We are investigating Helius Medical Technologies, Inc. (HSDT) (“Helius” or the “Company”) for potential violations of the federal securities laws.
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. On this news, Helius’s stock price fell sharply during intraday trading on April 10, 2019, damaging investors.