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

Core Insights - ONWARD Medical N.V. has initiated the Empower BP study, a pivotal global study to assess the safety and effectiveness of the ARC-IM System for managing blood pressure instability in individuals with chronic spinal cord injury (SCI) [1][2][7] Group 1: Study Overview - Empower BP is the first global pivotal study evaluating the implantable ARC-IM System, involving approximately 20 leading neurorehabilitation and neurosurgical research centers across the US, Canada, France, Germany, Spain, and the UK [2][7] - The study targets individuals with spinal cord injuries at levels C2-T6 and severities of AIS A-D, with the first participant enrolled at Craig Hospital in Denver, Colorado [2][7] Group 2: Clinical Significance - The ARC-IM System aims to address unmet needs after SCI, particularly symptomatic blood pressure instability, which affects 78% of individuals with tetraplegia, yet only 28% receive treatment [3][4] - Chronic low blood pressure can threaten neurological recovery and negatively impact cardiovascular health, leading to symptoms such as dizziness, lightheadedness, and fatigue [3][4] Group 3: Previous Research Findings - Clinical feasibility results published in Nature Medicine indicated that participants receiving ARC-IM Therapy experienced immediate increases in blood pressure and reduced hypotensive symptoms, leading to improved quality of life and greater engagement in rehabilitation activities [4][6] - Benefits included reduced fatigue, improved bowel management, and increased tolerance of upright postures, with participants able to reduce or discontinue traditional low blood pressure treatments [4][6] Group 4: Company Background - ONWARD Medical is a leading neurotechnology company focused on restoring movement, function, and independence for individuals with spinal cord injuries and other movement disabilities, having received 10 Breakthrough Device Designations from the FDA [6][9] - The company is headquartered in the Netherlands, with additional facilities in Switzerland and the US, and is publicly listed on Euronext and OTCQX [9]