Helius Announces Positive Outcome of the Portable Neuromodulation Stimulator PoNS® Stroke Registrational Program and Upcoming Submission to FDA Under Breakthrough Designation
Helius Medical Technologies (NASDAQ: HSDT) has announced positive results from its PoNS (Portable Neuromodulation Stimulator) Stroke Registrational Program (SRP), supporting an upcoming FDA submission for treating gait and balance deficits in chronic stroke patients.
The program included three clinical trials with 159 total patients across 10 clinical sites in the US and Canada. The double-blind randomized trial successfully met its primary endpoint, demonstrating statistically significant improvements in gait/balance deficits with active PoNS therapy. The studies showed minimal adverse events and good treatment tolerability.
The company plans to submit an FDA application in Q3 2025 under its current Breakthrough Device Designation, targeting a market of over 7 million stroke patients, of which approximately 80% experience balance and gait deficits.
Helius Medical Technologies (NASDAQ: HSDT) ha annunciato risultati positivi dal suo Programma di Registrazione PoNS (Portable Neuromodulation Stimulator) per l'ictus, a supporto di una prossima domanda alla FDA per il trattamento dei deficit di deambulazione e equilibrio nei pazienti con ictus cronico.
Il programma ha incluso tre studi clinici con un totale di 159 pazienti in 10 centri clinici negli Stati Uniti e in Canada. Lo studio randomizzato in doppio cieco ha raggiunto con successo l'endpoint primario, dimostrando miglioramenti statisticamente significativi nei deficit di deambulazione ed equilibrio con la terapia PoNS attiva. Gli studi hanno riportato eventi avversi minimi e una buona tollerabilità del trattamento.
L'azienda prevede di presentare una domanda alla FDA nel terzo trimestre del 2025, sotto la sua attuale Designazione di Dispositivo Innovativo, puntando a un mercato di oltre 7 milioni di pazienti colpiti da ictus, di cui circa l'80% presenta deficit di equilibrio e deambulazione.
Helius Medical Technologies (NASDAQ: HSDT) ha anunciado resultados positivos de su Programa de Registro PoNS (Portable Neuromodulation Stimulator) para accidentes cerebrovasculares, apoyando una próxima solicitud a la FDA para tratar déficits de marcha y equilibrio en pacientes con accidente cerebrovascular crónico.
El programa incluyó tres ensayos clínicos con un total de 159 pacientes en 10 sitios clínicos en EE. UU. y Canadá. El ensayo aleatorizado doble ciego cumplió con éxito su objetivo principal, demostrando mejoras estadísticamente significativas en déficits de marcha y equilibrio con la terapia activa PoNS. Los estudios mostraron eventos adversos mínimos y buena tolerancia al tratamiento.
La compañía planea presentar una solicitud a la FDA en el tercer trimestre de 2025 bajo su actual Designación de Dispositivo Innovador, apuntando a un mercado de más de 7 millones de pacientes con accidente cerebrovascular, de los cuales aproximadamente el 80 % presentan déficits de equilibrio y marcha.
Helius Medical Technologies (NASDAQ: HSDT)는 만성 뇌졸중 환자의 보행 및 균형 장애 치료를 위한 FDA 제출을 지원하는 PoNS(휴대용 신경조절 자극기) 뇌졸중 등록 프로그램(SRP)의 긍정적인 결과를 발표했습니다.
이 프로그램은 미국과 캐나다의 10개 임상 사이트에서 총 159명의 환자를 대상으로 한 3건의 임상 시험을 포함했습니다. 이중맹검 무작위 시험은 주요 평가 변수를 성공적으로 달성했으며, 활성 PoNS 치료를 통해 보행 및 균형 장애가 통계적으로 유의미하게 개선됨을 보여주었습니다. 연구에서는 부작용이 최소화되었고 치료 내약성이 우수했습니다.
