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Helius Announces First Partnership to Implement Clinical Experience Programs With the Investigational PoNS™ Therapy in the United States
NEWTOWN, Pa., Sept. 19, 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 it has partnered with The Ohio State University Wexner Medical Center, a leading U.S. neurorehabilitation center located in Columbus, OH to establish the Company’s first Clinical Experience Program for the Company’s Portable Neuromodulation Stimulator (PoNS™), an investigational medical device.
Helius’ Clinical Experience Programs (“CEPs”) are being sponsored by the Company to be implemented in partnership with leading, early-adopter, neurorehabilitation centers in the United States, including academic and research institutions, hospital systems and high-volume independent neurorehabilitation centers. CEPs will allow the Company to offer an open label clinical study of PoNS therapy in patients suffering from chronic balance deficit due to mild- to moderate-traumatic brain injury (“TBI”).
“We expect our Clinical Experience Programs will be an important component of the Company’s pre-regulatory clearance activities because they will enable us to build relationships with leading, early-adopter, neurorehabilitation centers and key opinion leaders in the area of TBI, generate clinical evidence and gain real-world experience in the use of our PoNS device,” said Philippe Deschamps, Helius’ Chief Executive Officer. “Our Clinical Experience Programs are open label clinical studies that enable us to treat patients in a real-world clinical setting in advance of a 510(k) clearance for our PoNS device from the U.S. Food and Drug Administration.”
Mr. Deschamps continued: “After we contract with a neurorehabilitation center to implement a new CEP, we will obtain institutional review board approval, train the CEP site’s physical therapists and then begin patient recruitment. We believe these CEPs will allow us to validate our proposed commercial model for use of the PoNS in the clinical setting after we receive 510(k) clearance. Importantly, Helius’ CEPs will generate health outcomes data which we intend to use to support the value proposition of use of the PoNS device in coverage discussions with payers. Looking ahead, we expect to begin patient recruitment and enrollment at The Ohio State University Wexner Medical Center during the fourth quarter of 2018 and we look forward to announcing additional CEP partnerships later this year.”
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 PoNS Device and PoNS Treatment
The Portable Neuromodulation Stimulator (PoNS) is an investigational, non-invasive, medical device.
PoNS Treatment is being developed as 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.
About The Ohio State University Wexner Medical Center
One of the nation's leading academic medical centers, The Ohio State University Wexner Medical Center offers healthcare services in virtually every specialty and subspecialty in medicine. Thousands of patients come to us each month for treatments and services they cannot find anywhere else. Providing access to healthcare information is core to our research, education and patient care mission. At Ohio State Wexner Medical Center, we're dedicated to improving health in Ohio and across the world through innovation in research, education and patient care.
Cautionary Disclaimer Statement:
Certain statements in this news release are not based on historical facts and constitute forward-looking statements or forward-looking information within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and Canadian securities laws.
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, statements regarding the potential clearance by the FDA of the Company’s 510(k) regulatory submission, the future commercial launch of the PoNS device, the entry into of additional CEPs, the ability of CEPs to validate the Company’s commercial model and provide for the potential acceleration of the Company’s commercial contracting process.
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 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 neurorehabilitation 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 Report on Form 10-Q for the quarter ended 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