Voices From The Community | Spinal Cord Injury & Paralysis

Empowering Independence: ONWARD ARC-EX System granted US market authorization by FDA

Written by Reeve Staff | Jan 24, 2025 3:27:19 PM

The Christopher & Dana Reeve Foundation hosted a panel discussion about the recent FDA market authorization for the ONWARD ARCEX System in the US. ARCEX is the first and only FDA-approved technology shown to improve hand strength and sensation after chronic spinal cord injury (SCI). 

Here are some key highlights of the ARCEX System from the Up-LIFT clinical trial¹: 

  • 90% of clinical trial participants showed improved strength or function in clinical trials 
  • Benefits seen up to 34 years post-injury in clinical trials 

Dr. Marco Baptista moderated the panel discussion with Up-LIFT principal investigators Drs. Chet Moritz and Candace Tefertiller, trial participants Sherown Campbell and Jessie Owen, and ONWARD Medical CEO Dave Marver and VP Clinical, Regulatory, and Quality Erika Ross Ellison. 

The ARCEX System is authorized only for professional use in the United States. ONWARD Medical will begin a limited release of the system in select rehabilitation centers starting in January 2025, with nationwide availability anticipated by April 2025. This phased approach is intended to ensure a safe and seamless integration of the new ARCEX System into daily clinical practice. More detailed information will be shared during the webinar. 

 

Highlights from the Webinar:  

  • Breakthrough Technology: The ARCEX System, the first FDA-approved device shown to improve hand strength and sensation in people with chronic SCI, is poised to revolutionize rehabilitation.  

  • Expert Insights: Hear perspectives from clinical investigators, trial participants, and ONWARD Medical leadership on the development, results, and phased rollout of ARCEX . 


Learn more here and sign up here for regular updates and information about the rehabilitation centers where the system will become available in the coming months. 

ONWARD will also be joining the Reeve Foundation at our upcoming Reeve Summit, March 10-12, 2025, in Denver, Colorado. Register at ChristopherReeve.org/ReeveSummit. 
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