Helius Medical Technologies, Inc. Provides Updates on Efforts to Achieve Fair Market Access for its Portable Neuromodulation Stimulator (PoNS®) Device
Helius Medical Technologies (NASDAQ:HSDT) provided updates on reimbursement challenges for its Portable Neuromodulation Stimulator (PoNS) device. The company disagrees with CMS's proposed pricing for both the PoNS Mouthpiece and Controller, stating it reflects incomplete information and incorrect technology assessment. The pricing decisions have delayed access to PoNS Therapy for Multiple Sclerosis patients with balance and gait deficits. The company has requested a meeting with CMS before the January 1, 2025 Mouthpiece pricing implementation and is seeking to align Controller pricing implementation with the same date instead of April 1st.
Helius Medical Technologies (NASDAQ:HSDT) ha fornito aggiornamenti sulle sfide relative al rimborso per il suo dispositivo Portable Neuromodulation Stimulator (PoNS). L'azienda è in disaccordo con la proposta di prezzo di CMS per sia il bocchino PoNS che il Controller, affermando che riflette informazioni incomplete e una valutazione della tecnologia erronea. Le decisioni sui prezzi hanno ritardato l'accesso alla terapia PoNS per i pazienti affetti da sclerosi multipla con deficit di equilibrio e deambulazione. L'azienda ha richiesto un incontro con CMS prima dell'implementazione del prezzo del bocchino, prevista per il 1 gennaio 2025, e sta cercando di allineare l'implementazione del prezzo del Controller alla stessa data invece del 1 aprile.
Helius Medical Technologies (NASDAQ:HSDT) proporcionó actualizaciones sobre los desafíos de reembolso para su dispositivo Portable Neuromodulation Stimulator (PoNS). La empresa no está de acuerdo con el precio propuesto por CMS tanto para la boquilla PoNS como para el controlador, afirmando que refleja información incompleta y una evaluación errónea de la tecnología. Las decisiones de precios han retrasado el acceso a la terapia PoNS para los pacientes con esclerosis múltiple que tienen déficits de equilibrio y marcha. La empresa ha solicitado una reunión con CMS antes de la implementación del precio de la boquilla el 1 de enero de 2025 y busca alinear la implementación del precio del controlador con la misma fecha en lugar del 1 de abril.
헬리우스 의료 기술 (NASDAQ:HSDT)는 포터블 신경 조절 자극기 (PoNS) 장치의 보험 환급 문제에 대한 업데이트를 제공했습니다. 회사는 PoNS 입 모양 장치와 컨트롤러에 대한 CMS의 제안 가격에 동의하지 않으며, 이는 불완전한 정보와 잘못된 기술 평가를 반영한다고 주장합니다. 가격 결정은 균형 및 보행 결핍이 있는 다발성 경화증 환자에 대한 PoNS 치료 접근을 지연시켰습니다. 회사는 2025년 1월 1일 입 모양 장치 가격 시행 전 CMS와의 회의를 요청했으며, 컨트롤러 가격 시행을 4월 1일 대신 같은 날짜로 조정하려고 합니다.
Helius Medical Technologies (NASDAQ:HSDT) a fourni des mises à jour concernant les défis de remboursement pour son appareil Portable Neuromodulation Stimulator (PoNS). L'entreprise n'est pas d'accord avec les prix proposés par le CMS pour la pièce buccale PoNS et le contrôleur, affirmant que cela reflète des informations incomplètes et une évaluation technologique incorrecte. Les décisions tarifaires ont retardé l'accès à la thérapie PoNS pour les patients atteints de sclérose en plaques ayant des déficits d'équilibre et de marche. L'entreprise a demandé une réunion avec le CMS avant la mise en œuvre du prix de la pièce buccale le 1er janvier 2025 et cherche à aligner la mise en œuvre du prix du contrôleur avec cette même date au lieu du 1er avril.
Helius Medical Technologies (NASDAQ:HSDT) hat Aktualisierungen zu den Erstattungsherausforderungen für sein tragbares Neuromodulationsstimulationsgerät (PoNS) bereitgestellt. Das Unternehmen ist mit den von CMS vorgeschlagenen Preisen für sowohl das PoNS-Mundstück als auch den Controller nicht einverstanden und gibt an, dass diese unvollständige Informationen und eine falsche Technologieeinschätzung widerspiegeln. Die Preisentscheidungen haben den Zugang zur PoNS-Therapie für Multiple-Sklerose-Patienten mit Gleichgewichts- und Gehdefiziten verzögert. Das Unternehmen hat ein Treffen mit CMS vor der Preisumsetzung des Mundstücks am 1. Januar 2025 angefordert und strebt an, die Preisumsetzung des Controllers auf dasselbe Datum anstatt auf den 1. April auszurichten.
