ONWARD Medical N.V. (ONWRF) has announced the enrolment of the first participant in Empower BP, a pivotal global study designed to evaluate the safety and effectiveness of its investigational ARC-IM System for blood pressure instability in people living with chronic spinal cord injury.
The milestone was reached at Craig Hospital in Denver, Colorado, one of the leading centers participating in the trial.
Blood pressure instability is a frequent and serious complication of spinal cord injury, often presenting as chronic orthostatic hypotension or episodes of autonomic dysreflexia. These conditions can compromise cardiovascular health, hinder neurological recovery, and diminish quality of life.
ONWARD's ARC-IM Therapy aims to address this unmet need by delivering targeted spinal cord stimulation to restore hemodynamic stability.
The Empower BP study is structured as a randomized, double-blinded, sham-controlled trial and will involve approximately 20 neurorehabilitation and neurosurgical research centers across North America and Europe.
Investigators will assess whether ARC-IM Therapy can provide consistent improvements in blood pressure regulations, building on feasibility data published in Nature Medicine in September 2025.That earlier study showed immediate and sustained benefits, including reduced fatigue, improved bowel management, and enhanced tolerance of upright postures.
Dave Marver, Chief Executive Officer of ONWARD Medical, described the launch of Empower BP as a significant step forward. "The initiation of Empower BP marks another important step in our journey to restore independence for people with spinal cord injury," he said. "We are hopeful this study will provide the data needed to bring ARC-IM Therapy to hospitals and clinics worldwide."
Dr. Candy Tefertiller, Executive Director of Research and Evaluation at Craig Hospital and Principal Investigator of the study, underscored the importance of the trial. "Blood pressure instability is a silent yet debilitating complication of spinal cord injury," she noted. "We are eager to evaluate the potential of ARC-IM Therapy to improve hemodynamic stability through precise spinal cord stimulation."
The ARC-IM System consists of the ONWARD Neurostimulator and the ARC-IM Thoracic Lead, designed for surgical placement in the thoracic spinal cord region responsible for blood pressure regulation. While the ARC-EX System has already received clearance for commercial sale in the United States and Europe, ARC-IM remains investigational.
ONWARD Medical, headquartered in the Netherlands with operations in Switzerland and the United States, has built its ARC Therapy platform on decades of scientific discovery. The company has earned ten FDA Breakthrough Device Designations, reflecting the potential of its technology to transform care for people with spinal cord injury.
ONWRF has traded between GBp 109.88 and GBp 153.96 over the past year. The stock closed yesterday's trading at GBp 146, down 2.67%.
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