Helius Announces FDA 510(k) Submission for PoNS® Device Label Expansion in Stroke
Helius Medical Technologies (NASDAQ: HSDT) has submitted a 510(k) application to the FDA for its PoNS (Portable Neuromodulation Stimulator) device, seeking label expansion for treating gait and balance deficit in chronic stroke patients. The submission, filed under FDA Breakthrough Device Designation, is supported by the Stroke Registrational Program (SRP) data.
The clinical trials, involving 159 chronic stroke survivors across 10 sites, demonstrated that PoNS Therapy combined with physical therapy achieved a clinically meaningful improvement of over 5 points in the Functional Gait Assessment (FGA), compared to less than 4 points in the control group. The treatment effect was maintained for at least 12 weeks post-therapy, with 89.7% of subjects meeting durability goals. The device proved safe with no treatment-related serious adverse events.
Helius Medical Technologies (NASDAQ: HSDT) ha presentato una domanda 510(k) alla FDA per il PoNS (Stimolatore Neuromodulatore Portatile), chiedendo l’espansione dell’etichetta per trattare deficit di cammino ed equilibrio in pazienti con ictus cronico. La submission, presentata nell’ambito della Breakthrough Device Designation della FDA, è supportata dai dati del Stroke Registrational Program (SRP).
Gli studi clinici, che hanno coinvolto 159 sopravvissuti a ictus cronico in 10 centri, hanno dimostrato che PoNS Therapy in combinazione con fisioterapia ha raggiunto un miglioramento clinicamente significativo di oltre 5 punti nel Functional Gait Assessment (FGA), rispetto a meno di 4 punti nel gruppo di controllo. L’effetto del trattamento è rimasto stabile per almeno 12 settimane dopo la terapia, con l’89,7% dei soggetti che ha raggiunto gli obiettivi di durabilità. Il dispositivo si è rivelato sicuro, senza eventi avversi gravi correlati al trattamento.
Helius Medical Technologies (NASDAQ: HSDT) ha presentado una solicitud 510(k) ante la FDA para su dispositivo PoNS (Estimulación Neuromoduladora Portátil), buscando ampliar la etiqueta para tratar déficits de marcha y equilibrio en pacientes con ictus crónico. La presentación, realizada bajo la Designación de Dispositivo Innovador (Breakthrough Device) de la FDA, cuenta con el apoyo de los datos del Stroke Registrational Program (SRP).
Los ensayos clínicos, que involucraron a 159 supervivientes de ictus crónico en 10 centros, demostraron que la PoNS Therapy combinada con fisioterapia alcanzó una mejora clínicamente significativa de más de 5 puntos en la Functional Gait Assessment (FGA), en comparación con menos de 4 puntos en el grupo de control. El efecto del tratamiento se mantuvo durante al menos 12 semanas tras la terapia, con el 89,7% de los sujetos cumpliendo los objetivos de durabilidad. El dispositivo demostró seguridad, sin eventos adversos graves relacionados con el tratamiento.
헬리우스 메디컬 테크놀로지스(NASDAQ: HSDT)는 PoNS(휴대형 신경조절 자극기) 장치에 대해 FDA에 510(k) 신청서를 제출하여 만성 뇌졸중 환자의 보행 및 균형 결손 치료를 위한 라벨 확장을 모색하고 있습니다. 이 제출은 FDA의 Breakthrough Device Designation(혁신 디바이스 지정) 하에 제출되었으며, Stroke Registrational Program(SRP) 데이터를 뒷받침합니다.
10개 기관에서 만성 뇌졸중 생존자 159명을 대상으로 한 임상시험은 PoNS 치료를 물리치료와 병행했을 때 보행 기능 평가(FGA)에서 임상적으로 의미 있는 5점 이상 개선을 달성했고, 대조군에서는 4점 미만이었습니다. 치료 효과는 치료 후 최소 12주간 유지되었으며, 피험자의 89.7%가 내구성 목표를 달성했습니다. 장치는 치료 관련 중대한 이상반응 없이 안전한 것으로 증명되었습니다.
Helius Medical Technologies (NASDAQ: HSDT) a déposé une demande 510(k) auprès de la FDA pour son appareil PoNS (Stimulation Neuromodulatrice Portative), en vue d’étendre l’étiquette pour traiter les déficits de marche et d’équilibre chez les patients ayant subi un AVC chronique. La soumission, effectuée dans le cadre de la désignation Breakthrough Device de la FDA, est soutenue par les données du Stroke Registrational Program (SRP).
Les essais cliniques, impliquant 159 survivants d’AVC chronique dans 10 sites, ont démontré que la thérapie PoNS associée à la physiothérapie a atteint une amélioration cliniquement significative de plus de 5 points sur l’évaluation fonctionnelle de la marche (FGA), par rapport à moins de 4 points dans le groupe témoin. L’effet du traitement a été maintenu pendant au moins 12 semaines après la thérapie, avec 89,7% des sujets atteignant les objectifs de durabilité. Le dispositif s’est avéré sûr, sans événements indésirables graves liés au traitement.
