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

January 11, 2021

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 Incorporation)

(Commission File Number)

(IRS Employer

Identification No.)

 

 

 

642 Newtown Yardley Road, Suite 100

Newtown, PA

 

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 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))

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class

 

Trading

Symbol(s)

 

Name of each exchange on which registered

Common Stock

 

HSDT

 

The Nasdaq Stock Market LLC

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 7.01 Regulation FD.

 

On January 11, 2021, Helius Medical Technologies, Inc. (the “Company”) issued a press release announcing its submission of a response to the U.S. Food and Drug Administration in pursuit of de novo classification and clearance of the Portable Neuromodulation Stimulator (PoNS™) device for the treatment of gait deficit due to symptoms of Multiple Sclerosis. A copy of the press release is attached hereto as Exhibit 99.1.

 

The information in this Item 7.01, including Exhibit 99.1 attached hereto, is being furnished, shall not be deemed “filed” for any purpose, and shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, except as expressly set forth by specific reference in such a filing.

 

Item 8.01 Other Events.

 

On January 11, 2021, the Company announced that it has submitted its formal response to the U.S. Food and Drug Administration’s request for additional information received in October 2020, which related to the Company’s request for de novo classification and clearance of the PoNS™ device as a potential treatment for gait deficit due to symptoms of Multiple Sclerosis, to be used as an adjunct to a supervised therapeutic exercise program in patients over 18 years of age.

 

Item 9.01 Financial Statements and Exhibits.

 

(d) Exhibits.

 

Exhibit

 

Description

99.1 

 

Press Release, dated January 11, 2021.

 


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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.

 

 

 

HELIUS MEDICAL TECHNOLOGIES, INC.

 

 

 

 

Date: January 11, 2021

 

By:

/s/ Joyce LaViscount

 

 

 

Joyce LaViscount

 

 

 

Chief Financial Officer, Chief Operating Officer and Secretary

 

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