ONWARD Medical Files 510(k) with US FDA for ARC-EX System Home Use and Submits CE Mark Application
ONWARD Medical (OTCQX: ONWRY) has announced two major regulatory submissions for its ARC-EX System, a breakthrough therapy for spinal cord injury (SCI) patients. The company has filed a 510(k) application with the FDA seeking clearance for home use expansion in the United States, where it is currently the only FDA-cleared technology for improving hand sensation and strength after SCI.
In parallel, ONWARD has submitted a CE Mark application under the European Union Medical Device Regulation (MDR) to enable commercialization in the EU and other countries recognizing CE Marking. These submissions, completed in June 2025, follow the successful initial phase of the US clinical launch and strong early demand.
Supporting these applications, the company recently published positive results from the Pathfinder2 Study in Neuromodulation: Technology at the Neural Interface. The one-year trial demonstrated significant functional improvements in participants, including enhanced upper body strength, trunk control, and balance, with no plateau in therapeutic benefits when ARC-EX Therapy was combined with activity-based rehabilitation.
ONWARD Medical (OTCQX: ONWRY) ha annunciato due importanti sottomissioni regolatorie per il suo sistema ARC-EX, una terapia innovativa per i pazienti con lesioni del midollo spinale (SCI). L'azienda ha presentato una domanda 510(k) alla FDA per ottenere l'autorizzazione all'uso domestico negli Stati Uniti, dove attualmente 猫 l'unica tecnologia approvata dalla FDA per migliorare la sensibilit脿 e la forza della mano dopo una SCI.
Parallelamente, ONWARD ha inoltrato una richiesta di marcatura CE ai sensi del Regolamento sui dispositivi medici dell'Unione Europea (MDR) per consentire la commercializzazione nell'UE e in altri paesi che riconoscono la marcatura CE. Queste sottomissioni, completate nel giugno 2025, seguono la fase iniziale di successo del lancio clinico negli USA e la forte domanda iniziale.
A supporto di queste domande, l'azienda ha recentemente pubblicato risultati positivi dallo studio Pathfinder2 su Neuromodulation: Technology at the Neural Interface. Il trial di un anno ha mostrato miglioramenti funzionali significativi nei partecipanti, inclusi un aumento della forza della parte superiore del corpo, controllo del tronco e equilibrio, senza alcun plateau nei benefici terapeutici quando la terapia ARC-EX 猫 stata combinata con la riabilitazione basata sull'attivit脿.
ONWARD Medical (OTCQX: ONWRY) ha anunciado dos importantes presentaciones regulatorias para su sistema ARC-EX, una terapia innovadora para pacientes con lesiones de la m茅dula espinal (SCI). La compa帽铆a ha presentado una solicitud 510(k) ante la FDA para obtener la autorizaci贸n para uso en el hogar en Estados Unidos, donde actualmente es la 煤nica tecnolog铆a aprobada por la FDA para mejorar la sensibilidad y fuerza de la mano tras una SCI.
Paralelamente, ONWARD ha presentado una solicitud de Marcado CE bajo el Reglamento de Dispositivos M茅dicos de la Uni贸n Europea (MDR) para permitir la comercializaci贸n en la UE y otros pa铆ses que reconocen el Marcado CE. Estas presentaciones, completadas en junio de 2025, siguen a la exitosa fase inicial del lanzamiento cl铆nico en EE. UU. y a una fuerte demanda temprana.
Apoyando estas solicitudes, la compa帽铆a public贸 recientemente resultados positivos del estudio Pathfinder2 en Neuromodulaci贸n: Tecnolog铆a en la Interfaz Neural. El ensayo de un a帽o demostr贸 mejoras funcionales significativas en los participantes, incluyendo mayor fuerza en la parte superior del cuerpo, control del tronco y equilibrio, sin alcanzar un estancamiento en los beneficios terap茅uticos cuando la terapia ARC-EX se combin贸 con rehabilitaci贸n basada en la actividad.
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霃欖嫓鞐� ONWARD電� 鞙犽熃 鞐绊暕 鞚橂旮瓣赴 攴滌爼(MDR)鞐� 霐半澕 CE 毵堩伂 鞁犾箔靹滊ゼ 鞝滌稖頃橃棳 EU 氚� CE 毵堩伂毳� 鞚胳爼頃橂姅 旮绊儉 甑皜鞐愳劀 靸侅毄頇旊ゼ 臧�電ロ晿瓴� 頄堨姷雼堧嫟. 鞚� 鞝滌稖鞚� 2025雲� 6鞗� 鞕勲霅橃棃鞙茧┌, 氙戈淡 鞛勳儊 於滌嫓 齑堦赴 靹标车瓿� 臧曧暅 齑堦赴 靾橃殧鞐� 霐半ジ 瓴冹瀰雼堧嫟.
