- ONWARD Medical (OTCQX: ONWRY) has filed a 510(k) application with the US FDA for home use expansion of its ARC-EX System.
- The company has also submitted a CE Mark application to enable commercialization in the EU and other countries.
- The one-year Pathfinder2 Study demonstrated significant improvements in participants using ARC-EX Therapy for spinal cord injuries.
ONWARD Medical (OTCQX: ONWRY), a leader in neurotechnology, has announced the submission of two regulatory applications for its ARC-EX System, which is designed to help spinal cord injury (SCI) patients improve hand sensation and strength. The company has filed a 510(k) application with the US Food and Drug Administration (FDA) to authorize the home use of this groundbreaking technology, which is currently the only FDA-cleared therapy for this purpose.
Simultaneously, ONWARD Medical has submitted an application for CE Mark certification in accordance with the European Union Medical Device Regulation (MDR). This submission aims to facilitate the commercialization of the ARC-EX System in the EU and other regions recognizing CE Marking. These applications, completed in June 2025, are pivotal in expanding access and market potential for ONWARD’s innovative solutions.
The company’s move follows the successful initial US clinical launch and strong early demand, pointing towards promising market expansion. Clearance for home use in the US could significantly broaden the reach and impact of the ARC-EX System, making it more accessible to those with SCI outside the clinical environment.
In support of these regulatory efforts, ONWARD has published positive results from the Pathfinder2 Study, featured in Neuromodulation: Technology at the Neural Interface. The study showcased significant functional improvements in participants, including enhanced upper body strength, trunk control, and balance, achieved through ARC-EX Therapy combined with activity-based rehabilitation.
Dave Marver, CEO of ONWARD Medical, expressed confidence in the company’s ability to execute its innovation roadmap, highlighting the potential market expansion and enhanced accessibility for SCI patients through these regulatory submissions.
As ONWARD Medical advances its mission to restore movement and independence for individuals with movement disabilities, these regulatory steps underscore the company's commitment to bringing life-changing therapies to a global market.
