NEW YORK, July 12, 2019 (GLOBE NEWSWIRE) -- Bronstein, Gewirtz & Grossman, LLC notifies investors that a class action lawsuit has been filed against Helius Medical Technologies, Inc. (“Helius” or the “Company”) (NASDAQ: HSDT) and certain of its officers, on behalf of shareholders who purchased or otherwise acquired Helius securities from November 9, 2017 and April 10, 2019, inclusive (the “Class Period”). Such investors are encouraged to join this case by visiting the firm’s site:  www.bgandg.com/hsdt.

This class action seeks to recover damages against Defendants for alleged violations of the federal securities laws under the Securities Exchange Act of 1934.

On January 25, 2019, Helius said that it had received a request for additional data and information from the U.S. Food and Drug Administration (the “FDA”) related to the its request for de novo classification and 510(k) clearance of its Portable Neuromodulation Stimulator (PoNS™) device. Following this news, Helius stock dropped $0.48 per share, or roughly 6%, to close at $7.13 on January 25, 2019.

On April 10, 2019, Helius disclosed that the U.S. Food and Drug Administration (“FDA”) had declined the Company’s request for De Novo classification and clearance of its Portable Neuromodulation Stimulator device.  The FDA stated that it lacked sufficient data to determine the relative contributions of the device and physical therapy in clinical studies.  Following this news, Helius stock dropped $4.11 per share, or more than 66%, to close at $2.10 on April 10, 2019.

The complaint alleges that throughout the Class Period, defendants made false and/or misleading statements and/or failed to disclose that:  (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.

If you wish to review a copy of the Complaint you can visit the firm’s site: www.bgandg.com/hsdt or you may contact Peretz Bronstein, Esq. or his Investor Relations Analyst, Yael Hurwitz of Bronstein, Gewirtz & Grossman, LLC at 212-697-6484. If you suffered a loss in Helius you have until September 9, 2019 to request that the Court appoint you as lead plaintiff.  A lead plaintiff acts on behalf of all other class members in directing the litigation. The lead plaintiff can select a law firm of its choice. Your ability to share in any recovery doesn't require that you serve as a lead plaintiff.

Bronstein, Gewirtz & Grossman, LLC is a corporate litigation boutique.  Our primary expertise is the aggressive pursuit of litigation claims on behalf of our clients.  In addition to representing institutions and other investor plaintiffs in class action security litigation, the firm’s expertise includes general corporate and commercial litigation, as well as securities arbitration.   Attorney advertising. Prior results do not guarantee similar outcomes.

Contact:
Bronstein, Gewirtz & Grossman, LLC
Peretz Bronstein or Yael Hurwitz
212-697-6484 | info@bgandg.com