Helius Announces First Portable Neuromodulation Stimulator (PoNS®) System Sale to the Veterans Affairs (VA) Healthcare System
Helius Medical Technologies (NASDAQ:HSDT) announced its first PoNS System sale to the VA Healthcare System through distributor Lovell Government Services. The sale, priced at $23,844 ($16,499 for Controller, $7,345 for Mouthpiece), marks the operational implementation through VA Federal Supply Schedule Contract.
The PoNS System, indicated for treating gait deficit in adults with mild-to-moderate MS symptoms when used with physical therapy, targets a potential market of 55,000 to 70,000 veterans living with MS in the U.S. The company has sales professionals covering VA locations along the east coast and southeast, with plans to expand coverage to all VA MS Centers of Excellence network facilities.
Helius Medical Technologies (NASDAQ:HSDT) ha annunciato la sua prima vendita del sistema PoNS al VA Healthcare System attraverso il distributore Lovell Government Services. La vendita, con un prezzo di 23.844 dollari (16.499 dollari per il Controller, 7.345 dollari per il Bocchino), segna l'implementazione operativa attraverso il Contratto del VA Federal Supply Schedule.
Il sistema PoNS, indicato per il trattamento del deficit di camminata negli adulti con sintomi da SM da lievi a moderati quando usato con la terapia fisica, si rivolge a un potenziale mercato di 55.000 a 70.000 veterani che vivono con la SM negli Stati Uniti. L'azienda ha professionisti di vendita che coprono le sedi VA lungo la costa orientale e sud-est, con piani per espandere la copertura a tutte le strutture della rete VA MS Centers of Excellence.
Helius Medical Technologies (NASDAQ:HSDT) anunció su primera venta del sistema PoNS al VA Healthcare System a través del distribuidor Lovell Government Services. La venta, valorada en $23,844 ($16,499 por el Controlador, $7,345 por la Boquilla), marca la implementación operativa a través del Contrato del VA Federal Supply Schedule.
El sistema PoNS, indicado para tratar el déficit de marcha en adultos con síntomas de EM leves a moderados cuando se utiliza con fisioterapia, apunta a un mercado potencial de 55,000 a 70,000 veteranos que viven con EM en los EE. UU. La compañía cuenta con profesionales de ventas que cubren las ubicaciones de VA a lo largo de la costa este y el sureste, con planes de expandir la cobertura a todas las instalaciones de la red de VA MS Centers of Excellence.
Helius Medical Technologies (NASDAQ:HSDT)는 Lovell Government Services를 통해 VA Healthcare System에 첫 번째 PoNS 시스템 판매를 발표했습니다. 이 판매는 23,844달러 (컨트롤러 16,499달러, 입 마스크 7,345달러)에 가격이 책정되었으며, VA 연방 조달 계약을 통한 운영 구현을 의미합니다.
PoNS 시스템은 물리치료와 함께 사용될 때 가벼운 내지 중등증 다발성 경화증 증상을 가진 성인의 보행 결핍을 치료하는 데 적합하며, 미국에서 MS를 앓고 있는 55,000명에서 70,000명의 재향군인을 위한 잠재적 시장을 목표로 하고 있습니다. 이 회사는 동부와 남동부의 VA 위치를 담당하는 영업 전문 인력을 보유하고 있으며, VA MS Centers of Excellence 네트워크 모든 시설로의 확장을 계획하고 있습니다.
Helius Medical Technologies (NASDAQ:HSDT) a annoncé sa première vente du système PoNS au VA Healthcare System via le distributeur Lovell Government Services. La vente, au prix de 23 844 $ (16 499 $ pour le contrôleur, 7 345 $ pour l'embout buccal), marque la mise en œuvre opérationnelle par le biais du contrat VA Federal Supply Schedule.
Le système PoNS, indiqué pour traiter le déficit de marche chez les adultes présentant des symptômes de SEP légers à modérés lorsqu'il est utilisé avec une thérapie physique, cible un marché potentiel de 55 000 à 70 000 vétérans vivant avec la SEP aux États-Unis. L'entreprise dispose de professionnels de la vente couvrant les sites VA le long de la côte Est et du Sud-Est, avec des projets d'élargir la couverture à tous les établissements du réseau VA MS Centers of Excellence.
Helius Medical Technologies (NASDAQ:HSDT) hat seinen ersten Verkauf des PoNS-Systems an das VA Healthcare System über den Distributor Lovell Government Services bekannt gegeben. Der Verkauf, der mit 23.844 US-Dollar (16.499 US-Dollar für den Controller, 7.345 US-Dollar für das Mundstück) bewertet ist, markiert die operative Umsetzung über den VA Federal Supply Schedule Vertrag.
