Helius Medical Technologies, Inc. Announces First Clinical Evidence of Positive Long-term Therapeutic Effects of PoNS Therapy® on Gait Deficit Improvement in Multiple Sclerosis from the PoNS® Therapeutic Experience Program Study
Helius Medical Technologies (NASDAQ:HSDT) has announced positive results from their PoNS Therapeutic Experience Program (PoNSTEP) study for multiple sclerosis (MS) patients. The study demonstrated significant long-term benefits of PoNS Therapy on gait deficit improvement.
The study involved 43 MS patients who underwent 14 weeks of physical rehabilitation with PoNS Therapy, including 2 weeks in clinic (Phase 1) and 12 weeks at home (Phase 2), followed by a 6-month observation period (Phase 3). Of 41 patients who started, 38 completed the study.
Key findings include a statistically significant total mean improvement of 5.00 points in Dynamic Gait Index (DGI) at week 14. Phase 2 showed 71% therapy adherence with a linear association between adherence and improvement. Notably, participants with ≥85% adherence improved by mean 3.7 points compared to 2.0 points for those with lower adherence. At 6-months post-treatment, only 1 of 28 reassessed participants showed ≥30% decline in DGI.
Helius Medical Technologies (NASDAQ:HSDT) ha annunciato risultati positivi dal loro programma PoNS Therapeutic Experience Program (PoNSTEP) per pazienti affetti da sclerosi multipla (SM). Lo studio ha dimostrato benefici significativi a lungo termine della terapia PoNS sul miglioramento del deficit di deambulazione.
Lo studio ha coinvolto 43 pazienti con SM, che hanno seguito 14 settimane di riabilitazione fisica con terapia PoNS, comprese 2 settimane in clinica (Fase 1) e 12 settimane a casa (Fase 2), seguite da un periodo di osservazione di 6 mesi (Fase 3). Dei 41 pazienti che sono partiti, 38 hanno completato lo studio.
I risultati chiave includono un miglioramento medio totale statisticamente significativo di 5,00 punti nell'Indice di Deambulazione Dinamico (DGI) alla settimana 14. La Fase 2 ha mostrato un'adesione al trattamento del 71% con un'associazione lineare tra aderenza e miglioramento. È interessante notare che i partecipanti con un'aderenza ≥85% hanno migliorato in media di 3,7 punti rispetto a 2,0 punti per quelli con un'aderenza inferiore. A 6 mesi post-trattamento, solo 1 dei 28 partecipanti rivalutati ha mostrato un declino ≥30% nel DGI.
Helius Medical Technologies (NASDAQ:HSDT) ha anunciado resultados positivos de su programa PoNS Therapeutic Experience Program (PoNSTEP) para pacientes con esclerosis múltiple (EM). El estudio demostró beneficios significativos a largo plazo de la terapia PoNS en la mejora del déficit de marcha.
El estudio involucró a 43 pacientes con EM que sometieron a 14 semanas de rehabilitación física con terapia PoNS, incluyendo 2 semanas en clínica (Fase 1) y 12 semanas en casa (Fase 2), seguidas de un periodo de observación de 6 meses (Fase 3). De los 41 pacientes que comenzaron, 38 completaron el estudio.
Los hallazgos clave incluyen una mejora media total estadísticamente significativa de 5,00 puntos en el Índice de Marcha Dinámico (DGI) a las 14 semanas. La Fase 2 mostró una adherencia a la terapia del 71% con una asociación lineal entre la adherencia y la mejora. Notablemente, los participantes con ≥85% de adherencia mejoraron en promedio 3,7 puntos en comparación con 2,0 puntos para aquellos con menor adherencia. A los 6 meses tras el tratamiento, solo 1 de los 28 participantes re-evaluados mostró una disminución ≥30% en DGI.
헬리우스 메디컬 테크놀로지스 (NASDAQ:HSDT)는 다발성 경화증(MS) 환자를 위한 PoNS 치료 경험 프로그램(PoNSTEP) 연구에서 긍정적인 결과를 발표했습니다. 이 연구는 PoNS 치료가 보행 결손 개선에 미치는 장기적인 유익을 입증했습니다.
이 연구에는 43명의 MS 환자가 참여했으며, 이들은 14주 동안 PoNS 치료를 통한 물리 치료를 받았습니다. 여기에는 클리닉에서 2주(1단계)와 집에서 12주(2단계)가 포함되었고, 이후 6개월 관찰 기간(3단계)이 이어졌습니다. 시작한 41명 중 38명이 연구를 완료했습니다.
주요 결과로는 14주차에 동적 보행 지수(DGI)에서 평균 5.00점의 통계적으로 유의미한 개선이 포함됩니다. 2단계는 치료 이행율 71%를 보여주었으며, 이행률과 개선 간에 선형적인 관계가 있음을 나타냈습니다. 특히, 이행률이 ≥85%인 참여자는 평균 3.7점 개선된 반면, 이행률이 낮은 참여자는 2.0점 개선되었습니다. 치료 후 6개월이 지나 재평가된 28명 중 오직 1명만이 DGI에서 ≥30% 감소를 보였습니다.
