Current Report Filing (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): September 18, 2017

HTG Molecular Diagnostics, Inc.

(Exact name of registrant as specified in its charter)



Delaware	001-37369	86-0912294
(State or other jurisdiction of incorporation)	(Commission File Number)	(IRS Employer Identification No.)

3430 E. Global Loop Tucson, AZ		85706
(Address of principal executive offices)		(Zip Code)

Registrant’s telephone number, including area code: (877) 289-2615

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligations of the registrant under any of the following provisions:


☐	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))

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 ☒

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. ☒

Item 8.01

Other Events.

On September 18, 2017, HTG Molecular Diagnostics, Inc. (the “Company”) announced in a press release that it has successfully completed an audit of its Quality Management System for continued certification to ISO 13485. This certification was issued by a registrar accredited under the Canadian Medical Device Conformity Assessment System (CMDCAS), which is required by Health Canada for the Company to market in vitro diagnostic (IVD) products in Canada.

ISO 13485 is an internationally recognized quality standard certification that is required of medical device manufacturers by various authorities worldwide to demonstrate each manufacturer has a quality management system in place to consistently meet customer and regulatory requirements for the design, development, and commercialization of medical devices. The Company was first certified to ISO 13485 in 2012 and was recertified in 2015.

Forward Looking Statements

Statements contained in this report regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements about the benefits of the Company’s Quality Management System and its ISO 13485 continued certification. Words such as "believes," "anticipates," "plans," "expects," "intends," "will," "goal," "potential" and similar expressions are intended to identify forward-looking statements, though not all forward-looking statements necessarily contain these identifying words. These forward-looking statements are based upon management's current expectations, are subject to known and unknown risks, and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, including, without limitation, the Company’s ability to successfully develop, market and/or commercialize its products, including the Company’s ability to satisfy its customers’ product-quality requirements, or to obtain or maintain regulatory approvals for its products in Canada or any other jurisdiction. These and other factors are described in greater detail in the Company’s filings with the Securities and Exchange Commission, including without limitation its Quarterly Report on Form 10‑Q for the quarter ended June 30, 2017. All forward-looking statements contained in this report speak only as of the date on which they were made, and the Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

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 hereunto duly authorized.



	HTG Molecular Diagnostics, Inc.

Dated: September 18, 2017	By:	/s/ Shaun D. McMeans
		Shaun D. McMeans
		Vice President of Finance and Administration and Chief Financial Officer