Onward Wins FDA Nod for Blood Pressure Study with ARC-IM System

Onward Medical announced that the U.S. Food and Drug Administration (FDA) has approved an investigational device exemption (IDE) for its ARC-IM system. Now, the company can begin its Empower BP pivotal study, which will evaluate its implantable spinal stimulation system to address blood pressure instability after spinal cord injury (SCI).

Empower BP is the company’s second global pivotal study and the first to assess the implantable ARC-IM system. The study is expected to recruit about 20 neurorehabilitation and neurosurgical research centers in the U.S., Canada, and Europe, with the first patient enrollment expected before the end of 2025.

The study will target subjects 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).

The ARC-IM system is an implanted neuromodulation platform that delivers targeted and personalized spinal cord stimulation (SCS). It’s made up of the implanted Onward neurostimulator (IPG) and the ARC-IM thoracic lead, which is optimized for surgical placement in a region of the thoracic spinal cord called the “hemodynamic hotspot.” This location was first discovered by Onward’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.

According to Dr. James Guest, neurosurgeon and Professor of Neurological Surgery at the University of Miami, blood pressure instability—especially chronic low blood pressure—is one of the most hidden and unrecognized functional complications of SCI.

“It leaves people feeling unwell and can significantly impact their overall quality of life,” Dr. Guest told the press. “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 company released positive top-line interim clinical results from feasibility studies showing improved blood pressure regulation and hemodynamic stability after SCI. Participants in the study taking anti-hypotension drugs before the study also significantly reduced or discontinued their medication. Detailed interim results from these studies are anticipated to be published later this year.

Managing blood pressure instability is one of the unmet needs the FDA awarded the company for one of its ten breakthrough device designations.

“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.”

Last month, the company revealed it had submitted two regulatory applications for its ARC-EX system. The first is an FDA 510(k) application to expand its indication to home use. The second is a CE mark for commercialization in the EU.