ONWARD Medical Receives FDA IDE Approval to Initiate the Empower BP Pivotal Study with the ARC-IM System

Core Viewpoint - ONWARD Medical N.V. has received FDA approval for an investigational device exemption for its ARC-IM System, enabling the initiation of the Empower BP pivotal study to evaluate the safety and efficacy of its implantable spinal stimulation system for managing blood pressure instability after spinal cord injury (SCI) [2][7]. Group 1: Study Details - The Empower BP study is the second global pivotal study for ONWARD and the first to assess the ARC-IM System, involving approximately 20 leading neurorehabilitation and neurosurgical centers across the US, Canada, and Europe, with patient enrollment expected by year-end [3][7]. - The study will focus on participants with spinal cord injuries at levels C2-T6, with injury severities of AIS A-D, and those experiencing chronic orthostatic hypotension and episodes of autonomic dysreflexia [3]. Group 2: Market Need and Impact - Over 50% of individuals with SCI experience blood pressure instability, affecting nearly 350,000 people in the US and Europe, which can threaten neurological recovery and negatively impact cardiovascular health and quality of life [4][5]. - Addressing blood pressure instability is critical for improving long-term outcomes for SCI patients, as it is a significant but often unrecognized complication that can lead to increased cardiovascular disease risk [5][8]. Group 3: Technology Overview - The ARC-IM System is an implanted neuromodulation platform designed to deliver targeted spinal cord stimulation, specifically aimed at managing blood pressure instability in SCI patients [5][9]. - The system includes the ONWARD Neurostimulator and the ARC-IM Thoracic Lead, which is optimized for placement in the thoracic spinal cord's "Hemodynamic Hotspot," a location identified through research partnerships [5][6]. Group 4: Previous Results and Future Outlook - In December 2022, ONWARD announced positive interim clinical results from feasibility studies showing improved blood pressure regulation and hemodynamic stability after SCI, with participants reporting enhanced well-being and reduced symptoms of orthostatic hypotension [6]. - The FDA has awarded ONWARD one of its 10 Breakthrough Device Designations for the ARC-IM System, indicating its potential to address significant unmet medical needs and providing regulatory and reimbursement advantages [8].