ONWARD Medical receives FDA authorization for its spinal cord stimulation system

ONWARD Medical has achieved a significant milestone with FDA de novo classification and market authorization for its non-invasive ARC-EX System, the first technology approved to enhance hand strength and sensation after chronic spinal cord injury.

ONWARD Medical, a leader in spinal cord stimulation therapies, has received FDA de novo classification and authorization to market its ARC-EX System in the United States. This approval represents a breakthrough in the treatment of chronic spinal cord injuries, offering the first FDA-approved technology shown to improve hand strength and sensation for individuals with long-term SCI.

The ARC-EX System provides programmed electrical stimulation to the spinal cord through electrodes placed on the back of the neck, delivering therapy in a completely non-invasive manner. Unlike traditional spinal cord stimulation devices that require surgery, the ARC-EX System consists of an external stimulator and wireless programmer, allowing parameters to be tailored to each patient’s needs.

The ARC-EX System’s approval follows the success of the Up-LIFT clinical study, published in Nature Medicine. The study demonstrated that 90% of participants experienced improved strength or function, and 87% reported a higher quality of life. Benefits, including reduced spasm frequency, improved sleep, and enhanced sensation, were observed in participants with injuries as long as 34 years ago.

A new standard in spinal cord therapy

“This authorization marks the beginning of a new era for individuals living with chronic spinal cord injuries,” said Dave Marver, CEO of ONWARD Medical. “The ARC-EX System represents a critical step forward in restoring independence for those affected by paralysis and other movement disabilities.”

Authorized under the FDA’s De Novo pathway, the ARC-EX System is classified as a low-to-medium-risk device with no prior predicate, ensuring safety and effectiveness through rigorous evaluation.