LOS ANGELES--(BUSINESS WIRE)--Glancy Prongay & Murray LLP (“GPM”) announces that it has filed a class action lawsuit in the United States District Court for the Southern District of New York, captioned Caramihai v. Helius Medical Technologies, Inc. et al. (Case No. 1:19-cv-06365), on behalf of persons and entities that purchased or otherwise acquired Helius Medical Technologies, Inc. (NASDAQ: HSDT) (“Helius” or the “Company”) securities between November 9, 2017 and April 10, 2019, inclusive (the “Class Period”). Plaintiff pursues claims under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 (the “Exchange Act”).
Investors are hereby notified that they have 60 days from the date of this notice to move the Court to serve as lead plaintiff in this action.
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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.
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If you purchased Helius securities during the Class Period, you may move the Court no later than 60 days from the date of this notice to ask the Court to appoint you as lead plaintiff. To be a member of the Class you need not take any action at this time; you may retain counsel of your choice or take no action and remain an absent member of the Class. If you wish to learn more about this action, or if you have any questions concerning this announcement or your rights or interests with respect to these matters, please contact Lesley Portnoy, Esquire, of GPM, 1925 Century Park East, Suite 2100, Los Angeles, California 90067 at 310-201-9150, Toll-Free at 888-773-9224, by email to email@example.com, or visit our website at www.glancylaw.com. If you inquire by email please include your mailing address, telephone number and number of shares purchased.
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