ONWARD Medical Announces First Participant Enrolled in Global Pivotal Study Evaluating ARC-IM System to Address Blood Pressure Instability After Spinal Cord Injury

• Empower BP is a landmark global pivotal study evaluating the safety and effectiveness of the implantable ARC-IM^® System to address blood pressure instability after spinal cord injury (SCI)
• Blood pressure instability is a key unmet need after SCI, with a significant impact on cardiovascular health and quality of life
• The first participant was enrolled at Craig Hospital in Denver, Colorado, USA
  

EINDHOVEN, the Netherlands, Feb. 04, 2026 (GLOBE NEWSWIRE) — ONWARD Medical N.V. (Euronext: ONWD and US OTCQX: ONWRY), the neurotechnology company pioneering spinal cord stimulation therapies to restore movement, function, and independence, today announces the enrollment of the first participant in Empower BP, a global pivotal study assessing the safety and effectiveness of the investigational ARC-IM^® System in managing symptomatic blood pressure instability in people with chronic spinal cord injury (SCI).

Empower BP is the first global pivotal study to evaluate the Company’s implantable spinal cord stimulation system. The randomized, double-blinded, sham-controlled study is expected to involve participants across approximately 20 leading neurorehabilitation and neurosurgical research centers in the US, Canada, France, Germany, Spain, and the UK. The study targets individuals with injuries at spinal cord levels C2-T6 and injury severities of AIS A-D. The first participant was enrolled at Craig Hospital in Denver, Colorado.

“The initiation of Empower BP marks another significant milestone in our journey to restore critical autonomic functions impacted by spinal cord injury,” said Dave Marver, CEO of ONWARD Medical. “The ARC-IM System is designed to address several unmet needs after SCI, including symptomatic blood pressure instability. The clinical feasibility results published last year in Nature Medicine were outstanding, and we are hopeful Empower BP will provide the data needed to bring this important therapy to hospitals and clinics worldwide.”

Blood pressure instability is a key unmet need after SCI, characterized by chronic orthostatic hypotension and episodes of autonomic dysreflexia¹. Among individuals with tetraplegia, 78% are diagnosed with orthostatic hypotension, yet only 28% receive treatment – and of those, 91% continue to experience symptoms including dizziness, lightheadedness, blurred vision, and fatigue. Over time, persistent low blood pressure can threaten neurological recovery and negatively impact cardiovascular health.^2,3

“Blood pressure instability is a silent yet debilitating complication of spinal cord injury, with serious consequences for cardiovascular health and quality of life,” said Dr. Candy Tefertiller, Executive Director of Research and Evaluation at Craig Hospital and Empower BP Principal Investigator. “We are eager to evaluate the potential of ARC-IM Therapy to improve hemodynamic stability through precise stimulation of the spinal cord region responsible for blood pressure regulation.”

The Company’s ARC-IM System comprises the implanted ONWARD Neurostimulator and the ARC-IM Thoracic Lead, optimized for surgical placement in the specific region of the thoracic spinal cord containing a high density of neurons that regulate blood pressure. Published in Nature Medicine in September 2025, detailed 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. 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 for the duration of the studies, which lasted up to two years following implant.⁴

To learn more about the Empower BP study and view a list of active centers in your area, please visit the following webpage.

About ONWARD Medical

ONWARD Medical is the leading neurotechnology company pioneering therapies to restore movement, function, and independence in people with spinal cord injuries (SCI) 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 its proprietary 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).

To learn more about ONWARD Medical’s commitment to partnering with the spinal cord injury community to develop innovative solutions for restoring movement, function, and independence after spinal cord injury, please visit ONWD.com.

To be kept informed about the Company’s technologies, research studies, 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. 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
2. 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
3. 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)
4. 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

Disclaimer

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. ARC-IM is limited by United States law to investigational use.