ONWARD Medical N.V. (Euronext: ONWD), the medical technology company creating innovative therapies to restore movement, independence, and health in people with spinal cord injury (SCI), today reported topline results from the LIFT Home study, evaluating the safety and feasibility of ARC-EX Therapy when used at home. ARC-EX Therapy is a proprietary non-invasive spinal cord stimulation technology designed to restore movement and other functions in people with spinal cord injury (SCI) and other movement disabilities.
The Company recently reported its Up-LIFT pivotal study evaluating ARC-EX Therapy in clinics achieved its primary endpoint, demonstrating statistically significant and clinically meaningful improvement in upper extremity strength and function.
“Today’s results from the LIFT Home study support the potential for ARC-EX Therapy to be used safely at home, which would enable people with spinal cord injury to live even more independently,” said Dave Marver, CEO of ONWARD. “We expect to launch first in clinics, but as the community gains more experience with ARC-EX Therapy, we envision many patients will also want to use this technology at home.”
“To maximize recovery after spinal cord injury, it’s critical that we develop treatments that can be safely and effectively delivered in the home environment,” said Principal Investigator, Candy Tefertiller, PT, DPT, Ph.D., NCS, Executive Director of Research and Evaluation at Denver’s Craig Hospital. “Integrating home-based therapy not only facilitates opportunities for ongoing recovery, but also allows therapy to focus on more relevant activities for that specific individual.”
The LIFT Home study is a single-arm observational study. The main objective of the study is to evaluate the safety and feasibility of ARC-EX Therapy when used at home. Seventeen people were enrolled at five leading spinal cord injury research centers in the United States: Craig Hospital in Denver, Colorado, Shepherd Center in Atlanta, Georgia, Spaulding Research Institute in Boston, Massachusetts, University of Minnesota, and the University of Washington. Participants performed training on activities of daily living three times per week over a one-month period. Approximately 97% of these sessions were completed without usability issues, supporting the feasibility of home-based treatment. The absence of any device-related adverse events confirmed the favorable safety results observed during the Up-LIFT Study when ARC-EX Therapy was used in clinics.
ONWARD plans to discuss the findings from the LIFT Home study with regulatory authorities to define the appropriate approval pathway for home use, with a goal to facilitate access to ARC-EX Therapy for as long as needed without the burden of continued visits to a clinic.