회사는 현재 혁신 의료기기 지정(Breakthrough Device Designation) 하에 2025년 3분기에 FDA 신청을 계획하고 있으며, 약 80%가 균형 및 보행 장애를 겪는 700만 명 이상의 뇌졸중 환자 시장을 목표로 하고 있습니다.
Helius Medical Technologies (NASDAQ : HSDT) a annoncé des résultats positifs issus de son programme d’enregistrement PoNS (Portable Neuromodulation Stimulator) pour l’AVC, soutenant une prochaine soumission à la FDA visant à traiter les déficits de marche et d’équilibre chez les patients victimes d’un AVC chronique.
Le programme comprenait trois essais cliniques regroupant au total 159 patients dans 10 centres cliniques aux États-Unis et au Canada. L’essai randomisé en double aveugle a atteint son critère principal, démontrant des améliorations statistiquement significatives des déficits de marche et d’équilibre avec la thérapie active PoNS. Les études ont montré des effets indésirables minimes et une bonne tolérance au traitement.
L’entreprise prévoit de soumettre une demande à la FDA au troisième trimestre 2025 dans le cadre de sa désignation actuelle de dispositif révolutionnaire, ciblant un marché de plus de 7 millions de patients victimes d’un AVC, dont environ 80 % présentent des déficits d’équilibre et de marche.
Helius Medical Technologies (NASDAQ: HSDT) hat positive Ergebnisse aus seinem PoNS (Portable Neuromodulation Stimulator) Schlaganfall-Registrierungsprogramm (SRP) bekannt gegeben, die eine bevorstehende FDA-Einreichung zur Behandlung von Geh- und Gleichgewichtsstörungen bei chronischen Schlaganfallpatienten unterstützen.
Das Programm umfasste drei klinische Studien mit insgesamt 159 Patienten an 10 klinischen Standorten in den USA und Kanada. Die doppelblinde randomisierte Studie erreichte erfolgreich ihren primären Endpunkt und zeigte statistisch signifikante Verbesserungen der Geh- und Gleichgewichtsstörungen durch die aktive PoNS-Therapie. Die Studien berichteten über minimale Nebenwirkungen und eine gute Verträglichkeit der Behandlung.
Das Unternehmen plant, im dritten Quartal 2025 einen FDA-Antrag im Rahmen seiner aktuellen Breakthrough Device Designation einzureichen und zielt auf einen Markt von über 7 Millionen Schlaganfallpatienten ab, von denen etwa 80 % an Gleichgewichts- und Gehproblemen leiden.
- Clinical trials successfully met primary endpoint showing statistically significant improvements in stroke patients
- Minimal adverse events and good treatment tolerability demonstrated in studies
- Large addressable market of 7 million stroke patients, with 80% having balance/gait deficit
- FDA Breakthrough Device Designation status already secured for stroke indication
- PoNS device not yet FDA approved for stroke rehabilitation
- FDA submission and approval process still pending with uncertain outcome
Insights
Helius' PoNS device achieved positive clinical results for stroke rehabilitation, advancing toward FDA submission under Breakthrough Designation.
Helius Medical's announcement represents a significant regulatory milestone for their Portable Neuromodulation Stimulator (PoNS) device. The company has successfully completed their Stroke Registrational Program (SRP) with positive primary outcome data that will support their upcoming FDA submission. The double-blind randomized trial met its primary endpoint, demonstrating statistically significant improvements in gait and balance for chronic stroke patients using active PoNS therapy.
What makes this particularly notable is the device's current Breakthrough Device Designation from FDA for stroke applications. This designation expedites the review process for technologies addressing serious conditions with substantial advantages over existing alternatives. The successful completion of their clinical program puts Helius on track for a Q3 2025 submission.
The company's clinical program was comprehensive, including 159 patients across three studies (a double-blind RCT, a single-arm trial, and an investigator-initiated RCT) conducted at 10 clinical sites in the US and Canada. The 130 patients who completed the full 24-week study period (12 weeks treatment plus 12 weeks follow-up) showed not only efficacy but also minimal adverse events and good tolerability.