Helius Medical Technologies (NASDAQ: HSDT) hat einen 510(k)-Antrag bei der FDA für sein PoNS-Gerät (Portable Neuromodulation Stimulator) eingereicht, um die Kennzeichnung zur Behandlung von Geh- und Gleichgewichtsstörungen bei chronischen Schlaganfallpatienten zu erweitern. Die Einreichung, die im Rahmen der Breakthrough Device Designation der FDA erfolgt, wird durch die Daten des Stroke Registrational Program (SRP) unterstützt.
Die klinischen Studien mit 159 chronischen Schlaganfallüberlebenden an 10 Standorten zeigten, dass PoNS-Therapie in Kombination mit Physiotherapie eine klinisch signifikante Verbesserung von über 5 Punkten im Functional Gait Assessment (FGA) erzielte, verglichen mit weniger als 4 Punkten in der Kontrollgruppe. Der Behandlungseffekt blieb mindestens 12 Wochen nach der Therapie bestehen, wobei 89,7% der Probanden die Haltbarkeitsziele erreichten. Das Gerät erwies sich als sicher, ohne behandlungsbedingte schwerwiegende unerwünschte Ereignisse.
هيليوس ميديكال تكنولوجيز (الرمز في ناسداك: HSDT) قد قدمت طلب 510(k) إلى إدارة الغذاء والدواء الأمريكية لجهاز PoNS (المحفز العصبي الكهربائي المحمول)، ساعية لتوسيع الملصق ليشمل علاج عجز المشي والتوازن لدى مرضى السكتة الدماغية المزمنة. وتقديم الطلب، المقدم بموجب تصنيف الجهاز الثوري Breakthrough Device Designation من FDA، مدعوم ببيانات برنامج تسجيل السكتة الدماغية (SRP).
شملت التجارب السريرية< b>159 ناجياً من السكتة الدماغية المزمنة عبر 10 مراكز، وأظهرت أن PoNS Therapy المصاحبة للعلاج الطبيعي حققت تحسناً ذو دلالة سريرية يتجاوز 5 نقاط في تقييم المشي الوظيفي (FGA)، مقارنة بأقل من 4 نقاط في مجموعة التحكم. ظل أثر العلاج ثابتاً لمدة لا تقل عن 12 أسبوعاً بعد العلاج، مع تحقيق 89.7% من المشاركين لأهداف الثبات. كما ثبت أن الجهاز آمن، دون حدوث أحداث سلبية خطيرة مرتبطة بالعلاج.
希利厄斯医疗科技公司（纳斯达克股票代码：HSDT）已向FDA提交510(k)申请，针对PoNS（便携式神经调制刺激器）设备，寻求将标签扩展至治疗慢性中风患者的步态和平衡缺陷。该申请在FDA突破性设备指定（Breakthrough Device Designation）框架下提交，并得到中风登记项目（SRP）数据的支持。
临床试验涉及< b>来自10个站点的159名慢性中风幸存者，结果显示PoNS治疗结合物理治疗在功能步态评估（FGA）上实现了< b>超过5分的临床显著改善，对比对照组不足4分。治疗效果在治疗结束后至少维持12周，89.7%的受试者达到耐久性目标。该设备被证明安全，未出现与治疗相关的严重不良事件。
- None.
- Berg Balance Score improvements did not reach statistical significance
- Risk of falling reduction was not statistically significant between groups
Insights
Helius' FDA submission for PoNS stroke indication shows promising efficacy data, potentially expanding market reach for this breakthrough device.
Helius Medical's 510(k) submission for their PoNS device represents a significant regulatory milestone with substantial market implications. The submission seeks to expand the device's indications to include gait and balance deficits in chronic stroke patients, building upon their existing Breakthrough Device Designation. The clinical data package appears robust, comprising three trials across 10 sites with 159 enrolled patients.
The primary endpoint results are particularly compelling. Patients using active PoNS Therapy with physical therapy achieved a mean Functional Gait Assessment (FGA) improvement of more than 5 points, exceeding the clinically meaningful threshold of 4.2 points. This was statistically significant (p<0.05) and durable, with benefits maintained for at least 12 weeks post-treatment. In contrast, the control group saw less than 4-point improvements, falling below clinical significance thresholds.
The detailed statistical analysis using propensity score methodology showed an adjusted mean FGA change of 5.37 points in the treatment group versus 3.31 points in controls, with the difference meeting statistical significance requirements (p=0.0233). Importantly, 89.7% of subjects maintained durability of effect at follow-up. While secondary endpoints for balance (Berg Balance Score) and fall risk showed improvements, they didn't reach statistical significance between groups.