Helius Medical Technologies (NASDAQ:HSDT) a annoncé des résultats positifs de son programme PoNS Therapeutic Experience Program (PoNSTEP) pour les patients atteints de sclérose en plaques (SEP). L'étude a démontré des avantages significatifs à long terme de la thérapie PoNS sur l'amélioration des déficits de la marche.
L'étude a impliqué 43 patients atteints de SEP qui ont suivi 14 semaines de réhabilitation physique avec la thérapie PoNS, dont 2 semaines en clinique (Phase 1) et 12 semaines à domicile (Phase 2), suivies d'une période d'observation de 6 mois (Phase 3). Parmi les 41 patients qui ont commencé, 38 ont terminé l'étude.
Les résultats clés incluent une amélioration moyenne totale statistiquement significative de 5,00 points sur l'Indice de Marche Dynamique (DGI) à la semaine 14. La Phase 2 a montré une adherence à la thérapie de 71% avec une association linéaire entre l'adhérence et l'amélioration. Il est intéressant de noter que les participants avec une adhérence ≥85% ont amélioré en moyenne de 3,7 points par rapport à 2,0 points pour ceux avec une adhérence plus faible. Six mois après le traitement, seul 1 des 28 participants réévalués a montré une diminution ≥30% du DGI.
Helius Medical Technologies (NASDAQ:HSDT) hat positive Ergebnisse aus ihrem PoNS Therapeutic Experience Program (PoNSTEP) für Patienten mit Multipler Sklerose (MS) bekannt gegeben. Die Studie hat signifikante langfristige Vorteile der PoNS-Therapie bei der Verbesserung von Gangdefiziten aufgezeigt.
In der Studie waren 43 MS-Patienten beteiligt, die 14 Wochen körperlicher Rehabilitation mit PoNS-Therapie unterzogen wurden, einschließlich 2 Wochen in der Klinik (Phase 1) und 12 Wochen zu Hause (Phase 2), gefolgt von einer 6-monatigen Beobachtungsphase (Phase 3). Von den 41 Patienten, die teilnahmen, schlossen 38 die Studie ab.
Wesentliche Ergebnisse umfassen eine statistisch signifikante Gesamtmittelverbesserung von 5,00 Punkten im Dynamic Gait Index (DGI) nach 14 Wochen. Phase 2 zeigte eine Therapietreue von 71% mit einer linearen Assoziation zwischen Treue und Verbesserung. Besonders bemerkenswert war, dass Teilnehmer mit ≥85% Treue im Durchschnitt um 3,7 Punkte besser abschnitten, verglichen mit 2,0 Punkten für Teilnehmer mit niedrigerer Treue. Sechs Monate nach der Behandlung zeigte nur 1 von 28 erneut bewerteten Teilnehmern einen Rückgang von ≥30% im DGI.
- Statistically significant improvement in Dynamic Gait Index (DGI) with total mean improvement of 5.00 points
- High therapy completion rate with 38 out of 41 patients finishing the study
- Strong durability of treatment effects with only 1 out of 28 patients showing significant decline after 6 months
- Clear correlation between higher adherence (≥85%) and better outcomes (3.7 points vs 2.0 points improvement)
- Treatment adherence dropped from 89.5% in Phase 1 to 71% in Phase 2
- Mean decline of -4.1% in DGI observed during follow-up period
Insights
The latest clinical evidence from Helius Medical Technologies represents a significant breakthrough in MS treatment. The PoNS Therapy study revealed compelling data that could reshape treatment approaches for Multiple Sclerosis patients struggling with mobility issues.
Breaking down the key findings in simple terms:
- The therapy showed a strong success rate, with 38 out of 41 patients completing the full treatment protocol
- Patients achieved meaningful improvements in their walking ability, measured by a standardized test called the Dynamic Gait Index (DGI)
- The improvements were maintained for 6 months after treatment, with 27 out of 28 patients retaining their gains
What makes these results particularly compelling is the durability of the treatment effect. In the MS treatment landscape, where maintaining improvements is often challenging, the 6-month sustainability of results is remarkable. The study also revealed a direct correlation between treatment adherence and outcomes - patients who followed the protocol more closely (>85% adherence) showed nearly twice the improvement compared to those with lower adherence.
From a medical perspective, these results validate the role of neuroplasticity in treating MS mobility issues. The therapy's ability to enhance the brain's natural adaptation mechanisms through targeted neuromodulation represents a novel approach that could complement existing MS treatments.
For investors, this data strengthens Helius's position in the neuromodulation market. The demonstrated efficacy and durability of results could drive broader adoption among healthcare providers and potentially lead to expanded insurance coverage. The clear correlation between adherence and outcomes also suggests opportunities for developing complementary monitoring and compliance tools.
