On the heels of establishing itself as a leader in SCI research with the successful launch of the first external electrical stimulation device cleared by the FDA for home use, ONWARD Medical is on the verge of cementing that status with an exciting new approach that could help millions of people living with spinal cord injuries say goodbye to abdominal binders, compression garments and costly medicines. 

ARC-IM is the first “neuroprosthetic” system designed to help regulate blood pressure and reduce autonomic dysreflexia in people living with C3-T6 spinal cord injuries. Unlike the external ARC-EX system, which delivers stimulation through electrodes placed on the skin, ARC-IM is implanted. The system targets what ONWARD calls the “hemodynamic hotspot,” a region in the lower thoracic spinal cord containing a high concentration of neurons involved in regulating blood pressure. ONWARD says its researchers characterized this area in detail through early clinical work. 

To do this, ARC-IM relies on two implanted components — a neurostimulator and an implanted 16-array lead positioned in the epidural space above the spinal cord, over the hemodynamic hotspot — and a wearable belt that provides a way to recharge the stimulator and a connection that allows clinicians to adjust the stimulation. 

Findings from a preliminary study of 14 people with SCI who received the system showed immediate increases in blood pressure and reductions in the frequency and severity of hypotensive symptoms. Those findings were published in Nature Medicine. 

“As soon as they pressed start on the stimulator, I felt like my eyes were opening and I didn’t even know how closed my eyes were until that moment,” says Nuno, a C7 quad who participated in the study. “I could feel the blood going through my veins and I felt like I was alive again. This technology has impacted my life so much that I can tell you that I cannot live without it.” 

Analysis of self-reported symptoms in participants from four clinical studies showed that targeting the hemodynamic hotspot with electrical stimulation reduced headaches and heart palpitations, which are both directly related to dangerous increases in blood pressure. Importantly, the therapy had no detectable effect on the other warning signs such as goosebumps and sweating that many people rely on to know something is wrong. 

ARC-IM is now being tested in an FDA-approved clinical trial, called Empower BP, at 14 active sites — 13 in the United States and one in Canada — with additional sites planned. The first of what the company hopes to be 120 participants was implanted at Craig Hospital in the first quarter of 2026. If the study succeeds, ONWARD says FDA approval could be attained by the second half of 2028. 

Further down the line, ONWARD is working on a third project — the ARC-BCI System, a brain-control interface that reconnects communication between the brain and the body to restore thought-driven movement after paralysis. 

ONWARD is actively recruiting participants with chronic SCI for Empower BP. Interested parties can submit a form through ONWARD’s Empower BP study page. A study specialist will then determine whether the trial may be appropriate before formal screening and baseline assessments.