Helius Medical Technologies, Inc. Announces Reimbursement by Major Healthcare Provider for its Portable Neuromodulation Stimulator (PoNS®) Device
Helius Medical Technologies (NASDAQ: HSDT) has secured reimbursement approval from United Healthcare for its Portable Neuromodulation Stimulator (PoNS®) Device, making it the second major healthcare provider after Anthem to offer coverage. The approved reimbursement amount totals $18,100, which includes patient co-payment and represents the adjusted list price for out-of-network status.
The PoNS Device is designed to improve balance and gait deficits while reducing fall risk. This development marks a significant milestone in Helius's strategy to expand patient access through commercial payor coverage and third-party reimbursement, particularly benefiting MS patients.
Helius Medical Technologies (NASDAQ: HSDT) ha ottenuto l'approvazione per il rimborso da parte di United Healthcare per il suo dispositivo Portable Neuromodulation Stimulator (PoNS®), diventando il secondo importante fornitore di assistenza sanitaria, dopo Anthem, a offrire copertura. L'importo approvato per il rimborso è di 18.100 $, che include la quota a carico del paziente e rappresenta il prezzo di listino adeguato per lo status fuori rete.
Il dispositivo PoNS è progettato per migliorare i deficit di equilibrio e deambulazione, riducendo il rischio di cadute. Questo sviluppo rappresenta una tappa significativa nella strategia di Helius di ampliare l'accesso dei pazienti attraverso la copertura commerciale e il rimborso da parte di terzi, con particolare beneficio per i pazienti affetti da sclerosi multipla.
Helius Medical Technologies (NASDAQ: HSDT) ha asegurado la aprobación de reembolso por parte de United Healthcare para su dispositivo Portable Neuromodulation Stimulator (PoNS®), convirtiéndose en el segundo proveedor importante de atención médica, después de Anthem, en ofrecer cobertura. El monto aprobado para el reembolso es de 18,100 $, que incluye el copago del paciente y representa el precio ajustado para el estatus fuera de red.
El dispositivo PoNS está diseñado para mejorar los déficits de equilibrio y marcha, reduciendo el riesgo de caídas. Este avance representa un hito importante en la estrategia de Helius para ampliar el acceso de los pacientes mediante la cobertura comercial y el reembolso de terceros, beneficiando especialmente a los pacientes con esclerosis múltiple.
Helius Medical Technologies (NASDAQ: HSDT)가 United Healthcare로부터 휴대용 신경조절 자극기(PoNS®) 장치에 대한 보험 환급 승인을 받았으며, Anthem에 이어 두 번째 주요 의료 제공자가 보험 적용을 제공하게 되었습니다. 승인된 환급 금액은 18,100달러로, 환자의 본인부담금을 포함하며 네트워크 외 상태에 대한 조정된 가격입니다.
PoNS 장치는 균형 및 보행 장애를 개선하고 낙상 위험을 줄이도록 설계되었습니다. 이번 성과는 Helius가 상업 보험 적용 및 제3자 환급을 통해 환자 접근성을 확대하려는 전략에서 중요한 이정표로, 특히 다발성 경화증 환자에게 큰 혜택을 줍니다.
Helius Medical Technologies (NASDAQ : HSDT) a obtenu l'approbation du remboursement de la part de United Healthcare pour son dispositif Portable Neuromodulation Stimulator (PoNS®), devenant ainsi le deuxième grand fournisseur de soins de santé, après Anthem, à offrir une couverture. Le montant approuvé pour le remboursement s'élève à 18 100 $, incluant la participation du patient et représentant le prix catalogue ajusté pour le statut hors réseau.
Le dispositif PoNS est conçu pour améliorer les déficits d'équilibre et de démarche tout en réduisant le risque de chute. Cette avancée marque une étape importante dans la stratégie de Helius visant à élargir l'accès des patients grâce à la couverture commerciale et au remboursement tiers, bénéficiant particulièrement aux patients atteints de sclérose en plaques.
Helius Medical Technologies (NASDAQ: HSDT) hat von United Healthcare die Erstattungsgenehmigung für sein Portable Neuromodulation Stimulator (PoNS®) Gerät erhalten und ist damit nach Anthem der zweite große Gesundheitsdienstleister, der eine Kostenübernahme anbietet. Der genehmigte Erstattungsbetrag beläuft sich auf 18.100 $, einschließlich der Zuzahlung des Patienten und entspricht dem angepassten Listenpreis für den Status außerhalb des Netzwerks.
Das PoNS-Gerät ist darauf ausgelegt, Gleichgewichts- und Gangdefizite zu verbessern und das Sturzrisiko zu verringern. Diese Entwicklung stellt einen bedeutenden Meilenstein in der Strategie von Helius dar, den Patientenzugang durch kommerzielle Kostenträger und Drittanbieter-Erstattungen zu erweitern, was insbesondere MS-Patienten zugutekommt.
- Second major healthcare provider (United Healthcare) approves PoNS Device reimbursement
- Significant reimbursement amount of $18,100 approved, reflecting full adjusted list price
- Validation of clinical need and device value through pricing approval
- Expanded market access potential for MS patients
- Coverage is currently at out-of-network status, not in-network
- Limited to only two major healthcare providers so far
United Healthcare approves claim for PoNS Device at out-of-network adjusted list price, becoming the second payer to join Anthem in providing PoNS reimbursement
NEWTOWN, Pa., May 12, 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 improving balance and gait deficits and reducing the risk of falling, today announced a reimbursement approval for the PoNS Device from a second major healthcare provider, United Healthcare.
“This additional claim approval and reimbursement from a second major healthcare provider at typical out of network adjusted price further validates the clinical need and benefits of PoNS and reinforces the true value of the device. We believe this pricing should support further constructive conversations with payors,” said Dane Andreeff, Helius President and Chief Executive Officer. “We continue to pursue commercial payor coverage and broad third-party reimbursement as part of our growth strategy to increase patient access to PoNS. We are pleased with this progress in our efforts to support more MS patients.”
The total lump sum approved reimbursement amount, including patient co-payment, was
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 (PoNS®). For more information about PoNS or Helius Medical Technologies, visit www.heliusmedical.com.
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 while 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.
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 potential to expand commercial payor coverage and broad third-party reimbursement as part of the Company’s growth strategy to increase patient access to PoNS.
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, market conditions and availability of funds from third parties to finance Revelation Neuro, Inc., 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 adequate 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, 2024, 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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