8-K 1 hsdt-8k_20180904.htm 8-K hsdt-8k_20180904.htm

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

 

September 4, 2018

Date of Report (Date of earliest event reported)

 

HELIUS MEDICAL TECHNOLOGIES, INC.
(Exact name of registrant as specified in its charter)

 

DELAWARE

001-38445

36-4787690

(State or other jurisdiction of

(Commission

(I.R.S. Employer

incorporation or organization)

File Number)

Identification No.)

 

(Exact name of registrant as specified in charter)

 

 

642 Newtown Yardley Road, Suite 100

Newtown, Pennsylvania, 18940

(Address of principal executive offices) (Zip Code)

 

Registrant’s telephone number, including area code: (215) 944-6100

 

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:

 

 

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

 

Soliciting material pursuant to Rule 14a­12 under the Exchange Act (17 CFR 240.14a­12)

 

Pre­commencement communications pursuant to Rule 14d­2(b) under the Exchange Act (17 CFR 240.14d­2(b))

 

Pre­commencement communications pursuant to Rule 13e­4(c) under the Exchange Act (17 CFR 240.13e­4(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

 

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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

 

 

 

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Item 7.01 

Regulation FD Disclosure

 

On September 4, 2018, Helius Medical Technologies, Inc. (the “Company”) issued a press release announcing the submission of a request to the U.S. Food and Drug Administration (“FDA”) for de novo classification and 510(k) clearance for the Portable Neuromodulation Stimulator (“PoNS®”) device with the FDA.  A copy of the press release is furnished herewith as Exhibit 99.1.

 

The information set forth in this Item 7.01 and in the press release attached hereto as Exhibit 99.1, is deemed to be “furnished” and shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section.  The information set forth in this Item 7.01, including Exhibit 99.1, shall not be deemed incorporated by reference into any filing under the Exchange Act or the Securities Act of 1933, as amended, except to the extent that the Company specifically incorporates it by reference.

 

Item 9.01.Financial Statements and Exhibits.

 

(d) Exhibits

 

Exhibit

 

 

 

Number

 

Exhibit Description

99.1

 

Press release dated September 4, 2018


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SIGNATURE

 

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.

 

HELIUS MEDICAL TECHNOLOGIES, INC.

 

  

  

Dated:  September 4, 2018

By:

/s/ Joyce LaViscount

 

  

Joyce LaViscount, Chief Financial Officer

 

  

 

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