Das PoNS-System, das zur Behandlung von Gangdefiziten bei Erwachsenen mit leichten bis mäßigen MS-Symptomen in Verbindung mit Physiotherapie angezeigt ist, richtet sich an einen potenziellen Markt von 55.000 bis 70.000 Veteranen, die in den USA mit MS leben. Das Unternehmen verfügt über Vertriebsprofis, die VA-Standorte an der Ostküste und im Südosten abdecken, und plant, die Abdeckung auf alle VA MS Centers of Excellence Netzwerkstandorte auszudehnen.
- First commercial sale to VA Healthcare System at $23,844
- Access to large potential market of 55,000-70,000 veterans with MS
- Established pricing evidence to support Medicare reimbursement discussions
- Expanding sales coverage across VA locations
- None.
Insights
The first VA sale of Helius Medical's PoNS System marks a crucial commercial milestone in the
The FSS contract approval streamlines future procurement processes and validates the pricing model. The strategic focus on VA MS Centers of Excellence, combined with the expanded sales coverage across the eastern U.S., positions Helius to capture a meaningful share of this specialized market segment. The established pricing through the VA system could accelerate broader insurance coverage and market adoption, potentially serving as a catalyst for revenue scaling beyond the VA market.
The VA system's adoption of the PoNS System represents a significant regulatory and reimbursement breakthrough. The formal inclusion in the Federal Supply Schedule (FSS) and GSA Advantage contracts establishes critical precedent for pricing and coverage decisions. This structured procurement pathway through contract #V797D-50450 provides a template for other federal healthcare systems and could influence private insurance policies.
The price point validation through a major federal healthcare system strengthens Helius's position in ongoing CMS discussions for Medicare coverage. This institutional backing from the VA healthcare system adds credibility to the therapy's medical necessity and could accelerate coverage decisions by other payers, potentially creating a domino effect in reimbursement policies across the healthcare landscape.
Initial order placed with Company’s distributor at contracted price and represents operational implementation through VA Federal Supply Schedule (FSS) Contract
NEWTOWN, Pa., Dec. 23, 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 announced the first PoNS System sale to the VA Healthcare System. The PoNS System sale through our distributor, Lovell Government Services (“Lovell”), was at the contracted price of
“We are excited to announce the first PoNS System sale to the VA and are proud to support advancing the treatment of gait deficit for Veterans with MS,” said Dane Andreeff, Helius President and Chief Executive Officer. “Since the approval of PoNS for inclusion on the Federal Supply Schedule contract, we have worked hard to integrate with the VA as an approved vendor to streamline future operations. This sale to one of the larger VA Centers of Excellence in MS, serves as a launching point for further penetration into this patient population of up to 70,000 veterans with MS as we continue to expand our sales coverage which currently extends across many of the VAs on the east coast and southeast. Additionally, this order provides valuable market pricing evidence that supports our efforts to advance discussions for broader Medicare reimbursement with CMS.”
PoNS is indicated in the U.S. for use as a short-term treatment of gait deficit in adults with mild-to-moderate symptoms from MS when used in conjunction with physical therapy. The VA estimates that between 55,000 and 70,000 veterans in the U.S. are living with MS. The Company is committed to supporting this community as demonstrated in a recent spotlight on KATU that featured veteran and PoNS user Kevin Byrne, whose inspiring journey underscores the potential of PoNS Therapy®. The Company now has a team of independent sales professionals covering many VA locations along the east coast and in the southeast and is working to further expand coverage to all VA MS Centers of Excellence (“MSCoE”) network facilities across the U.S.
The PoNS device was approved for inclusion on Lovell’s Veterans Affairs (VA) Federal Supply Schedule (FSS) and General Services Administration (GSA) Advantage contracts earlier in 2024. The contract award number #V797D-50450 enables the VA and other federal entities to purchase PoNS at pre-approved pricing via the VA’s FSS Medical Equipment and Surgical (Med/Surg) Contract at VA National Acquisition Center MedSurg Catalog and via the GSA Advantage online catalog at GSA Advantage. The PoNS system, Item # S1-001-02, is priced at
About Lovell® Government Services
Lovell Government Services has been a trusted SDVOSB vendor since 2013 with a proven track record of successfully introducing suppliers to the government market. Lovell is a two-time Inc. 5,000 honoree and leader in the federal space. They partner with medical and pharmaceutical companies looking to better serve Veteran and military patient populations, increase their federal revenue stream, and win government contracts. Learn more at www.lovellgov.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.
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 PoNS System sales to the VA, the Company’s future communications with CMS and the results of such communications, 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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