Concurrent Publications in Nature and Nature Medicine Highlight Advances in Blood Pressure Regulation after Spinal Cord Injury Using ONWARD ARC-IM Therapy
ONWARD Medical (US ADR: ONWRY) has achieved a significant milestone with concurrent publications in Nature and Nature Medicine showcasing advances in blood pressure regulation for spinal cord injury (SCI) patients using their ARC-IM® Therapy. Clinical feasibility studies involving 14 participants demonstrated immediate improvements in blood pressure stability and reduced hypotensive symptoms.
The Nature Medicine study revealed participants experienced enhanced hemodynamic stability, improved quality of life, and better engagement in daily activities, with benefits lasting up to two years post-implant. The Nature publication identified the spinal cord's neuronal architecture and demonstrated how electrical stimulation of the "Hemodynamic Hotspot" can safely regulate blood pressure.
ONWARD has received FDA approval for an investigational device exemption (IDE) and plans to initiate the Empower BP global pivotal trial later this year, involving 60 participants across 20 research centers in the US, Canada, and Europe.
ONWARD Medical (US ADR: ONWRY) ha raggiunto una tappa significativa con pubblicazioni contemporanee su Nature e Nature Medicine che mostrano progressi nel controllo della pressione sanguigna per i pazienti con lesione del midollo spinale (SCI) utilizzando la loro ARC-IM® Therapy. Studi clinici di fattibilità che hanno coinvolto 14 partecipanti hanno evidenziato miglioramenti immediati nella stabilità della pressione sanguigna e nella riduzione dei sintomi ipotensivi.
Lo studio Nature Medicine ha rivelato una maggiore stabilità emodinamica, una migliore qualità della vita e una maggiore partecipazione alle attività quotidiane, con benefici fino a due anni dopo l'impianto. La pubblicazione Nature ha identificato l'architettura neuronale del midollo e dimostrato come la stimolazione elettrica del “Hemodynamic Hotspot” possa regolare la pressione sanguigna in modo sicuro.
ONWARD ha ottenuto l'approvazione FDA per un’esenzione da dispositivo investigativo (IDE) e prevede di avviare quest'anno lo Empower BP global pivotal trial, coinvolgendo 60 partecipanti presso 20 centri di ricerca negli Stati Uniti, in Canada e in Europa.
ONWARD Medical (US ADR: ONWRY) ha logrado un hito significativo con publicaciones concurrentes en Nature y Nature Medicine que muestran avances en la regulación de la presión arterial para pacientes con lesión de la médula espinal (SCI) utilizando su ARC-IM® Therapy. Los estudios de viabilidad clínica que involucraron a 14 participantes demostraron mejoras inmediatas en la estabilidad de la presión arterial y reducción de los síntomas hipotensivos.
El estudio de Nature Medicine reveló que los participantes experimentaron una mayor estabilidad hemodinámica, mejor calidad de vida y mejor participación en las actividades diarias, con beneficios que duraron hasta dos años después del implante. La publicación de Nature identificó la arquitectura neuronal de la médula espinal y mostró cómo la estimulación eléctrica del “Hemodynamic Hotspot” puede regular la presión arterial de forma segura.
ONWARD ha recibido la aprobación de la FDA para una exención de dispositivo en investigación (IDE) y planea iniciar este año el ensayo global Empower BP, que implicará 60 participantes en 20 centros de investigación en EE. UU., Canadá y Europa.
ONWARD Medical (US ADR: ONWRY)가 ARC-IM® Therapy를 사용해 척수손상(SCI) 환자의 혈압 조절에 대한 발전을 보여주는 Nature와 Nature Medicine의 동시 발표로 중요한 이정표를 달성했습니다. 14명 참여를 포함한 임상 실현 가능성 연구에서 혈압 안정성의 즉각적 개선과 저혈압 증상의 감소가 입증되었습니다.
Nature Medicine 연구는 참가자들이 혈역학적 안정성이 향상되고 삶의 질이 개선되며 일상 활동 참여가 증가했고, 효과가 임 implant 후 2년까지 지속되었음을 보여주었습니다. Nature 발표는 척수의 신경구조를 확인하고 Hemodynamic Hotspot의 전기 자극이 혈압을 안전하게 조절할 수 있음을 입증했습니다.