The safety profile remains excellent with no treatment-related serious adverse events and minimal device-related adverse events (0-14.8%), consistent with previous real-world evidence. This submission leverages their Breakthrough Device Designation, which could potentially expedite regulatory review timeframes and enhance reimbursement prospects upon approval.
Helius' stroke indication submission could significantly expand PoNS market potential with 795,000 annual stroke cases in the US alone.
This FDA submission represents a major potential market expansion for Helius Medical's PoNS device. Stroke rehabilitation represents an enormous untapped market opportunity - substantially larger than their current indications. Chronic stroke patients with persistent gait and balance issues often plateau with conventional therapies, creating significant unmet need for novel interventions.
The data presented in this submission demonstrates compelling clinical utility, showing not just statistical significance but meaningful functional improvements that could translate to enhanced patient independence and quality of life. The durability of effect is particularly notable, as it suggests potential long-term benefits beyond the active treatment period.
The Breakthrough Device Designation carries substantial commercial advantages beyond just expedited review. Under CMS rules, breakthrough devices can potentially qualify for streamlined Medicare coverage determinations, which would dramatically simplify reimbursement pathways. Private insurers often follow Medicare's lead, potentially creating a favorable coverage environment upon approval.
The submission timing aligns well with increasing healthcare system focus on rehabilitation outcomes and value-based care. Devices that can demonstrate functional improvements with durable effects are increasingly prioritized by payers seeking to reduce long-term care costs and readmissions.
If approved, this expanded indication would allow Helius to target stroke rehabilitation centers and neurological practices nationwide, significantly expanding their addressable market. The non-invasive nature and apparent safety profile of PoNS further enhances its commercial potential, as it could potentially be administered in outpatient settings without specialized surgical facilities.
Seeking an indication for gait and balance deficit in patients with chronic symptoms of stroke under its Breakthrough Device Designation
NEWTOWN, Pa., Sept. 25, 2025 (GLOBE NEWSWIRE) -- Helius Medical Technologies, Inc. (NASDAQ: HSDT), today announced the filing of its U.S. Food and Drug Administration (FDA) 510(k) submission for the PoNS (Portable Neuromodulation Stimulator) device label expansion seeking an indication for gait and balance deficit in patients with chronic stroke symptoms. The submission was made with data generated in its Stroke Registrational Program (SRP) and was filed under its current FDA Breakthrough Device Designation.
All statistical analyses for the Functional Gait Assessment (FGA) primary endpoint demonstrated PoNS superior effectiveness in improving gait deficit by achieving a clinically meaningful mean improvement of more than 5 points, which was statistically significant across all studies (p<0.05) and was maintained for at least 12 weeks after completion of the therapy. Conversely the control group achieved, across all trials, a mean FGA improvement of less than 4 points, which fell below the 4.2-point Minimal Detectable Change (MDC) that reflects clinical meaningfulness of the therapeutic intervention.
“Substantial evidence across the SRP trials supports the superiority of active PoNS Therapy® as compared to physical therapy alone, when applied in standard clinical settings for stroke rehabilitation,” said Antonella Favit-Van Pelt, M.D., Ph.D., Helius’ Chief Medical Officer. “The totality of data in stroke survivors with gait deficits confirms the broader evidence of PoNS therapeutic effect in improving walking disability by enhancing and potentiating the benefit of physical therapy. Consistent with the existing body of clinical evidence, PoNS also confirms to be a safe and well tolerated therapy.”
PoNS efficacy and safety was clinically established from three clinical trials across 10 sites and 159 enrolled chronic stroke survivors with gait deficit due to stroke. The studies were structured to assess the effectiveness and safety of the PoNS device in conjunction with routine physical rehabilitation therapy over a 12-week treatment period. Participants were also followed for 12 weeks after completion of treatment to assess durability of treatment effect. Primary efficacy endpoints for gait (by FGA) and balance (by the Berg Balance Score), as well as key secondary endpoints including risk of falling (determined by FGA <23) and durability of effect (established at <
Overall, the primary endpoint was met and statistically significant for the FGA primary endpoint. In the primary analysis of the pooled pivotal randomized controlled and single-arm studies, treatment with active PoNS plus physical therapy (PT) led to an adjusted mean change in FGA of 5.37 points (
"Submitting our 510(k) application to the FDA brings the benefits on gait from PoNS Therapy one step closer to stroke patients," said Dane Andreeff, CEO of Helius. "I'm incredibly proud of our team and thankful to the clinicians who facilitated this trial as we work together to increase patient access to this powerful therapy. We’re optimistic about a positive FDA outcome and the opportunity to support those living with the effects of 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.
The Company has adopted a digital asset treasury strategy focused on accumulating SOL, the native digital asset of the Solana blockchain, leveraging capital markets raises that produce consistent on-chain yield generation. Helius will provide access to the Solana network.
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 SRP study results, successful outcome of the FDA submission, 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
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