BENSALEM, Pa.–(BUSINESS WIRE)–$HSDT #classaction–Law Offices of Howard G. Smith announces that a class action lawsuit has been filed on behalf of investors who purchased Helius Medical Technologies, Inc. (“Helius” or the “Company”) (NASDAQ: HSDT) securities between November 9, 2017 and April 10, 2019, inclusive (the “Class Period”). Helius investors have until September 9, 2019 to file a lead plaintiff motion.
Investors suffering losses on their Helius investments are encouraged to contact the Law Offices of Howard G. Smith to discuss their legal rights in this class action at 888-638-4847 or by email to [email protected].
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.
If you purchased shares of Helius, have information, would like to learn more about these claims, or have any questions concerning this announcement or your rights or interests with respect to these matters, please contact Howard G. Smith, Esquire, of Law Offices of Howard G. Smith, 3070 Bristol Pike, Suite 112, Bensalem, Pennsylvania 19020 by telephone at (215) 638-4847, toll-free at (888) 638-4847, or by email to [email protected], or visit our website at www.howardsmithlaw.com.
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