Onward Medical has received FDA de novo classification for its ARC-EX system, marking the first non-invasive spinal cord stimulator approved for use in patients with spinal cord injuries (SCI). This approval offers a new avenue for improving hand strength and sensation in individuals with chronic SCI. The ARC-EX system delivers targeted, programmed electrical stimulation to the spinal cord through electrodes placed on the back of the neck, providing a non-surgical alternative to implanted stimulators.
Clinical Trial Outcomes
The Up-LIFT study (NCT04697472), published in Nature Medicine, demonstrated significant benefits for patients using the ARC-EX system. Key findings include:
- 90% of participants experienced improvements in strength or function.
- 87% reported an improvement in their quality of life.
- Participants also reported reduced spasm frequency, improved sleep quality, and enhanced upper body sensation and sense of touch.
Notably, benefits were observed in patients with injuries sustained up to 34 years prior to the study. One participant, Sherown Campbell, who sustained a spinal cord injury in 2014, reported significant progress in mobility since starting treatment with the device.
Expert Commentary
Dave Marver, CEO of Onward Medical, stated, "For the first time, there is an approved therapy shown to improve hand strength and sensation after chronic SCI. No longer will people be sent home and told nothing can be done to help them regain these abilities after their injury."
Maggie Goldberg, CEO of the Christopher and Dana Reeve Foundation, hailed the approval as a "watershed moment" for the SCI community, expressing hope that it signals the beginning of further advancements in SCI treatment.
Device Details and Future Plans
The ARC-EX system is currently approved for clinical use, with Onward Medical planning to seek authorization for home use in mid-2025. The company also intends to pursue CE Mark certification for commercialization in Europe, with approval anticipated in the second half of 2025. Onward Medical is also developing the ARC-IM, an implantable spinal cord stimulation system, and ARC-BCI, a brain-computer interface system powered by AI, both of which are currently under investigation.
Market Context
According to the World Health Organization, SCI affects approximately seven million people worldwide, with an estimated 300,000 cases in the United States. A GlobalData market model forecasts the global neuromodulation device market to reach $11.4 billion by 2033, up from $6 billion in 2022, highlighting the growing demand for innovative solutions in this field.