鞚� 鞁犾箔鞚� 霋冯皼旃晿旮� 鞙勴暣 須岇偓電� 斓滉芳 Neuromodulation: Technology at the Neural Interface鞐� Pathfinder2 鞐瓣惮鞚� 旮嶌爼鞝� 瓴瓣臣毳� 氚滍憸頄堨姷雼堧嫟. 1雲勱皠鞚� 鞛勳儊 鞁滍棙鞐愳劀 彀戈皜鞛愲摛鞚� 靸侅泊 攴茧牓, 氇疙喌 臁办爤 氚� 攴犿槙鞚� 韥矊 頄レ儊霅橃棃鞙茧┌, ARC-EX 旃橂鞕� 頇滊彊 旮半皹 鞛櫆鞚� 氤戫枆頃� 霑� 旃橂 須臣臧� 鞝曥泊霅橃 鞎婌晿鞚岇潉 氤挫棳欤检棃鞀惦媹雼�.
ONWARD Medical (OTCQX : ONWRY) a annonc茅 deux soumissions r茅glementaires majeures pour son syst猫me ARC-EX, une th茅rapie r茅volutionnaire pour les patients atteints de l茅sions de la moelle 茅pini猫re (SCI). La soci茅t茅 a d茅pos茅 une demande 510(k) aupr猫s de la FDA pour obtenir l'autorisation d'茅largir l'usage 脿 domicile aux 脡tats-Unis, o霉 elle est actuellement la seule technologie approuv茅e par la FDA pour am茅liorer la sensation et la force de la main apr猫s une SCI.
Parall猫lement, ONWARD a soumis une demande de marquage CE conform茅ment au R猫glement europ茅en sur les dispositifs m茅dicaux (MDR) afin de permettre la commercialisation dans l'UE et dans d'autres pays reconnaissant le marquage CE. Ces soumissions, finalis茅es en juin 2025, font suite 脿 la phase initiale r茅ussie du lancement clinique aux 脡tats-Unis et 脿 une forte demande pr茅coce.
Pour appuyer ces demandes, la soci茅t茅 a r茅cemment publi茅 des r茅sultats positifs de l'茅tude Pathfinder2 dans Neuromodulation : Technology at the Neural Interface. L'essai d'un an a d茅montr茅 des am茅liorations fonctionnelles significatives chez les participants, notamment une meilleure force du haut du corps, un meilleur contr么le du tronc et un meilleur 茅quilibre, sans plateau des b茅n茅fices th茅rapeutiques lorsque la th茅rapie ARC-EX 茅tait combin茅e 脿 une r茅茅ducation bas茅e sur l'activit茅.
ONWARD Medical (OTCQX: ONWRY) hat zwei bedeutende regulatorische Antr盲ge f眉r sein ARC-EX-System angek眉ndigt, eine bahnbrechende Therapie f眉r Patienten mit R眉ckenmarksverletzungen (SCI). Das Unternehmen hat bei der FDA eine 510(k)-Anmeldung eingereicht, um die Zulassung f眉r die h盲usliche Anwendung in den USA zu erhalten, wo es derzeit die einzige von der FDA zugelassene Technologie zur Verbesserung von Handempfindung und -kraft nach SCI ist.
Parallel dazu hat ONWARD einen Antrag auf CE-Kennzeichnung gem盲脽 der Medizinprodukteverordnung (MDR) der Europ盲ischen Union eingereicht, um den Vertrieb in der EU und in anderen L盲ndern, die die CE-Kennzeichnung anerkennen, zu erm枚glichen. Diese Antr盲ge, die im Juni 2025 abgeschlossen wurden, folgen auf die erfolgreiche Anfangsphase der klinischen Markteinf眉hrung in den USA und die starke fr眉he Nachfrage.
Zur Unterst眉tzung dieser Antr盲ge ver枚ffentlichte das Unternehmen k眉rzlich positive Ergebnisse der Pathfinder2-Studie in Neuromodulation: Technology at the Neural Interface. Die einj盲hrige Studie zeigte signifikante funktionelle Verbesserungen bei den Teilnehmern, darunter verbesserte Oberk枚rperkraft, Rumpfstabilit盲t und Gleichgewicht, ohne eine Abflachung der therapeutischen Vorteile, wenn die ARC-EX-Therapie mit aktivit盲tsbasierter Rehabilitation kombiniert wurde.
- First and only FDA-cleared technology for improving hand sensation and strength after SCI
- Strong early demand and positive feedback from initial US clinical launch
- Positive one-year trial results showing continued patient improvements with no therapeutic plateau
- Potential market expansion through home use authorization and EU commercialization
- None.