ONWARD는 연구용 기기 면제(IDE)에 대한 FDA 승인을 받았으며 올해 말 Empower BP 글로벌 결정적 시험를 시작할 계획이며, 미국, 캐나다 및 유럽의 20개 연구센터에서 60명 참가자가 참여합니다.
ONWARD Medical (US ADR: ONWRY) a atteint une étape importante avec des publications simultanées dans Nature et Nature Medicine montrant des avancées dans la régulation de la pression artérielle chez les patients atteints de lésions de la moelle épinière (SCI) utilisant leur ARC-IM® Therapy. Des études cliniques de faisabilité impliquant 14 participants ont démontré des améliorations immédiates de la stabilité de la pression artérielle et une réduction des symptômes d’hypotension.
L’étude Nature Medicine a révélé une meilleure stabilité hémodynamique, une amélioration de la qualité de vie et une meilleure participation aux activités quotidiennes, avec des bénéfices jusqu’à deux ans après l’implant. La publication Nature a identifié l’architecture neuronale de la moelle épinière et a montré comment la stimulation électrique du « Hemodynamic Hotspot » peut réguler la pression artérielle en toute sécurité.
ONWARD a obtenu l’approbation FDA pour une exemption d’appareil d’investigation (IDE) et prévoit d’initier cette année l’essai global Empower BP, impliquant 60 participants dans 20 centres de recherche aux États‑Unis, au Canada et en Europe.
ONWARD Medical (US ADR: ONWRY) hat einen bedeutenden Meilenstein erreicht mit parallelen Publikationen in Nature und Nature Medicine, die Fortschritte bei der Blutdruckregulierung bei Schlaganfallpatienten mit Rückenmarksverletzungen (SCI) mittels ihrer ARC-IM® Therapy zeigen. Klinische Machbarkeitsstudien mit 14 Teilnehmern demonstrierten sofortige Verbesserungen der Blutdruckstabilität und eine Verringerung hypotensiver Symptome.
Die Nature Medicine-Studie zeigte, dass die Teilnehmer eine verbesserte hämodynamische Stabilität, eine gesteigerte Lebensqualität und eine bessere Teilnahme an Alltagsaktivitäten erfuhren, mit Vorteilen von bis zu zwei Jahre nach dem Implantat. Die Nature-Veröffentlichung identifizierte die neuronale Architektur des Rückenmarks und zeigte, wie die elektrische Stimulation des „Hemodynamic Hotspot“ den Blutdruck sicher regulieren kann.
ONWARD hat die FDA-Zulassung für eine Investigational Device Exemption (IDE) erhalten und plant, noch in diesem Jahr die Empower BP global pivotal trial zu starten, an der 60 Teilnehmer aus 20 Forschungszentren in den USA, Kanada und Europa teilnehmen werden.
ONWARD Medical (US ADR: ONWRY) حققت خطوة كبيرة مع نشرين متزامنين في Nature و Nature Medicine يعرضان تقدمات في تنظيم ضغط الدم لمرضى إصابة الحبل الشوكي (SCI) باستخدام ARC-IM® Therapy. أظهرت دراسات جسامة سريرية شملت 14 مشاركاً تحسنات فورية في استقرار ضغط الدم وتقليل أعراض انخفاض الضغط.
الكشف في دراسة Nature Medicine أظهر أن المشاركين شهدوا استقراراً هيموديناميكياً محسنًا، وتحسناً في جودة الحياة، ومشاركة أفضل في الأنشطة اليومية، مع فائدة تدوم حتى سنتين بعد الزرع. كما بيّنت نشر Nature بنية الحبل الشوكي العصبية وأظهرت كيف يمكن للتحفيز الكهربائي لـ“Hemodynamic Hotspot” تنظيم ضغط الدم بأمان.
تلقت ONWARD موافقة FDA على استثناء جهاز بحثي (IDE)، وتخطّط لبدء تجربة Empower BP العالمية الحاسمة في وقت لاحق من هذا العام، بمشاركة 60 مشاركاً في 20 مركز بحثي في الولايات المتحدة وكندا وأوروبا.
