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Problems grow for neuromodulation firm Helius Medical Technologies

Investor Alert: Kaplan Fox Inves­ti­gates Helius Med­ical Tech­nolo­gies, Inc. (press release):

NEW YORKFeb. 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: A Failed Clin­i­cal Tri­al, Redact­ed Data, And Ques­tion­able Lead­er­ship, Points To An Inef­fec­tive Device (Seek­ing Alpha):

Arti­cle sum­ma­ry:

  • 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:

Helius Med­ical Tech­nolo­gies, Inc. Pro­vides Update on FDA’s Review of its Request for De Novo Clas­si­fi­ca­tion and 510(k) Clear­ance of the PoNS™ Device (com­pa­ny press release):

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.”

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As seen in The New York Times, The Wall Street Journal, BBC News, CNN, Reuters,  SharpBrains is an independent market research firm tracking how brain science can improve our health and our lives.

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