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NEW YORK, NY / ACCESSWIRE / August 13, 2019 / Pomerantz LLP announces that a class action lawsuit has been filed against Helius Medical Technologies, Inc. (“Helius” or the “Company”) (HSDT) and certain of its officers. The class action, filed in United States District Court, for the Southern District of New York, and indexed under 19-cv-07171, is on behalf of a class consisting of all persons and entities other than Defendants who purchased or otherwise Helius securities between November 9, 2017, and April 10, 2019, inclusive (the “Class Period”), seeking to pursue remedies under the Securities Exchange Act of 1934 (the “Exchange Act”).
If you are a shareholder who purchased Helius securities during the class period, you have until September 9, 2019, to ask the Court to appoint you as Lead Plaintiff for the class. A copy of the Complaint can be obtained at www.pomerantzlaw.com. To discuss this action, contact Robert S. Willoughby at rswilloughby@pomlaw.com or 888.476.6529 (or 888.4-POMLAW), toll-free, Ext. 9980. Those who inquire by e-mail are encouraged to include their mailing address, telephone number, and the number of shares purchased.
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Helius Medical Technologies, Inc., a neurotechnology company, focuses on developing, licensing, or acquiring noninvasive technologies for the treatment of symptoms caused by neurological disease or trauma. The company's product is Portable Neuromodulation Stimulator (“PoNS”), a medical device for the treatment of chronic balance deficit associated with a mild to moderate traumatic brain injury. Its PoNS device treats neurostimulation of cranial nerves via the tongue to restore lost function.
The Complaint alleges that throughout the Class Period, the 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 defendants failed to disclose to investors that: (i) the clinical study on the use of PoNS did not produce statistically significant results regarding the effectiveness of the treatment; (ii) as a result, the clinical study did not support the Company’s application for regulatory clearance; (iii) as a result, the Company was unlikely to receive regulatory approval of PoNS; and (iv) as a result of the foregoing, Defendants’ positive statements about the Company’s business, operations, and prospects were materially false and/or misleading and/or lacked a reasonable basis.
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 PoNS.