ONWARD Medical (US ADR: ONWRY) 在与 ARC-IM® Therapy 相关的血压调控方面取得重大突破，并在 Nature 和 Nature Medicine 同步发表研究，涉及脊髓损伤(SCI)患者。包含 14 名参与者 的临床可行性研究显示血压稳定性显著改善、低血压症状减少。
在 Nature Medicine 的研究中，参与者表现出更好的血流动力学稳定性、生活质量提升，以及日常活动参与度提高，获益可持续至 植入后两年。Nature 的论文则揭示了脊髓的神经结构，并演示了通过对“Hemodynamic Hotspot”的电刺激可以安全地调节血压。
ONWARD 已获得用于研究性器械豁免的 FDA 批准（IDE），计划在今年晚些时候启动 Empower BP 全球关键性试验，在美国、加拿大和欧洲的 20 个研究中心 共招募 60 名参与者。
- Clinical studies showed immediate and robust increases in blood pressure with benefits lasting up to 2 years
- No serious device-related adverse events reported in the feasibility studies
- FDA approval received for investigational device exemption (IDE)
- Large addressable market with 78% of tetraplegic patients diagnosed with orthostatic hypotension
- Only 14 participants in initial feasibility studies, requiring larger trials for validation
- Upcoming Empower BP trial still needs to confirm safety and efficacy in larger population
- Detailed results from clinical feasibility studies show immediate improvement in blood pressure stability and durable reduction of hypotensive symptoms, resulting in improved quality of life
- Most people living with spinal cord injury experience blood pressure instability, which represents a key unmet need
- Today’s concurrent publications provide clinical evidence for ARC-IM® Therapy ahead of the Company’s planned initiation of the Empower BP global pivotal trial later this year
EINDHOVEN, The Netherlands, Sept. 18, 2025 (GLOBE NEWSWIRE) -- ONWARD Medical N.V. (Euronext: ONWD – US ADR: ONWRY), the leading neurotechnology company pioneering therapies to restore movement, function, and independence in people with spinal cord injuries (SCI) and other movement disabilities, today announces two simultaneous landmark publications in Nature and Nature Medicine, adding to the compelling body of scientific and clinical evidence supporting the Company’s investigational ARC-IM System.
Published in Nature Medicine, results from multi-year clinical feasibility studies show that participants who received ARC-IM Therapy saw immediate and robust increases in blood pressure, as well as reduced frequency and severity of hypotensive symptoms. The enhanced hemodynamic stability resulted in improved quality of life and greater engagement in rehabilitation and daily life activities. The studies enrolled 14 participants at leading neurorehabilitation clinics in Switzerland, Canada, and the Netherlands.1
Additional benefits included reduced fatigue, improved bowel management, and increased tolerance of upright postures. Participants reduced or discontinued traditional treatments for low blood pressure, including compression garments and medications. Benefits were observed throughout the studies for up to two years post-implant, and were consistent across study sites. No serious device-related adverse events were reported.
In another publication simultaneously published in Nature, authors were able to identify the neuronal architecture of the spinal cord that forms after SCI and leads to autonomic dysreflexia (AD), an uncontrolled, life-threatening elevation of blood pressure. Results showed that electrical stimulation targeting the specific region of the spinal cord responsible for blood pressure regulation, called the “Hemodynamic Hotspot”, can activate a competing neuronal architecture to safely and precisely regulate blood pressure.2
A majority of people living with SCI experience blood pressure instability, characterized by chronic orthostatic hypotension (OH) and episodes of autonomic dysreflexia.3 Among individuals with tetraplegia,
“Today’s landmark publications in Nature and Nature Medicine validate our commitment to introducing therapies that address critical autonomic functions impacted by spinal cord injury,” said Dave Marver, Chief Executive Officer of ONWARD Medical. “These promising results bolster our mechanistic understanding and demonstrate that the investigational ARC-IM System has the potential to meaningfully improve quality of life and positively impact one’s ability to participate in daily activities after SCI. These data also demonstrate the effectiveness of ARC-IM Therapy for managing blood pressure instability in advance of our planned initiation of the Empower BP global pivotal study later this year.”
