaining FDA approval, we are committed to obtaining as much FDA input and agreement as possible regarding the design of the pivotal trial.  The pre-submission with the FDA is a significant milestone on our path to advance Symphony towards U.S. commercialization.  Following the feedback we expect to receive from our meeting with the FDA, we plan to initiate the pivotal U.S. clinical trial for Symphony,” stated Patrick T. Mooney, M.D., Chairman and CEO of Echo Therapeutics.  “Hospital-based continuous glucose monitoring remains a significant unmet need and, to our knowledge, no CGM has yet been cleared or approved by the FDA specifically for use in critical care units.  We will continue to work diligently to complete the clinical and regulatory requirements to pursue this unmet medical need and to make Symphony available to clinicians as quickly as possible. ”

The pre-submission documentation has been submitted to the FDA in order to obtain the Agency’s guidance regarding the U.S. regulatory pathway for Symphony, the proper approach to refining the pivotal trial protocol and endpoints, and preparing the pre-marketing application.

The FDA’s Pre-Submission Program is intended to allow applicants the opportunity to obtain targeted FDA feedback in response to specific questions related to product development, including planned non-clinical evaluations, proposed clinical study protocols, or data requirements, prior to making a submission to the Agency.  For more information on the Pre-Submission Program, visit the FDA website at http://www.fda.gov.

About Echo Therapeutics

Echo Therapeutics is developing the Symphony CGM System as a non-invasive, wireless continuous glucose monitoring system.  Our target is patients who could benefit from glucose monitoring in the hospital setting, including critical care.  Significant opportunity also exists for patients with diabetes to use Symphony in the outpatient setting.  Echo is also developing its needle-free skin preparation component of Symphony, the Prelude® SkinPrep System, as a platform technology to enhance drug delivery of topical pharmaceuticals.

Cautionary Statement Regarding Forward Looking Statements

The statements in this press release that are not historical facts may constitute forward-looking statements including, without limitation, the statement regarding our plan to initiate the pivotal U.S. clinical trial for Symphony, that are based on current expectations and are subject to risks and uncertainties that could cause actual future results to differ materially from those expressed or implied by such statements. Those risks and uncertainties include, but are not limited to, risks related to regulatory approvals and the success of Echo's ongoing studies, including the safety and efficacy of Echo's Symphony CGM System, the failure of future development and preliminary marketing efforts related to Echo's Symphony CGM System, Echo's ability to secure additional commercial partnering arrangements, risks and uncertainties relating to Echo's and its partners' ability to develop, market and sell the Symphony CGM System, the availability of substantial additional equity or debt capital to support its research, development and product commercialization activities, and the success of its research, development, regulatory approval, marketing and distribution plans and strategies, including those plans and strategies related to its Symphony CGM System. These and other risks and uncertainties are identified and described in more detail in Echo's filings with the Securities and Exchange Commission, including, without limitation, its Annual Report on Form 10-K for the year ended December 31, 2012, its Quarterly Reports on Form 10-Q, and its Current Reports on Form 8-K. Echo undertakes no obligation to publicly update or revise any forward-looking statements.

For More Information:

Christine H. Olimpio

Director, Investor Relations and Corporate Communications

(215) 717-4104

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