ONWARD Medical N.V. is continuing to enroll patients in a study assessing the safety and effectiveness of its ARC-IM System in managing symptomatic blood pressure instability in chronic spinal cord injury (SCI) patients.

Empower BP is the first global pivotal study to evaluate the company’s investigational implantable spinal cord stimulation system. The randomized, double-blinded, sham-controlled trial will involve participants across approximately 20 neurorehabilitation and neurosurgical research centers in the United States, Canada, France, Germany, Spain, and the United Kingdom. The study targets individuals with injuries at spinal cord levels C2-T6 and injury severities of AIS A-D. The first participant was enrolled over the winter at Craig Hospital in Denver, Colo.

“The initiation of Empower BP marks another significant milestone in our journey to restore critical autonomic functions impacted by spinal cord injury,” ONWARD Medical CEO Dave Marver said. “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 dysreflexia.¹ 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 targeted placement within thoracic spinal cord regions that contain a high concentration of neurons responsible for regulating blood pressure. Published in Nature Medicine last fall, detailed results from multi-year clinical feasibility studies show that participants who received ARC-IM Therapy experienced immediate and robust blood pressure increases, 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. The benefits lasted for the studies’ duration—up to two years after the implant.⁴

ONWARD Medical is a neurotechnology company pioneering therapies to restore movement, function, and independence in patients suffering from SCI 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 its proprietary ARC Therapy. It has subsequently been awarded 10 U.S. Food and Drug Administration Breakthrough Device Designations. The company’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, 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, ONWARD Medical operates 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 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