Helius Medical Technologies, Inc.

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.

The complaint filed in this class action alleges that throughout the Class Period, 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.