NEW YORK, July 10, 2019 (GLOBE NEWSWIRE) -- Gainey McKenna & Egleston announces that a class action lawsuit has been filed against Helius Medical Technologies, Inc. (“Helius” or the “Company”) (Nasdaq: HSDT) in the United States District Court for the Southern District of New York on behalf of those who purchased or acquired the securities of Helius between November 9, 2017 and April 10, 2019, inclusive (the “Class Period”), seeking to recover damages caused by Defendants’ violations of the federal securities laws and to pursue remedies under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 (the “Exchange Act”) and Rule 10b-5 promulgated thereunder.

The Complaint alleges that Defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the Company’s business, operations, and prospects. Specifically, Defendants failed to disclose to investors: (1) that the clinical study on the use of PoNS did not produce statistically significant results regarding the effectiveness of the treatment; (2) that, as a result, the clinical study did not support the Company’s application for regulatory clearance; (3) that, as a result, the Company was unlikely to receive regulatory approval of PoNS; and (4) that, as a result of the foregoing, Defendants’ positive statements about the Company’s business, operations, and prospects were materially misleading and/or lacked a reasonable basis.

On January 25, 2019, the Company announced that it had received a request for additional data and information from the U.S. Food and Drug Administration (the “FDA”) related to the Company’s request for de novo classification and 510(k) clearance of its Portable Neuromodulation Stimulator (PoNS™) device.  On this news, shares of Helius fell $0.48, or nearly 6%, to close at $7.13 per share on January 25, 2019, thereby injuring investors.

Then, on April 10, 2019, Helius announced that the FDA denied 510(k) clearance of the PoNS device because the Company had not provided sufficient clinical data to show the device was effective.  On this news, shares of Helius fell $4.11, or more than 66%, to close at $2.10 per share on April 10, 2019, thereby injuring investors further.

Investors who purchased or otherwise acquired shares during the Class Period should contact the Firm prior to the September 9, 2019 lead plaintiff motion deadline.  A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation.  If you wish to discuss your rights or interests regarding this class action, please contact Thomas J. McKenna, Esq. or Gregory M. Egleston, Esq. of Gainey McKenna & Egleston at (212) 983-1300, or via e-mail at tjmckenna@gme-law.com or gegleston@gme-law.com.

Please visit our website at http://www.gme-law.com for more information about the firm.