Onward Medical has successfully obtained FDA de novo clearance for its groundbreaking ARC-EX spinal cord stimulation (SCS) system, the company announced recently.
The ARC-EX SCS therapy utilizes programmed electrical pulses delivered transcutaneously to the spinal cord via electrodes positioned on the back of the neck. This innovative approach facilitates non-surgical treatment, enhancing upper limb strength, mobility, and function in individuals with spinal cord injuries (SCI). The FDA submission for ARC-EX took place in April.
Findings from the company’s Up-LIFT study demonstrated that ARC-EX not only met its primary safety and efficacy goals but also led to noticeable improvements in arm strength, functional abilities, and tactile sensation. The investigation focused on participants experiencing chronic tetraplegia due to cervical SCI.
Upon receiving FDA clearance, Onward plans to extend ARC-EX’s clinical use and envisions home use authorization by mid-2025. The company is also preparing to apply for CE mark approval in Europe, with hopes of finalizing the process by the latter half of 2025. Among its technological developments are additional innovations like the implantable ARC-IM SCS system and a research platform harnessing AI-driven brain-computer interface (BCI).
“The FDA’s de novo classification and subsequent approval to market the ARC-EX System in the United States marks a pivotal moment for those managing chronic spinal cord injuries,” noted Dave Marver, CEO of Onward Medical. “ARC-EX stands as the first validated therapeutic option promising improvements in hand strength and sensation following chronic SCI. It signifies a departure from the notion that these abilities cannot be regained post-injury.
“We aspire for this innovation to be the first in a series of solutions aimed at empowering individuals with spinal cord injuries to reclaim autonomy from paralysis and mobility impairments,” Marver added.