0001511164-17-000550.txt : 20170905 0001511164-17-000550.hdr.sgml : 20170904 20170905153854 ACCESSION NUMBER: 0001511164-17-000550 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20170905 ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20170905 DATE AS OF CHANGE: 20170905 FILER: COMPANY DATA: COMPANY CONFORMED NAME: BIOTRICITY INC. CENTRAL INDEX KEY: 0001630113 STANDARD INDUSTRIAL CLASSIFICATION: SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841] IRS NUMBER: 472548273 STATE OF INCORPORATION: NV FISCAL YEAR END: 0331 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 333-201719 FILM NUMBER: 171068626 BUSINESS ADDRESS: STREET 1: 75 INTERNATIONAL BLVD., SUITE 300 CITY: TORONTO STATE: A6 ZIP: M9W 6L9 BUSINESS PHONE: (416) 214-3678 MAIL ADDRESS: STREET 1: 75 INTERNATIONAL BLVD., SUITE 300 CITY: TORONTO STATE: A6 ZIP: M9W 6L9 FORMER COMPANY: FORMER CONFORMED NAME: METASOLUTIONS, INC. DATE OF NAME CHANGE: 20150107 8-K 1 form8k9517biotricity.htm FORM 8-K Converted by EDGARwiz





UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 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): September 5, 2017


BIOTRICITY, INC.

(Exact Name of Registrant as Specified in Its Charter)


Nevada

 

333-201719

 

47-2548273

(State or Other Jurisdiction of Incorporation or Organization)

 

(Commission File Number)

 

(IRS Employer Identification No.)


275 Shoreline Drive, Suite 150

Redwood City, California 94065

 


94065

(Address of Principal Executive Offices)

 

(Zip Code)

Registrant’s Telephone Number, Including Area Code: (416) 214-3678

 

(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 registrant under any of the following provisions (see General Instruction A.2. below):


o

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

 

 

o

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

 

 

o

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

 

 

o

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

 

 

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company

x

 

 

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  x










Item 7.01

Regulation FD Disclosure

On September 5, 2017, Biotricity, Inc. issued a press release announcing that it has received comments from the FDA on its hardware 510(k) submission.


A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference. The information in this Item 7.01 and in Item 9.01 of this report (including Exhibit 99.1) is being furnished pursuant to Item 7.01 and shall not be deemed to be “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section. This report will not be deemed an admission as to the materiality of any information herein (including Exhibit 99.1).


Item 9.01

Financial Statements and Exhibits


(d) Exhibits. The exhibit listed in the following Exhibit Index is furnished as part of this Current Report on Form 8-K:

 

 

 

Exhibit

 

Description

99.1

 

Press release




2






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:  September 5, 2017

 

 

 

BIOTRICITY, INC.

 

 

 

 

 

 

By:

/s/ Waqaas Al-Siddiq

 

 

 

Waqaas Al-Siddiq

 

 

 

Chief Executive Officer

 





3



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FOR IMMEDIATE RELEASE


Biotricity FDA Submission Update


REDWOOD CITY, CA – September 5, 2017 – Biotricity, Inc. (OTCQB: BTCY), a medical diagnostic and consumer healthcare technology company dedicated to delivering innovative, biometric remote monitoring solutions, is pleased to announce that it has received comments from the FDA on its hardware 510(k) submission. The FDA is requesting that Biotricity conduct additional biocompatibility testing of the external pouch used by patients to carry the Bioflux device. Biotricity is confident in the material utilized since it has previously passed cytotoxicity testing, which was conducted in accordance with FDA guidelines. Biotricity has begun the testing process, but is prepared to change the material, if required. Testing typically takes 6 to 8 weeks and is being conducted at an independent lab.


The premarket 510(k) notification process is an interactive process with reviewers who use manufacturer evidence to assess the substantial equivalence of the new device, relying on FDA guidance documents and recognized safety standards, as well as the equivalence of this device to devices that have previously been commercialized.


In conjunction with the 510(k) submission process, Biotricity has begun working with its manufacturers to prepare for initial device production, in concert with the logistics and timing of its anticipated product launch. Management is enthusiastic about the upcoming few months, proud of Biotricity’s development thus far, and believes the company is well positioned to focus on its upcoming launch program.


About Biotricity Inc.

Biotricity is a modern medical technology company focused on delivering innovative, remote biometric monitoring solutions to the medical and consumer markets, including diagnostic and post-diagnostic solutions for chronic conditions and lifestyle improvement. Biotricity’s R&D continues to focus on the preventative healthcare market, with a vision of putting health management into the hands of the individual. The company aims to support the self-management of critical and chronic conditions with the use of innovative solutions to ease the growing burden on the healthcare system. To learn more, visit www.biotricity.com.




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Important Cautions Regarding Forward-Looking Statements

Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements. Forward-looking statements, which involve assumptions and describe our future plans, strategies, and expectations, are generally identifiable by use of the words “may,” “should,” “would,” “will,” “could,” “scheduled,” “expect,” “anticipate,” “estimate,” “believe,” “intend,” “seek,” or “project” or the negative of these words or other variations on these words or comparable terminology. Forward-looking statements may include, without limitation, statements regarding (i) the plans and objectives of management for future operations, including plans or objectives relating to the design, development and commercialization of Bioflux or any of the Company’s other proposed products or services, (ii) a projection of income (including income/loss), earnings (including earnings/loss) per share, capital expenditures, dividends, capital structure or other financial items, (iii) the Company's future financial performance, (iv) the regulatory regime in which the Company operates or intends to operate and (v) the assumptions underlying or relating to any statement described in points (i), (ii), (iii) or (iv) above. Such forward-looking statements are not meant to predict or guarantee actual results, performance, events or circumstances and may not be realized because they are based upon the Company's current projections, plans, objectives, beliefs, expectations, estimates and assumptions and are subject to a number of risks and uncertainties and other influences, many of which the Company has no control over. Actual results and the timing of certain events and circumstances may differ materially from those described by the forward-looking statements as a result of these risks and uncertainties. Factors that may influence or contribute to the inaccuracy of the forward-looking statements or cause actual results to differ materially from expected or desired results may include, without limitation, the Company's inability to obtain additional financing, the significant length of time and resources associated with the development of its products and related insufficient cash flows and resulting illiquidity, the Company's inability to expand the Company's business, significant government regulation of medical devices and the healthcare industry, lack of product diversification, existing or increased competition, results of arbitration and litigation, stock volatility and illiquidity, and the Company's failure to implement the Company's business plans or strategies. These and other factors are identified and described in more detail in the Company's filings with the SEC. The Company assumes no obligation to update any forward-looking statements in order to reflect any event or circumstance that may arise after the date of this release.


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Media Contacts

McCoin & Smith Communications Inc.

Chris McCoin,

Chris@mccoinsmith.com, 508-429-5988

Richard Smith,

rick@mccoinsmith.com, 978-433-3304


Investor Relations:

Biotricity, Inc.

investors@biotricity.com




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