- FDA 510(k) application submitted to allow marketing of the ARC-EX庐 System for home use in the United States
- CE Mark application filed with notified body to enable commercialization of the ARC-EX System in the European Union and other countries
EINDHOVEN, the Netherlands, July 01, 2025 (GLOBE NEWSWIRE) -- ONWARD Medical N.V. (Euronext: ONWD and US OTCQX: ONWRY), the leading neurotechnology company pioneering therapies to restore movement, function, and independence in people with spinal cord injury (SCI) and other movement disabilities, today announced the submission of two major regulatory applications for its ARC-EX System. The Company has submitted a 510(k) application to the US Food and Drug Administration (FDA) seeking clearance to expand its indication for home use. In parallel, ONWARD has filed an application with the notified body for CE Mark certification in accordance with the European Union Medical Device Regulation (MDR) to enable commercialization of the ARC-EX System in the EU. Completed in June, these submissions represent significant milestones as the Company advances its mission to bring breakthrough therapies to people with SCI around the world.
The ARC-EX System is the first and only FDA-cleared technology indicated to improve hand sensation and strength after SCI. Following the successful initial phase of its US launch to clinics, ONWARD is pursuing FDA clearance to expand marketing of the ARC-EX System for use at home. Strong early demand and positive feedback from users suggest the Company is on track to meet its 2025 expectations. Clearance for home use would significantly broaden access to this innovative technology.
Simultaneously, ONWARD is preparing for the commercialization of the ARC-EX System through its CE Mark submission. Once approved, the ARC-EX System would be available in the European Union and other countries recognizing CE Marking.
鈥淭hese two submissions are further evidence of our ability to execute against our innovation roadmap,鈥� said Dave Marver, Chief Executive Officer of ONWARD Medical. 鈥淕aining regulatory authorization for ARC-EX in Europe and broadening the ARC-EX label in the US will greatly expand the market while offering improved and more convenient access for those with SCI.鈥�
Earlier this year, ONWARD also announced the publication of positive results from the investigator-sponsored Pathfinder2 Study in Neuromodulation: Technology at the Neural Interface. This peer-reviewed paper further expands the body of clinical evidence supporting the ARC-EX System. The one-year trial demonstrated that ARC-EX Therapy combined with activity-based rehabilitation delivered significant functional improvements when administered to people with SCI in community-based rehabilitation centers. Participants experienced continued gains in upper body strength, trunk control, and balance after one year of treatment, with no plateau in therapeutic benefit1.
About ONWARD Medical
ONWARD Medical is the leading neurotechnology company pioneering therapies to restore movement, function and independence in people with spinal cord injury and other movement disabilities. Building on more than a decade of scientific discovery, preclinical research, and clinical studies conducted at leading hospitals, rehabilitation clinics, and neuroscience laboratories, the Company has developed ARC Therapy, which has been awarded ten Breakthrough Device Designations from the US FDA. The Company鈥檚 ARC-EX System is cleared for commercial sale in the US. In addition, the Company is developing an investigational implantable system called ARC-IM with and without an implanted brain-computer interface (BCI).
Headquartered in the Netherlands, the Company has a Science and Engineering Center in Switzerland and a US office in Boston, Massachusetts. The Company is listed on Euronext Paris, Brussels, and Amsterdam (ticker: ONWD) and its US ADRs can be traded on OTCQX (ticker: ONWRY).
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Disclaimer听听
Certain statements, beliefs, and opinions in this press release are forward-looking, which reflect the Company鈥檚 or, as appropriate, the Company directors鈥� current expectations and projections about future events. By their nature, forward-looking statements involve several risks, uncertainties, and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties, and assumptions could adversely affect the outcome and financial effects of the plans and events described herein. A multitude of factors including, but not limited to, delays in regulatory approvals, changes in demand, competition, and technology, can cause actual events, performance, or results to differ significantly from any anticipated development. Forward-looking statements contained in this press release regarding past trends or activities should not be taken as a representation that such trends or activities will continue in the future. As a result, the Company expressly disclaims any obligation or undertaking to release any update or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions, or circumstances on which these forward-looking statements are based. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such person鈥檚 officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.
Trademarks: ONWARD, ARC-EX, ARC-IM, ARC-BCI, and the stylized O-Logo are proprietary and registered trademarks of ONWARD Medical. Unauthorized use is strictly prohibited.
1ARC-EX Indication for Use (US): The ARC-EX System is intended to deliver programmed, transcutaneous electrical spinal cord stimulation in conjunction with functional task practice in the clinic to improve hand sensation and strength in individuals between 18 and 75 years old that present with a chronic, non-progressive neurological deficit resulting from an incomplete spinal cord injury (C2-C8 inclusive).
Other Investigational Products: All other ONWARD Medical devices and therapies including ARC-IM and ARC-BCI are investigational and not available for commercial use.
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