According to the Complaint, Helius is a neurotechnology company that purports to develop, license, or acquire non-invasive technologies targeted at reducing symptoms of neurological disease or trauma. The Company’s Portable Neuromodulation Stimulator (“PoNS”) is purportedly 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/or misleading statements, as well as failed to disclose material adverse facts about the Company’s business, operations, and prospects. Specifically, the Complaint alleges 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.
On December 3, 2019, the Court issued an Order consolidating cases. On April 28, 2020, the Court issued an Order appointing Lead Plaintiff and Counsel. This case was voluntarily dismissed on July 1.