Helius Medical Technologies, Inc. Announces Second Partnership to Implement Clinical Experience Programs with PoNS™ Treatment in the United States
NEWTOWN, Pa., Oct. 24, 2018 (GLOBE NEWSWIRE) -- Helius Medical Technologies, Inc. (NASDAQ:HSDT) (TSX:HSM) (“Helius” or the “Company”), a neurotech company focused on neurological wellness, today announced that its wholly owned subsidiary, NeuroHabilitation Corporation, has partnered with Northwell Health’s Feinstein Institute for Medical Research in Manhasset, NY. This partnership will enable Helius to implement its second Clinical Experience Program (CEP) for its Portable Neuromodulation Stimulator (PoNS™) -- an investigational medical device in the US currently under review for market clearance by the US Food & Drug Administration. PoNS is a licensed class II medical device in Canada.
The CEP will be performed at three of Northwell Health’s clinical sites including North Shore University Hospital (NSUH) and Transitions of Long Island in Manhasset, NY and Southside Hospital in Bay Shore, NY.
CEPs are sponsored by Helius and implemented in partnership with leading neurorehabilitation centers, including academic and research institutions, hospital systems and high-volume independent neurorehabilitation centers. CEPs enable Helius to thoroughly investigate in the clinical setting, the PoNS treatment in patients suffering from chronic balance deficit due to mild- to moderate-traumatic brain injury (TBI).
“We are delighted to partner with NeuroHabilitation Corporation, as we look to further treatment options for our patients who suffer from TBI,” said Jamie Ullman, MD, Director of Neurotrauma at North Shore University Hospital and principal investigator of the Feinstein Institute study. “PoNS treatment is a promising new technology which may enhance recovery after TBI by integrating tongue stimulation with specialized physical therapy.”
“Helius is pleased to announce this important partnership with the Feinstein Institute for Medical Research,” said Philippe Deschamps, Helius’ Chief Executive Officer. “Following our recently announced CEP partnerships with Ohio State University Wexner Medical Center, our partnership with the Feinstein Institute will enable us to implement our second CEP, which we are pursuing as part of our pre-regulatory clearance activities for the investigational PoNS device.”
Mr. Deschamps continued: “By implementing CEPs, we aim to generate real-world clinical evidence and valuable health outcomes data, while building relationships with leading neurorehabilitation centers and key opinion leaders in the area of TBI. We look forward to working with Dr. Ullman and the staff at all of the participating Northwell Health clinical sites included in this CEP partnership to begin recruiting and enrolling patients for the PoNS Treatment in the fourth quarter of 2018.”
About Helius Medical Technologies, Inc.
Helius Medical Technologies is a neurotech company focused on neurological wellness. The Company’s purpose is to develop, license and acquire unique and non-invasive platform technologies that amplify the brain’s ability to heal itself. The Company’s first product in development is the Portable Neuromodulation Stimulator (PoNS). For more information, visit www.heliusmedical.com.
About the Feinstein Institute
The Feinstein Institute for Medical Research is the research arm of Northwell Health, the largest healthcare provider in New York. Home to 50 research laboratories and to clinical research throughout dozens of hospitals and outpatient facilities, the Feinstein Institute includes 4,000 researchers and staff who are making breakthroughs in molecular medicine, genetics, oncology, brain research, mental health, autoimmunity, and bioelectronic medicine – a new field of science that has the potential to revolutionize medicine. For more information about how we empower imagination and pioneer discovery, visit FeinsteinInstitute.org
About the PoNS Device and PoNS Treatment
The Portable Neuromodulation Stimulator (PoNS) is an investigational, non-invasive, medical device in the US currently under review by the US Food & Drug Administration for clearance to improve balance in patients following a mild-to-moderate traumatic brain injury (mTBI) when combined with targeted physical therapy. PoNS is currently not commercially available in the US. PoNS is a licensed class II medical device in Canada.
PoNS Treatment is the first and only tongue-delivered neuromodulation that combines stimulation of cranial nerves with physical and cognitive therapy to restore lost neurological function. The Company’s trials investigating the PoNS in traumatic brain injury are more fully discussed in the Company’s disclosure materials, including its Annual Report on Form 10-K and other filings with the United States Securities and Exchange Commission.
Cautionary Disclaimer Statement:
All statements other than statements of historical fact included in this news release are forward-looking statements that involve risks and uncertainties. Such forward-looking statements include, among others, the expected timing of the company’s planned pre-submission meeting with FDA and the expected timing of the Company’s submission regulatory approval of the PoNS device.
Forward-looking statements are often identified by terms such as “believe”, “will”, “may”, “should”, “anticipate”, “expects”, “estimate”, “intend” and similar expressions.
There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those anticipated in such statements. Important factors that could cause actual results to differ materially from the Company’s expectations include the uncertainties associated with the FDA regulatory submission and approval process, including the possibility that the FDA may not find the Company’s regulatory submission sufficient to support clearance, the process of negotiating with rehabilitation centers to implement CEPs, the uncertainty of the health outcomes data to be generated by the CEPs, uncertainties associated with commercial contracting process, the Company’s need to raise additional capital to achieve its business objectives and other risks detailed from time to time in the filings made by the Company with securities regulators.
The reader is cautioned that assumptions used in the preparation of any forward-looking statements may prove to be incorrect. Events or circumstances may cause actual results to differ materially from those predicted, as a result of numerous known and unknown risks, uncertainties, and other factors, many of which are beyond the control of the Company. The reader is cautioned not to place undue reliance on any forward-looking statement. Such information, although considered reasonable by management at the time of preparation, may prove to be incorrect and actual results may differ materially from those anticipated. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement. Risks and uncertainties about the Company’s business are more fully discussed in the Company’s disclosure materials, including its Annual Report on Form 10-K for the year ended December 31, 2017, its Quarterly Reports on Form 10-Q for the quarters ended March 31, 2018 and June 30, 2018 and its other filings with the United States Securities and Exchange Commission and the Canadian securities regulators and which can be obtained from either at www.sec.gov or www.sedar.com.
The forward-looking statements contained in this news release are made as of the date of this news release and the Company assumes no obligation to update any forward-looking statement or to update the reasons why actual results could differ from such statements except to the extent required by law.
The Toronto Stock Exchange has not reviewed and does not accept responsibility for the adequacy or accuracy of the content of this news release.
Investor Relations Contact:
Westwicke Partners on behalf of Helius Medical Technologies, Inc.
Mike Piccinino, CFA