Helius Medical Technologies, Inc.
- Company Name
- Helius Medical Technologies, Inc.
- Stock Symbol
- Class Period
- November 9, 2017 to April 10, 2019
- Motion Deadline
- September 7, 2019
- Southern District of New York
The complaint charges Helius and certain of its officers with violations of the Securities Exchange Act of 1934. Helius is a neurotechnology company that develops, licenses and acquires non-invasive technologies targeted at reducing symptoms of neurological disease or trauma. The Company’s Portable Neuromodulation Stimulator (PoNS™) device is a medical device for the treatment of chronic balance deficit associated with mild to moderate traumatic brain injury.
The complaint alleges that throughout the Class Period, defendants made materially false and misleading statements and/or failed to disclose adverse facts about the Company’s business, operations, and prospects. Specifically, contrary to defendants’ representations during the Class Period, the clinical study on the PoNS device had not produced “statistically significant improvements in balance” and, thus, would not support the Company’s application for regulatory approval from the U.S. Food and Drug Administration (the “FDA”). As a consequence, while the Company was announcing during the Class Period that it was “laying the groundwork for the commercial launch of [the] PoNS [device] following FDA clearance,” the Company was unlikely to receive that clearance. As a result of this information being withheld from the market, Helius securities traded at artificially inflated prices during the Class Period, with its stock price reaching a high of more than $14 per share.
On January 25, 2019, the Company announced it had received a request for additional data and information from the FDA related to the Company’s request for de novo classification and 510(k) clearance of its PoNS device. On this news, the price of Helius stock fell $0.48 per share, or nearly 6%, to close at $7.13 per share on January 25, 2019. Then, on April 10, 2019, Helius announced that the FDA had 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, the price of Helius stock fell $4.11 per share, or more than 66%, to close at $2.10 per share on April 10, 2019.