Published Data Support Benefits of ONWARD ARC-IM Therapy

Two simultaneous publications in Nature and Nature Medicine add to the scientific and clinical evidence supporting ONWARD Medical N.V.’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 hypotensive symptom frequency and severity. 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 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, the authors identified the neuronal architecture of the spinal cord that forms after SCI and leads to autonomic dysreflexia (AD), an uncontrolled, life-threatening blood pressure elevation. Results showed that electrical stimulation targeting the specific spinal cord region responsible for blood pressure regulation—called the “Hemodynamic Hotspot”—can activate a competing neuronal architecture to safely and precisely regulate blood pressure.²

“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.”

Most 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

“The publications in Nature and Nature Medicine validate our commitment to introducing therapies that address critical autonomic functions impacted by spinal cord injury,” ONWARD Medical CEO Dave Marver said. “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.”

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 that manages 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 secured U.S. Food and Drug Administration (FDA) investigational device exemption (IDE) approval for the ARC-IM System. The approval allows the company to begin a global pivotal study (Empower BP) 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 neurorehabilitation and neurosurgical research centers in the United States, Canada, and Europe. Patient enrollment is expected to begin 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.

ONWARD Medical is a 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 hospitals, rehabilitation clinics, and neuroscience laboratories, the company developed ARC Therapy. It has subsequently been awarded 10 FDA Breakthrough Device designations. ONWARD Medical’s ARC-EX System is cleared for commercial sale in the United States and Europe. The company is also developing an investigational implantable system called ARC-IM 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, ONWARD Medical has a Science and Engineering Center in Switzerland and a U.S. office in Boston. The company is listed on Euronext Paris, Brussels, and Amsterdam and its U.S. ADRs can be traded on OTCQX.

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)