FDA gives go ahead for ONWARD Medical spinal study
The FDA has approved a clinical study of an implantable device designed to stabilise blood pressure in people with spinal cord injury.
The ARC-IM System, a neurostimulation device, will be tested in the Empower BP pivotal study across about 20 research centres, with patient enrolment expected before the end of 2025.
Blood pressure instability affects more than 50 per cent of those with spinal cord injury (SCI) – around 350,000 people in the US and Europe – and can harm cardiovascular health and quality of life.
Dr James Guest is a neurosurgeon and professor of neurological surgery at the University of Miami.
He said: “Blood pressure instability, especially chronic low blood pressure, is one of the most hidden and unrecognised functional complications of spinal cord injury.
“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.”
ONWARD Medical, the Dutch company behind the device, received Investigational Device Exemption (IDE) approval from the Food and Drug Administration.
Based in Eindhoven, the firm develops therapies to restore movement and function for SCI patients.
The device uses neurostimulation – electrical signals delivered to specific nerves – to help regulate blood pressure, addressing what the company says is a major unmet need in SCI care.
The study will be global, randomised, double-blinded and sham-controlled, meaning some participants will receive a placebo treatment to ensure results are genuine.
Around 20 neurorehabilitation and neurosurgical research centres in the US, Canada and Europe will take part.
ONWARD has been developing its ARC Therapy over more than a decade of scientific discovery, preclinical research and clinical studies in hospitals, rehabilitation centres and neuroscience labs.
Dave Marver, chief executive officer of ONWARD, said: “This is an important milestone for ONWARD and the SCI community.
“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.”
