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.