Concurrent Publications in Nature and Nature Medicine Highlight Advances in Blood Pressure Regulation after Spinal Cord Injury Using ONWARD ARC-IM Therapy

Core Insights - ONWARD Medical N.V. has published significant findings in Nature and Nature Medicine, supporting the efficacy of its investigational ARC-IM System for treating blood pressure instability in individuals with spinal cord injuries (SCI) [1][6][7] Group 1: Clinical Findings - Multi-year clinical feasibility studies demonstrated that participants receiving ARC-IM Therapy experienced immediate and substantial increases in blood pressure, along with a reduction in hypotensive symptoms, leading to improved quality of life and greater engagement in daily activities [2][3] - The studies involved 14 participants from leading neurorehabilitation clinics across Switzerland, Canada, and the Netherlands, showing consistent benefits across all sites for up to two years post-implant [2][3] - Participants reported reduced fatigue, improved bowel management, and increased tolerance for upright postures, with many able to reduce or discontinue traditional low blood pressure treatments [3] Group 2: Mechanistic Insights - Research identified the neuronal architecture of the spinal cord that contributes to autonomic dysreflexia (AD), a dangerous condition characterized by uncontrolled high blood pressure [4][5] - Electrical stimulation targeting the "Hemodynamic Hotspot" in the spinal cord was shown to effectively regulate blood pressure by activating a competing neuronal architecture [4][8] Group 3: Market Implications - The majority of individuals with SCI experience blood pressure instability, with 78% of those with tetraplegia diagnosed with orthostatic hypotension, yet only 28% receiving treatment [5] - The findings from the publications validate ONWARD's commitment to addressing critical autonomic functions affected by SCI and support the upcoming Empower BP global pivotal study, which aims to further assess the safety and efficacy of the ARC-IM System [6][9] Group 4: Future Developments - The FDA has approved an investigational device exemption (IDE) for the ARC-IM System, allowing the initiation of the Empower BP study, which will involve at least 60 participants across 20 research centers in the US, Canada, and Europe [9] - The study will focus on participants with spinal cord injuries at levels C2-T6 and severities of AIS A-D, with first patient enrollment expected before the end of the year [9] Group 5: Company Overview - ONWARD Medical is a leading neurotechnology company focused on developing therapies to restore movement and independence in individuals with spinal cord injuries and other movement disabilities [11][12] - The company has received 10 Breakthrough Device designations from the FDA and has developed the ARC-EX System, which is already cleared for commercial sale in the US and Europe [11]