Onward Medical today announced two simultaneous publications supporting its investigational ARC-IM spinal cord stimulation (SCS) system.
The studies, published in Nature and Nature Medicine, add to the body of evidence supporting ARC-IM. The implanted neuromodulation platform delivers targeted and personalized spinal cord stimulation. It received FDA investigational device exemption last month. Ongoing studies evaluate the system’s ability to address blood pressure instability after spinal cord injury (SCI).
Results from multi-year clinical feasibility studies demonstrated immediate and robust increases in blood pressure with ARC-IM. They also showed reduced frequency and severity of hypotensive symptoms. Enhanced hemodynamic stability delivered by the therapy resulted in improved quality of life and greater engagement in rehabilitation and daily life activities, too.
Additional benefits observed included reduced fatigue, improved bowel management and increased tolerance of upright postures. Participants also reduced or discontinued traditional treatments for low blood pressure, including compression garments and medications. Investigators saw benefits through up to two years post-implant with no serious adverse events.
Onward said the studies enrolled 14 participants at leading neurorehabilitation clinics in Switzerland, Canada and the Netherlands. Investigators published their results in Nature Medicine.
The other publication in Nature saw the ability to identify the neuronal architecture of the spinal cord that forms after SCI and leads to autonomic dysreflexia (AD), an uncontrolled, life-threatening elevation of blood pressure. Results showed that electrical stimulation targeting the specific region of the spinal cord responsible for blood pressure regulation can activate a competing neuronal architecture to safely and precisely regulate blood pressure.
“Today’s landmark publications in Nature and Nature Medicine validate our commitment to introducing therapies that address critical autonomic functions impacted by spinal cord injury,” said Dave Marver, CEO of Onward Medical. “These promising results bolster our mechanistic understanding and demonstrate that the investigational ARC-IM System has the potential to meaningfully improve quality of life and positively impact one’s ability to participate in daily activities after SCI. These data also demonstrate the effectiveness of ARC-IM Therapy for managing blood pressure instability in advance of our planned initiation of the Empower BP global pivotal study later this year.”
