Onward Medical announced the first commercial sales of its ARC-EX system in the U.S.

This comes just days after the U.S. Food and Drug Administration (FDA) awarded de novo classification to the ARC-EX spinal cord stimulation system. ARC-EX is the first, only FDA approved technology indicated to improve hand strength and sensation in patients with a chronic spinal cord injury.

UW Medicine purchased one of the systems in late December 2024, where it is now available.

“Having witnessed the evolution of this therapy from early research in our labs to an FDA-approved technology, we are thrilled to now offer this groundbreaking treatment to patients at UW Medicine,” said Chet Moritz, Ph.D., professor of Rehabilitation Medicine at the University of Washington School of Medicine. “This type of treatment has the potential to significantly improve hand strength, sensation, and independence for individuals living with spinal cord injury, and we are proud to be the first center to launch this treatment at Harborview Medical Center in Seattle.”

One of the initial ARC-EX systems was sold to Next Steps Chicago. Onward said this aligns with its objective to offer access to the technology in community rehabilitation clinical and major academic research centers.

“Partnering with ONWARD Medical marks a significant milestone in our mission to redefine recovery, and to innovatively provide the best possible care for those with spinal cord injuries,” said Maryleen K. Jones, PT, DHS, NCS, Executive Director of Clinical Operations at Next Steps of Chicago. “This technology could change lives by offering new avenues for recovery that were previously unimaginable.”

The ARC-EX system is currently authorized for clinic use in the U.S., and the company anticipates authorization for home use in 2025. Onward plans to seek CE mark certification in early 2025, with commercial launch in Europe anticipated in H2 2025.

“The first commercial sales of our ARC-EX System are a pivotal moment in our mission to help people with spinal cord injury, demonstrating our ability to successfully translate scientific discovery into real-world impact for people with spinal cord injury,” said Dave Marver, CEO of ONWARD Medical.

The company is also developing a pipeline of technologies, including its investigational implantable ARC-IM system, and its investigational ARC-BCI system, an implanted platform that uses a brain-computer interface (BCI) powered by artificial intelligence (AI).