Onward Medical Wins FDA Approval for ARC-EX, a Non-Invasive Spinal Cord Stimulator

Onward Medical has received de novo FDA approval for its ARC-EX system, marking the first non-invasive spinal cord stimulator designed specifically for spinal cord injury (SCI) patients. Unlike traditional stimulators requiring surgical implantation, ARC-EX delivers targeted, programmed spinal cord stimulation through non-invasive means, offering new hope to an estimated 300,000 SCI patients in the U.S. and seven million globally. The approval currently applies to clinical use, with plans for home use and European market expansion expected in 2025. Following the announcement, shares in the Netherlands-headquartered company, listed in Brussels, rose 7% at market open, with its market cap reaching $220.1 million.

ARC-EX demonstrated exceptional results in the Up-LIFT clinical trial, with 90% of participants improving strength or function and 87% reporting better quality of life. Benefits included reduced spasms, improved sleep, and enhanced upper body sensation. CEO of the Christopher and Dana Reeve Foundation, Maggie Goldberg, hailed the approval as a “watershed moment,” emphasizing the significance for SCI patients. Onward is also advancing its portfolio with ARC-IM, an implantable stimulator, and ARC-BCI, a brain-computer interface system, signaling a promising future for neuromodulation therapies.