- VA and a private payor have successfully understood and accepted the company's pricing evidence
- CMS's unfavorable pricing determinations for both PoNS Controller and Mouthpiece
- Delayed market access affecting qualified MS patients
- Commercial launch delays due to pricing review cycles
- Company's market value negatively impacted
- Impeded ability to access public markets for financing operations
- Forced to pursue strategic alternatives due to market challenges
Insights
The CMS pricing dispute for the PoNS device represents a significant setback for Helius Medical Technologies. The agency's decision to map the Controller to a TENS device code and propose unfavorable Mouthpiece pricing creates substantial market access barriers. This pricing misalignment could severely impact the company's commercial viability, particularly given its small market cap of
The delayed implementation timeline, with the Controller pricing set for April 1st while the Mouthpiece pricing takes effect January 1st, 2025, creates operational challenges. This staggered approach disrupts the product's market entry and complicates revenue projections. The company's pursuit of strategic alternatives signals serious concerns about its financial sustainability under current circumstances.
While success with the VA and a private payer demonstrates some market potential, the Medicare market is important for widespread adoption. Without favorable CMS pricing, the company's ability to penetrate the MS patient market and achieve meaningful revenue growth is severely
Management to host business update call today at 9:00am ET
NEWTOWN, Pa., Nov. 18, 2024 (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 provided updates on its efforts to achieve fair market access for its Portable Neuromodulation Stimulator (PoNS) device and announced plans to host a business update call today at 9:00am ET.
“We disagree with the proposed pricing for the PoNS Mouthpiece and are disappointed CMS has once again mapped the Controller pricing to a code for fundamentally different technology,” said Dane Andreeff, Helius’ President and Chief Executive Officer. “In the face of this challenge our team’s response has been impressive as we continue to pursue fair market access for Medicare’s Multiple Sclerosis (MS) patients with balance and gait deficit. At the November 8th HCPCS Level 2 Public meeting we again refuted CMS’ methodology and presented compelling evidence in support of fair pricing for the PoNS device. Our diligent response and extensive evidence, outlined here today, has been successfully understood by the VA and a private payor. We are hopeful CMS can reach the same conclusions, and we will continue to support their reassessment.”
Recent Reimbursement Updates
- CMS issued pricing determinations for both the PoNS Controller and Mouthpiece that the Company believes reflect incomplete information and erroneous assessments of the technology, which currently preclude market access to PoNS device prescriptions for Medicare’s (MS) patients with balance and gait deficits
- Mouthpiece pricing to take effect January 1, 2025 does not reflect recent market pricing in the gap-filling analysis. Helius has requested a meeting with CMS to occur prior to the effective date in an attempt to correct the pricing
- Proposed Controller pricing incorrectly maps to a TENS device code as PoNS does not involve peripheral stimulation, and acts through neural plasticity and therefore is not grounded on the gate control theory of pain
- Timing for the pricing determination and reimbursement implementation of the Controller on April 1st, three months after the Mouthpiece, an accessory required for use of the device. Helius plans to request the Controller pricing to be set in tandem with the Mouthpiece on January 1st
- Enduring a third review cycle for PoNS Controller pricing and the uncertain timeline has delayed access to PoNS Therapy® for qualified MS patients and delayed Helius’ commercial launch
- Process has impacted the Company’s market value and impeded its ability to access public markets to finance its operations thus leading to the pursuit of strategic alternatives
Business Update Call
Helius management plans to host a conference call to discuss recent business updates and its efforts to achieve fair market access for the PoNS device at 9:00am ET today, November 18, 2024. Interested parties may access the live and recorded webcast here or on the “Events” page under “News & Events” on the Helius investor relations website.
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.
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.
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 CMS determinations, the Company’s future communications with CMS and the results of such communications, the potential for the Company to meet with CMS prior to the January 1 effectiveness date of the PoNS Mouthpiece pricing, the Company’s strategic alternative exploration process, and the development, commercialization and success of the Company’s PoNS and PoNS Treatment.
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, its Form 10-Q for the quarter ended September 30, 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
When will the new PoNS Mouthpiece pricing take effect for Helius Medical (HSDT)?
What is the implementation date for PoNS Controller pricing for Helius Medical (HSDT)?
Why did Helius Medical (HSDT) disagree with CMS's pricing determination?