--PoNS Therapeutic Experience Program (PoNSTEP) study demonstrates durable long-term beneficial effects of PoNS Therapy on gait deficit improvement in people with Multiple Sclerosis--
--Statistically significant findings in DGI (Dynamic Gait Index) during Phase 1 and Phase 2 among the 38 subjects who completed the treatment protocol showing a total mean improvement of 5.00 (4.1 to 5.9, p<0.001) at week 14--
NEWTOWN, Pa., Jan. 22, 2025 (GLOBE NEWSWIRE) -- Helius Medical Technologies, Inc. (Nasdaq:HSDT) (“Helius” or the “Company”), a neurotech company focused on delivering a novel therapeutic neuromodulation approach for balance and gait deficits, today announced positive results from the PoNS Therapeutic Experience Program, or PoNSTEP, study for people with multiple sclerosis (MS).
“The results from this study validate existing evidence of the efficacy of PoNS across clinical data and real-world utilization of the therapy by demonstrating durability of effect as further evidence of its long-term therapeutic benefits,” stated Antonella Favit-Van Pelt, M.D., Ph.D., Helius’ Chief Medical Officer. “The PoNSTEP study marks an important stepstone in further understanding the role of neuromodulation and, consequently, neuroplasticity in gait function rehabilitation. PoNS Therapy’s neuromodulation effect on brain mechanisms of motor control is likely to enhance neuroplasticity and contribute to maintain PoNS therapeutic effect on gait deficit in people with MS.”
The recently completed study, provides the first clinical evidence of a positive relationship between adherence to using the PoNS device with targeted physical exercise (PoNS Therapy) and improvement of gait deficit, along with establishing the long-term therapeutic effect of PoNS Therapy at six months post-treatment in people with MS. This observation is in line with maintenance of effect’s evidence from other clinical trials in people with balance deficits due to traumatic brain injury.
The study involved 43 patients with gait deficit due to mild-to-moderate MS, who received 14 weeks of physical rehabilitation with PoNS Therapy. The therapy included 2 weeks in the clinic (Phase 1) and 12 weeks at home (Phase 2), followed by a 6-month post-treatment observation (Phase 3). Of the 41 patients who started, 38 completed the study, and 29 were evaluated at 6 months. Patients with a
PoNSTEP Results
- There were statistically significant findings in DGI during Phase 1 and Phase 2 among the 38 subjects who completed the treatment protocol for a total mean improvement of 5.00 (4.1 to 5.9, p<0.001) at week 14.
- In Phase 2, average therapy adherence
71% and gait improvement was linearly associated with adherence (r=0.345; p=0.034), while, in Phase 1 adherence, was89.5% and, consequently, not associated with improvement. - In addition to mean 2.5 points improvement in DGI achieved in Phase 1, Phase 2, participants with ≥
85% adherence improved mean 3.7 points [1.8 SD]; those with <85% adherence improved mean 2.0 points [1.8 SD], and the difference was statistically significant [p=.0.008]. - 28 of 41 (
70.7% ) participants who completed the 14-wk therapy were reassessed at 6-months and only 1 of 28 showed ≥30% decline in DGI (95% exact binomial CI:0.09% to18.4% ). - Mean decline (%) in DGI was -4.1 (
95% CI -9.4% to1.1% ; range -35.7% to25.0% ) with the95% CI’s lower bound showing statistically reliable evidence that the true mean decline was no more than -9.4% (p=0.12).
“We are pleased to report the PoNSTEP study results corroborate the known evidence of PoNS Therapy’s efficacy in improving gait deficit due to MS,” stated Dane Andreeff, Helius’ President and Chief Executive Officer. “Like many therapeutics, treatment compliance is key to achieving incremental and lasting therapeutic beneficial effects with PoNS Therapy. This important study provides convincing evidence of the role of neuroplasticity for a durable gait function improvement in MS. We thank all the investigators and patients involved in the study and we look forward to sharing the data to increase awareness on PoNS Therapy at upcoming scientific conferences.”
About PoNS Therapeutic Experience Program (PoNSTEP)
The Therapeutic Experience Program (“TEP”) is a Helius-sponsored, open label observational, interventional multi-center outcome research study designed to assess adherence to on-label PoNS therapy for improvement in gait deficits for patients with multiple sclerosis (“MS”) in a real-world clinical setting. The study aims to understand better the relationship between adherence to on label (100-120 minute per day) PoNS Therapy, which combines the PoNS device with physical therapy, and the therapeutic outcome on gait deficit improvement over 14 weeks of study treatment, as measured by changes in the Dynamic Gait Index (DGI) scores. PoNS therapy is applied in a supervised clinical setting for the first two weeks (Phase 1) and, independently, at home for the remaining 12 weeks (Phase 2). The study also includes a six month no-treatment follow-up phase aimed at establishing durability of therapeutic effect (Phase 3).
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 endpoints are, among others, maintenance of improvement of gait and balance deficit over 6-m timeframe and clinical global impression of change.
The study was performed at six Centers of Excellence across the United States, including Neurology Center of New England in Foxboro (MA), the Shepherd Center in Atlanta (GE), Montefiore Medical Center (“Montefiore”) in NY (NY), Oregon Health & Science University (“OHSU”) in Portland (OR), MGH Institute of Health Professions in Boston (MA), NYU Langone Health in NY (NY), and recruited 43 MS participants with gait deficit.
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 multiple sclerosis (“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 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
FAQ
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