- 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, 78% are diagnosed with orthostatic OH, yet only 28% receive treatment – and of those, 91% continue to experience symptoms.4 Blood pressure instability and persistent low blood pressure can threaten neurological recovery and negatively impact cardiovascular health and quality of life. The most frequent symptoms include dizziness, lightheadedness, blurred vision, and fatigue.5
“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
For Investor Inquiries:
investors@onwd.com
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)
Forward-Looking Statements
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.