The regulatory strategy appears sound - Helius engaged with FDA before initiating the program in March 2024 to align on study design and endpoints. The positive outcomes position the company well for their upcoming submission, though FDA authorization is never guaranteed even with Breakthrough status.
From a clinical perspective, these PoNS results address a critical unmet need in stroke rehabilitation. Approximately 80% of the 7 million stroke patients experience balance and gait deficits, significantly impacting mobility, independence, and fall risk. Current rehabilitation options for chronic stroke patients (those beyond the initial recovery phase) often yield limited improvements.
The PoNS device represents a novel neuromodulation approach combined with physical therapy. What's particularly meaningful in the data is the demonstration of statistically significant improvements in both primary endpoints (gait/balance) and the secondary endpoints examining fall risk and durability of effect 12 weeks post-treatment. This suggests the therapy produces lasting neuroplastic changes rather than temporary improvements.
The study design merits attention - all three trials used consistent patient populations, treatment protocols, and endpoints, strengthening the validity of the findings. The physical therapy component followed current rehabilitation guidelines, meaning the device provided benefits beyond standard care. Additionally, the safety profile showing minimal adverse events and good tolerability is crucial for a chronic-use neuromodulation device.
If approved, this would represent one of the first device-based neuromodulation approaches specifically authorized for chronic stroke rehabilitation. For patients with persistent deficits who have plateaued with conventional therapy, this non-invasive approach could potentially restart recovery processes through targeted neuroplasticity stimulation, addressing the substantial disability burden of post-stroke gait and balance impairments.
NEWTOWN, Pa., July 21, 2025 (GLOBE NEWSWIRE) -- Helius Medical Technologies, Inc. (NASDAQ: HSDT), a neurotech company focused on delivering a novel therapeutic neuromodulation approach for balance and gait deficits, today announced positive outcome from the PoNS (Portable Neuromodulation Stimulator) Stroke Registrational Program (SRP) supporting a planned FDA submission seeking an indication for gait and balance deficit in patients with chronic symptoms of stroke under the current Breakthrough Device Designation.
The key primary outcomes from the SRP indicate that:
- A double-blind randomized clinical trial met the primary endpoint of demonstrating statistically significant greater improvements in gait and/or balance deficit due to stroke with active PoNS therapy with and without including additional data from an open label study using statistical methods to balance baseline characteristics.
- The studies also confirmed a minimal incidence of adverse events and good treatment tolerability.
“The successful execution of the PoNS SRP and the positive results of the clinical trials mark an important milestone in advancing the standard of care for stroke and offer individuals suffering from gait/balance disability a meaningful therapeutic option to rehabilitate and regain their functionality,” stated Antonella Favit-Van Pelt, M.D., Ph.D., Helius’ Chief Medical Officer. “We look forward to releasing the SRP’s study results this quarter and to continuing working closely with FDA under the upcoming application for authorization of the Agency’s breakthrough designated PoNS device.”
Helius started the SRP in March 2024 after a positive interaction with the FDA on the data development program, study design, and endpoints. The SRP includes two pivotal Sponsor-initiated clinical studies: a double-blind, randomized controlled trial and a single-arm trial, which began in April 2024. The SRP is also supported by a pilot investigator-initiated, double-blind randomized controlled trial by Dr. Steve Kautz and Dr. Mark Bowden of MUSC (SC) and Brook Rehabilitation (FL) respectively, which began late in the fall of 2023. All three clinical trials enrolled patients from the same patient population and shared the same study structure/endpoints aimed at establishing the efficacy and safety of PoNS in people with gait deficit due to chronic stroke.
