ONWARD Medical has announced that its ARC-EX System has received de novo classification and marketing authorisation from the US Food and Drug Administration (FDA).
This milestone marks the first and only FDA-approved technology designed to improve hand strength and sensation for individuals living with chronic spinal cord injury (SCI).
The ARC-EX System provides programmed electrical stimulation through electrodes placed on the back of the neck. This non-invasive device delivers stimulation to the spinal cord without requiring surgical intervention, unlike other spinal cord stimulation systems.
The system has demonstrated significant benefits in clinical studies, including improvements in hand strength and sensation, reduced spasm frequency, enhanced sleep quality, and better upper body sensation.
Findings from the Up-LIFT clinical trial, published in Nature Medicine, revealed that 90% of participants experienced improved strength or function, with 87% reporting a better quality of life. These outcomes were observed even in individuals whose injuries occurred up to 34 years prior.
The study highlighted that regaining hand function is a priority for people living with paralysis, and the ARC-EX System offers a promising solution to address this need.
The company plans to expand the availability of the ARC-EX System. While current FDA authorisation permits its use in clinical settings, approval for home use is anticipated by mid-2025.
Additionally, efforts are underway to obtain CE Mark certification to enable commercialisation in Europe, with authorisation expected in the second half of 2025.
ONWARD Medical is working on a range of innovative technologies, including the investigational ARC-IM System and the ARC-BCI System. The latter integrates a brain-computer interface powered by artificial intelligence, representing a further advancement in SCI treatment.
Spinal cord injuries affect approximately seven million people globally, including over 300,000 in the United States. These injuries often result in tetraplegia, severely impacting the ability to perform basic tasks and leading to significant secondary complications.
The economic burden is substantial, with lifetime treatment costs for tetraplegia exceeding $5 million. Historically, options for recovery have been limited, particularly for those with long-term injuries.
The approval of the ARC-EX System marks a significant step forward in addressing these challenges and improving the quality of life for individuals with SCI.
Source: https://www.globenewswire.com/news-release/2024/12/19/3000089/0/en/ONWARD-Medical-Receives-FDA-De-Novo-Classification-and-US-Market-Authorization-for-World-s-First-Non-Invasive-Spinal-Cord-Stimulation-System-for-People-with-Chronic-Spinal-Cord-Inj.html
