Dear Investors and Friends,
I am pleased to announce the first commercial sales of our ARC-EX System in the United States, coming just days after the US Food and Drug Administration (FDA) authorized marketing of the device on December 19, 2024. ARC-EX is the first and only FDA-approved technology indicated to improve hand strength and sensation in people with chronic spinal cord injury (SCI).
UW Medicine (University of Washington) is one of our first commercial customers, which is particularly meaningful since much of our foundational research on transcutaneous spinal cord stimulation was conducted there. Next Steps Chicago is the other purchaser, aligned with the Company’s objective to provide access to this breakthrough technology in community rehabilitation clinics as well as major academic research centers.
The ARC-EX System is currently authorized for clinic use in the United States, and we anticipate authorization for home use in 2025. We plan to seek CE Mark certification early this year, with a commercial launch in Europe expected in 2H 2025.
These sales are an important milestone for the company, demonstrating our ability to successfully translate scientific discovery into real-world impact for people with spinal cord injury.
Best regards,
Dave Marver
CEO
ARC-EX Indication for Use (US): The ARC-EX System is intended to deliver programmed, transcutaneous electrical spinal cord stimulation?in conjunction with functional task practice in the clinic?to improve hand sensation and strength in individuals between 18 and 75 years old that present with a chronic, non-progressive neurological deficit resulting from an incomplete spinal cord injury (C2-C8 inclusive).
Other Investigational Products: All other ONWARD Medical devices and therapies including ARC-IM and ARC-BCI are investigational and not available for commercial use.
Trademarks: ONWARD, ARC-EX, ARC-IM, ARC-BCI, and the stylized O-Logo are proprietary and registered trademarks of ONWARD Medical. Unauthorized use is strictly prohibited.