A total of 159 patients were enrolled across the three studies, with 130 patients completing both the 12-week study treatment phase and the 12-week post treatment follow-up period, at 10 clinical sites including centers of excellence for stroke rehabilitation across the US and Canada. Study participants received the (active or sham) study treatment in combination with physical therapy according to the current guidelines for functional rehabilitation of people with chronic stroke.
The primary endpoints for all three studies included improvement of gait and/or balance deficit after 12 weeks of study treatment with two key multiplicity-controlled secondary endpoints assessing risk of falling and 12-week durability of effect. The double-blind randomized clinical trial met the primary endpoint of demonstrating statistically significant greater improvements in gait and/or balance deficit due to stroke with active PoNS Therapy with and without including additional data from an open label study using statistical methods to balance baseline characteristics. The studies also demonstrated minimal incidence of adverse events and confirmed good treatment tolerability.
“More than 7 million patients suffer from the symptoms of stroke and about
The PoNS has not yet been approved in the United States for use in stroke rehabilitation and remains investigational for this use. Helius is planning to file a submission to the FDA for an indication in stroke during the third quarter of 2025 under its current FDA breakthrough designation for stroke.
About the PoNS Device and PoNS Therapy
The Portable Neuromodulation Stimulator (“PoNS”) is an innovative, non-implantable, orally applied therapy that delivers neurostimulation through a mouthpiece connected to a controller and it’s used, primarily at home, with physical rehabilitation exercise, to improve balance and gait. The PoNS device, which delivers mild electrical impulses to the tongue, is indicated for use in the United States as a short-term treatment of gait deficit due to mild-to-moderate symptoms from MS and is to be used as an adjunct to a supervised therapeutic exercise program in patients 22 years of age and over by prescription only.
PoNS has shown effectiveness in treating gait or balance and a significant reduction in the risk of falling in stroke patients in Canada, where it received authorization for sale in three indications: (i) for use as a short-term treatment (14 weeks) of gait deficit due to mild and moderate symptoms from stroke and is to be used in conjunction with physical therapy; (ii) for use as a short-term treatment (14 weeks) of chronic balance deficit due to mild-to-moderate traumatic brain injury (“mmTBI”) and is to be used in conjunction with physical therapy; and (iii) for use as a short-term treatment (14 weeks) of gait deficit due to mild and moderate symptoms from MS and is to be used in conjunction with physical therapy. PoNS is also authorized for sale in Australia for short term use by healthcare professionals as an adjunct to a therapeutic exercise program to improve balance and gait. For more information visit www.ponstherapy.com.
About Helius Medical Technologies, Inc.
Helius Medical Technologies is a leading neurotech company in the medical device field focused on neurologic deficits using orally applied technology platform that amplifies the brain’s ability to engage physiologic compensatory mechanisms and promote neuroplasticity, improving the lives of people dealing with neurologic diseases. The Company’s first commercial product is the Portable Neuromodulation Stimulator. For more information about the PoNS or Helius Medical Technologies, visit www.heliusmedical.com.
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. Forward-looking statements are often identified by terms such as “believe,” “expect,” “continue,” “will,” “goal,” “aim” and similar expressions. Such forward-looking statements include, among others, statements regarding future presentation and uses of the PoNSTEP study results, the availability of commercial reimbursement and the uses and effectiveness of PoNS and PoNS Therapy.
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, availability of funds, the Company’s ability to find additional sources of funding, manufacturing, labor shortage and supply chain risks, including risks related to manufacturing delays, the Company’s ability to obtain national Medicare insurance coverage and to obtain a reimbursement code, the Company’s ability to continue to build internal commercial infrastructure, secure state distribution licenses, market awareness of the PoNS device, future clinical trials and the clinical development process, the product development process and the 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 December 31, 2023, and its other filings with the United States Securities and Exchange Commission and the Canadian securities regulators, which can be obtained from either at www.sec.gov or www.sedar.com.
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
Philip Trip Taylor
Gilmartin Group
investorrelations@heliusmedical.com
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