"These results are a significant breakthrough for managing blood pressure instability, one of the key recovery targets after spinal cord injury,” said Dr. Aaron Phillips, neuroscientist and Director of the RESTORE Network at the University of Calgary. “We have demonstrated that ARC-IM Therapy can improve hemodynamic stability by delivering precise electrical stimulation to the specific region of the spinal cord responsible for blood pressure regulation, addressing both persistent low blood pressure and episodes of uncontrolled, life-threatening high blood pressure.”
The ONWARD ARC-IM System is an implanted neuromodulation platform designed to deliver targeted and personalized spinal cord stimulation. It is the first neuroprosthetic system designed to manage blood pressure instability in people with SCI. It comprises the implanted ONWARD Neurostimulator (IPG) and the ARC-IM Thoracic Lead, optimized for surgical placement in the specific region of the thoracic spinal cord (T10-T12) containing a high density of neurons that regulate blood pressure. The Hemodynamic Hotspot is the optimal site for precise stimulation to address blood pressure instability after SCI.
ONWARD recently announced that the FDA has approved an investigational device exemption (IDE) for the ARC-IM System. This approval allows the initiation of Empower BP, a global pivotal study to assess the safety and efficacy of the implantable neurostimulation technology to address blood pressure instability after SCI. Empower BP is a randomized, double-blind, sham-controlled study expected to involve a minimum of 60 participants in 20 leading neurorehabilitation and neurosurgical research centers across the US, Canada, and Europe. First patient enrollment is anticipated before the end of the year. The study will target participants with injuries at spinal cord levels C2-T6 and injury severities of AIS A-D.
To stay informed about ONWARD’s research studies, technologies, and the availability of therapies in your area, please complete this webform.
About ONWARD Medical
ONWARD Medical is the leading neurotechnology company pioneering therapies to restore movement, function, and independence in people with spinal cord injuries and other movement disabilities. Building on decades of scientific discovery, preclinical research, and clinical studies conducted at leading hospitals, rehabilitation clinics, and neuroscience laboratories, the Company developed ARC Therapy. It has subsequently been awarded 10 Breakthrough Device designations from the FDA. The Company’s ARC-EX® System is cleared for commercial sale in the US and Europe. The Company is also developing an investigational implantable system called ARC-IM®, designed to address several unmet needs, including blood pressure instability after spinal cord injury. It can also be paired with a brain-computer interface (BCI) and artificial intelligence (AI) to restore thought-driven movement.
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). For more information, please visit ONWD.com.
To stay informed about ONWARD’s research studies, technologies, and the availability of therapies in your area, please complete this webform.
For Media Inquiries:
Sébastien Cros, VP Communications
media@onwd.com
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References:
1. Phillips, A.A., Gandhi, A.P., Hankov, N. et al. An implantable system to restore hemodynamic stability after spinal cord injury. Nat Med 31, 2946–2957 (2025). https://doi.org/10.1038/s41591-025-03614-w
2. Soriano, J.E., Hudelle, R., Mahe, L. et al. A neuronal architecture underlying autonomic dysreflexia. Nature (2025). https://doi.org/10.1038/s41586-025-09487-w
3. Katzelnick CG et al. Blood Pressure Instability in Persons With SCI: Evidence From a 30-Day Home Monitoring Observation. Am J Hypertens. 2019 Sep 24;32(10):938-944
4. Noreau, L. et al. Development and assessment of a community follow-up questionnaire for the Rick Hansen spinal cord injury registry. Archives of Physical Medicine and Rehabilitation 94, 1753–1765. ISSN: 0003-9993
5. Carlozzi, N. E. et al. Impact of blood pressure dysregulation on health-related quality of life in persons with spinal cord injury: development of a conceptual model. Arch. Phys. Med. Rehabil. 94, 1721–1730 (2013)
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Certain statements, beliefs, and opinions in this press release are forward-looking, which reflect the Company’s or, as appropriate, the Company directors’ 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’s 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.
Investigational Products: ARC-IM and ARC-BCI are investigational and not available for commercial use.
FAQ
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