ONWARD Medical N.V., the medical technology company creating innovative therapies to restore movement, independence, and health in people with spinal cord injury (SCI), reported interim clinical outcomes from the first 10 people treated to regulate blood pressure with implantable ARC Therapy, ONWARD’s targeted spinal cord stimulation technique. ARC Therapy immediately improved blood pressure levels for all participants; this benefit has been sustained for the duration of the current follow-up period. Participants have also reported improved quality of life, increased energy and vitality, and reduced dizziness.
Aaron Phillips, PhD, Associate Professor, Physiology and Pharmacology, Biomedical Engineering, Cardiac Sciences, Clinical Neurosciences, Cumming School of Medicine, University of Calgary, and the Principal Investigator of the HEMO study, said, “Low blood pressure has long been a hidden complication of spinal cord injury that often goes unrecognized and leaves people feeling unwell. It also potentially predisposes them to cardiovascular disease. The results with ARC Therapy are compelling and may open a new avenue to help people with spinal cord injury truly feel better, while also addressing heart health.”
The interim outcomes are from 10 people with spinal cord injury who were treated at clinical centers in Canada and Switzerland. In addition to a sustained increase in blood pressure levels, participants who were taking an anti-hypotension drug prior to entering the study were able to significantly reduce or discontinue their medication. Participants also reported improved general well-being: Participants reported a reduction in orthostatic hypotension, including reduced dizziness and improved energy, and those prone to fainting or light-headedness prior to implant indicated that such incidents declined dramatically following treatment with ARC Therapy. Participants continue to be followed, in one case for as long as three years, and the therapy remains beneficial in all cases.
Dave Marver, CEO of ONWARD, said, “We are excited by these highly promising outcomes, which reinforce our plan to further develop and bring ARC-IM to the market for this important indication. Today, there are limited and ineffective options for treating people with low blood pressure after spinal cord injury, and our therapy has the potential to address an issue that significantly impacts their quality of life.”
Many people with spinal cord injury experience hypotension, or low blood pressure. Hypotension may limit active participation in physical rehabilitation programs and facilitate the deterioration effects of immobilization and development of undesirable secondary medical complications.
Based on the promising interim outcomes from these feasibility studies, ONWARD is preparing to initiate further clinical trials to include U.S. participants in 2023.