Problems grow for neuromodulation firm Helius Medical Technologies

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

“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: 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.”