ONWARD Medical N.V. (Euronext: ONWD and US ADR: ONWRY), the leading neurotechnology company pioneering therapies to restore movement, function, and independence in people with spinal cord injury and other movement disabilities, today announces that the US Food and Drug Administration (FDA) has approved an investigational device exemption for the ARC-IM System. With this approval, the Company can initiate the Empower BP pivotal study to assess the safety and efficacy of its implantable spinal stimulation system to address blood pressure instability after SCI.
Empower BP is the Company’s second global pivotal study, and the first to evaluate the implantable ARC-IM System. The randomized, double-blinded, sham-controlled study is expected to involve approximately 20 leading neurorehabilitation and neurosurgical research centers across the US, Canada and Europe, with first patient enrollment anticipated before the end of the year. The study will target participants with injuries at spinal cord levels C2-T6, injury severities of AIS A-D, and blood pressure instability characterized by chronic orthostatic hypotension (OH) and episodes of autonomic dysreflexia (AD).
“This is an important milestone for ONWARD and the SCI community,” said Dave Marver, CEO of ONWARD. “Our ARC-IM System is designed to address several unmet needs, including blood pressure instability which is a major recovery target after spinal cord injury. With this IDE approval, we continue to advance our innovation pipeline and inspire realistic hope in restoring autonomic functions and independence after SCI and other movement disabilities.”
Over 50% of people with SCI experience blood pressure instability, affecting nearly 350,000 people in the US and Europe. Blood pressure instability and persistent low blood pressure can threaten neurological recovery and negatively impact cardiovascular health and quality of life. The most frequent symptoms include dizziness, lightheadedness, blurred vision and fatigue.
“Blood pressure instability, especially chronic low blood pressure, is one of the most hidden and unrecognized functional complications of spinal cord injury,” explains Dr. James Guest, neurosurgeon and Professor of Neurological Surgery at the University of Miami. “It leaves people feeling unwell and can significantly impact their overall quality of life. Blood pressure instability also increases the risk of cardiovascular disease, making addressing this unmet need critical for improving the long-term outcomes of SCI.”
The ONWARD ARC-IM System is an implanted neuromodulation platform designed to deliver targeted and personalized spinal cord stimulation. It is the first neuroprosthetic system designed to manage blood pressure instability in people with SCI. It comprises the implanted ONWARD Neurostimulator (IPG) and the ARC-IM Thoracic Lead. The ARC-IM Thoracic Lead is optimized for surgical placement in a specific region of the thoracic spinal cord, called the “Hemodynamic Hotspot“. The location was first discovered by the Company’s research partners at the Swiss Federal Institute of Technology Lausanne (EPFL), Centre Hospitalier Universitaire Vaudois (CHUV), and the University of Calgary in a study published in Nature in January 2021.
In December 2022, the Company announced positive top-line interim clinical results from its feasibility studies showing improved blood pressure regulation and improved hemodynamic stability after SCI. In addition to immediate and sustained improved blood pressure levels, participants taking anti-hypotension drugs prior to the study significantly reduced or discontinued their medication. Participants also reported improved general well-being and a reduction in orthostatic hypotension, including reduced dizziness and increased energy. Detailed interim results from these studies are expected to be published later this year.
Managing blood pressure instability is among the major unmet needs for which the FDA has awarded the Company one of its 10 Breakthrough Device Designations. This award is reserved for novel, cutting-edge therapies addressing unmet needs and provides potential regulatory and reimbursement benefits.
