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 spinal cord injuries and related movement disabilities [1][2]. Group 1: Clinical Findings - Multi-year clinical feasibility studies published in Nature Medicine indicate that participants receiving ARC-IM Therapy experienced immediate increases in blood pressure and a reduction in hypotensive symptoms, leading to improved quality of life and engagement in daily activities [2][4]. - The studies involved 14 participants across neurorehabilitation clinics in Switzerland, Canada, and the Netherlands, showing consistent benefits such as reduced fatigue and improved bowel management over a two-year period post-implant [2][4]. - No serious device-related adverse events were reported during the studies, highlighting the safety of the ARC-IM Therapy [2]. Group 2: Mechanistic Insights - Research published in Nature identified the "Hemodynamic Hotspot" in the spinal cord, which is crucial for regulating blood pressure and can be targeted by electrical stimulation to manage blood pressure instability [3][5]. - A significant percentage of individuals with spinal cord injuries experience blood pressure instability, with 78% of tetraplegic patients diagnosed with orthostatic hypotension, yet only 28% receiving treatment [3][4]. Group 3: Future Developments - The FDA has granted an investigational device exemption for the ARC-IM System, allowing the initiation of the Empower BP global pivotal study, which aims to assess the safety and efficacy of this neurostimulation technology [6]. - The Empower BP study will involve at least 60 participants across 20 leading neurorehabilitation and neurosurgical centers in the US, Canada, and Europe, with first patient enrollment expected by the end of the year [6]. Group 4: Company Overview - ONWARD Medical is a leading neurotechnology company focused on developing therapies to restore movement and independence for individuals with spinal cord injuries and other movement disabilities [8]. - 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 [8].