Onward Medical has submitted two major regulatory applications for its ARC-EX system.

The first is a U.S. Food and Drug Administration (FDA) 510(k) application to expand its indication to home use. The second is an application for CE mark clearance for commercialization in the EU. Both submissions were completed in June.

ARC-EX is the first, only FDA-cleared tech indicated to improve hand sensation and strength after spinal cord injury (SCI). After the successful first phase of its U.S. launch to clinics, Onward is seeking an FDA nod to broaden marketing for use at home.

The company said strong early demand and positive user feedback suggest it’s on track to meet 2025 expectations.

Onward is also preparing for ARC-EX’s commercialization through its CE mark submission. Once approved, the device would become available in the EU and other countries that recognize CE marking.

Earlier this year, the company also revealed publication of positive results from the Pathfinder2 study in Neuromodulation: Technology at the Neural Interface. The paper further expands clinical evidence supporting ARC-EX—one-year data demonstrated ARC-EX therapy with activity-based rehabilitation delivered significant functional benefits when given to people with SCI in community-based rehab centers.

Participants had continued gains in upper body strength, trunk control, and balance after one year of treatment, with no plateau in therapeutic benefit.

“These two submissions are further evidence of our ability to execute against our innovation roadmap,” said Dave Marver, CEO of Onward Medical. “Gaining regulatory authorization for ARC-EX in Europe and broadening the ARC-EX label in the US will greatly expand the market while offering improved and more convenient access for those with SCI.”

Earlier this year, the company achieved the first human implant of its investigational ARC-IM lumbar lead.