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“Dr. Napoli and his team are important contributors to our PTAP program, and we are elated about their participation in the TEP study. NCNE is a highly reputable medical center known for its high-touch, integrated approach to treating MS and other neurological conditions. The center's unique approach to patient care will further enhance our understanding of the impact of PoNS therapy, as applied in real-world clinical settings, on therapeutic outcome,” said
“It’s been well established that many people suffering the physical symptoms of MS are able to manage their disease progression with advanced pharmacological and non-pharmacological therapeutic interventions. PoNS therapy has shown the ability to improve gait and balance in patients with MS, and we are thrilled to include this important treatment in our broad spectrum of high-quality neurological care,” stated
About
About the Therapeutic Experience Program
The Therapeutic Experience Program is a Helius-sponsored, open label observational, interventional multi-center outcome research trial designed to assess adherence to on-label PoNS therapy for improvement in gait deficits for patients with MS in a real-world clinical setting. The study will rate subjects’ adherence to PoNS therapy, which combines the PoNS device with physical therapy, to better understand the relationship between adherence to the treatment regimen and therapeutic functional outcome. The primary endpoint of the study is maintenance of gait improvement from the end of supervised therapy (Phase 1) to the end of unsupervised therapy (Phase 2) in relation to the subject’s adherence to PoNS therapy. The secondary endpoint is improvement of gait and balance deficit over time and clinical global impression of change.
The study will be conducted at ten to twelve Centers of Excellence across
About
About the PoNS Device and PoNS Therapy
The Portable Neuromodulation Stimulator is an innovative non-surgical medical device, inclusive of a controller and mouthpiece, which delivers electrical stimulation to the surface of the tongue to improve balance and gait. The PoNS device is indicated for use in
PoNS is also authorized for sale in
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
There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those expressed or implied by such statements. Important factors that could cause actual results to differ materially from the Company’s expectations include uncertainties associated with the Company’s capital requirements to achieve its business objectives, the impact of the COVID-19 pandemic, the Company’s ability to train physical therapists in the supervision of the use of the PoNS Treatment, the Company’s ability to secure contracts with rehabilitation clinics, the Company’s ability to obtain national Medicare coverage and to obtain a reimbursement code so that the PoNS device is covered by Medicare and Medicaid, the Company’s ability to build internal commercial infrastructure, secure state distribution licenses, build a commercial team and build relationships with Key Opinion Leaders, neurology experts and neurorehabilitation centers, market awareness of the PoNS device, future clinical trials and the clinical development process, manufacturing and supply chain risks, the product development process and FDA regulatory submission review and approval process, other development activities, ongoing government regulation, and other risks detailed from time to time in the “Risk Factors” section of the Company’s Annual Report on Form 10-K for the year ended
The reader is cautioned not to place undue reliance on any forward-looking statement. 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.
Investor Relations Contact
T: 212-452-2793
E: lwilson@insitecony.com
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