Core Viewpoint - ONWARD Medical N.V. has initiated the Empower BP study, a pivotal global trial 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][5]. 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][5]. - 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][5]. Group 2: Clinical Significance - The ARC-IM System aims to address unmet needs related to blood pressure instability after SCI, which is characterized by chronic orthostatic hypotension and episodes of autonomic dysreflexia [3][5]. - Among individuals with tetraplegia, 78% are diagnosed with orthostatic hypotension, yet only 28% receive treatment, and of those treated, 91% continue to experience symptoms such as dizziness and fatigue [3][5]. Group 3: Expected Outcomes - Previous clinical feasibility results published in Nature Medicine indicated that participants receiving ARC-IM Therapy experienced significant increases in blood pressure and reduced hypotensive symptoms, leading to improved quality of life and greater engagement in rehabilitation activities [3][4]. - Benefits observed included reduced fatigue, improved bowel management, and increased tolerance of upright postures, with participants able to reduce or discontinue traditional low blood pressure treatments [3][4]. Group 4: Company Background - ONWARD Medical is a leading neurotechnology company focused on developing therapies to restore movement, function, and independence for individuals with spinal cord injuries and other movement disabilities [4][6]. - The company has received 10 Breakthrough Device Designations from the FDA for its proprietary ARC Therapy, which is based on extensive scientific research and clinical studies [4].