ONWARD Medical Receives US Market Authorization for its Spinal Cord Stimulation System

The ARC-EX System delivers programmed electrical stimulation through the skin to the spinal cord via electrodes placed on the back of the neck. The device is non-invasive and does not require surgery like other spinal cord stimulation devices. The system consists of an external stimulator and wireless programmer which stimulate the spinal cord via electrical pulses from electrodes placed on the back of the neck. The system parameters can be optimized for each patient's unique needs. 

Results of the Up-LIFT clinical study published in Nature Medicine showed that 90% of study participants improved strength or function, 87% reported improvement in quality of life, and benefits were observed up to 34 years post-injury. The study also reported less spasm frequency, improved sleep quality, and improved upper body sensation and sense of touch.

“With today’s FDA de novo classification and authorization to market the ARC-EX System in the US, a new era begins for people with chronic spinal cord injury. For the first time, there is an approved therapy shown to improve hand strength and sensation after chronic SCI,” said Dave Marver, CEO of ONWARD Medical. “We hope this is the first of many therapies we will introduce to help people regain independence from paralysis and other movement disabilities.”

The De Novo pathway, introduced by the FDA in 1997, allows companies to receive FDA clearance for low or medium risk medical devices with no existing predicate, or no substantial equivalence, ensuring safety and effectiveness through risk-based evaluation. It uses general or special controls when general controls alone are insufficient.

(Press release / SK)