“NEW YORK, Feb. 7, 2019 /PRNewswire/ — Kaplan Fox & Kilsheimer LLP has been investigating claims on behalf of investors of Helius Medical Technologiues, Inc. (“Helius” or the “Company”) (Nasdaq: HSDT).
On January 22, 2019, after the market opened, White Diamond Research published an article on Seeking Alpha titled “Helius Medical: A Failed Clinic Trial, Redacted Data, And Questionable Leadership, Points To An Ineffective Device.” The article states that Helius “is a pre-revenue, $200M+ market cap company claiming its only product, the Portable Neuromodulation Stimulator (PoNS) device, can treat a type of brain injury by functional electrical stimulation of the tongue.”
The article by White Diamond Research:
- “Helius Medical is a reverse-merger, single-product, pre-revenue medical device company with a unique device that delivers stimulation to the tongue to treat a type of brain injury.
- Evidence suggests the device is likely a placebo, and positive patient results were from the intense physical therapy treatment, not the device.
- The founders, which include Montel Williams and the former CEO who is now a fugitive, have a history of questionable marketing practices.
- The phase III trial missed its primary effectiveness endpoint, thus reducing the chances of FDA approval and reimbursement coverage.
- The fact that Helius has redacted important trial info should cause investors concern about the potential effectiveness of the device.”
On the FDA’s request for more information re. PoNS device:
“NEWTOWN, Pa., Jan. 25, 2019 (GLOBE NEWSWIRE) — Helius Medical Technologies, Inc. (Nasdaq:HSDT) (TSX:HSM) (“Helius” or the “Company”), a neurotech company focused on neurological wellness, today announced that it has received a request for an additional information (“AI”) letter 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 the Portable Neuromodulation Stimulator (PoNS™) device
During the substantive review phase of a request for De Novo classification and 510(k) clearance, FDA may request additional information in order to obtain information necessary for the agency to continue or complete its review and, in such instances, places its review on hold until the requested information is submitted.
“We have enjoyed a good relationship with FDA in the development and review of our file. We believe we have the data and information to address FDA’s questions and we look forward to submitting our response to enable FDA to resume its review process as expeditiously as possible,” said Philippe Deschamps, Helius’ Chief Executive Officer. “We will continue to work towards securing clearance of PoNS.”