June 30, 2020 - The case was was voluntarily dismissed.
July 9, 2019 - An investor in shares of Helius Medical Technologies, Inc. (NASDAQ: HSDT) filed a lawsuit in the U.S. District Court for the Southern District of New York over alleged violations of Federal Securities Laws by Helius Medical Technologies, Inc. in connection with certain allegedly false and misleading statements made between November 9, 2017 and April 10, 2019.
Newtown, PA based Helius Medical Technologies, Inc., a medical technology company, focuses on the development of products for the treatment of neurological symptoms caused by disease or trauma.
On January 22, 2019, an article was published stating that Helius Medical Technologies’ phase III trial “missed its primary effectiveness endpoint” and that Helius “has redacted important trial info.” The article further states that the founders “have a history of questionable marketing practices” and that the former CEO “is now a fugitive.”
On April 10, 2019, Helius Medical Technologies’ 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
Shares of Helius Medical Technologies, Inc. (NASDAQ: HSDT) declined from $17.97 per share in October 2017 to as low as $1.77 per share on April 11, 2019.
According to the complaint the plaintiff alleges on behalf of purchasers of Helius Medical Technologies, Inc. (NASDAQ: HSDT) common shares between November 9, 2017 and April 10, 2019, that the defendants violated Federal Securities Laws. More specifically, the plaintiff claims that between November 9, 2017 and April 10, 2019, the 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.