ONWARD Medical Secures FDA Approval for First Non-Invasive Spinal Cord Stimulation System
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ONWARD Medical has reached a significant milestone in spinal cord injury (SCI) treatment, receiving FDA de novo classification and U.S. market authorization for its ARC-EX System. This innovative device is the first non-invasive technology approved to improve hand strength and sensation in individuals with chronic SCI, offering hope to a community often told recovery is not possible.
The ARC-EX System delivers programmed electrical stimulation to the spinal cord through external electrodes placed on the back of the neck. Unlike traditional spinal cord stimulation devices, it does not require surgery. This makes it accessible and transformative for individuals with chronic SCI, including those injured decades ago.
Clinical results published in Nature Medicine highlighted the system’s impact: 90% of participants showed improved hand strength or function, while 87% reported enhanced quality of life. Benefits included reduced spasms, better sleep, and improved upper-body sensation. “Regaining hand ability is the highest priority for people with paralysis, and this technology represents a tremendous step forward,” said Dr. Chet Moritz of the University of Washington.
Dave Marver, CEO of ONWARD Medical, described the FDA’s approval as a landmark moment: “For the first time, people with chronic SCI have an authorized therapy that addresses their needs. We hope this is the beginning of many advancements to restore independence.”
The ARC-EX System is currently cleared for clinical use, with home-use authorization expected by mid-2025. ONWARD Medical also plans to expand into Europe, targeting CE Mark certification in late 2025. Beyond ARC-EX, the company is developing other pioneering technologies, including the implantable ARC-IM system and a brain-computer interface (ARC-BCI) powered by artificial intelligence.
About ONWARD Medical
ONWARD Medical is a medical technology company creating therapies to restore movement, function, and independence in people with spinal cord injury (SCI) and movement disabilities. Building on more than a decade of scientific discovery, preclinical, and clinical research conducted at leading hospitals, rehabilitation clinics, and neuroscience laboratories, the Company has developed ARC Therapy, which has been awarded ten Breakthrough Device Designations from the US Food and Drug Administration (FDA).
ONWARD ARC Therapy is targeted, programmed spinal cord stimulation designed to be delivered by the Company’s external ARC-EX or implantable ARC-IM platforms. ARC Therapy can also be delivered by the Company’s ARC-BCI platform, which pairs the ARC-IM System with brain-computer interface (BCI) technology to restore movement after SCI with thought-driven control.
Use of non-invasive ARC-EX Therapy significantly improved upper limb function after SCI in the global pivotal Up-LIFT trial, with results published by Nature Medicine in May 2024. The Company has submitted its regulatory application to the FDA for clearance of the ARC-EX System in the US and is preparing for regulatory submission in Europe. In parallel, the Company is conducting clinical studies with its ARC-IM Therapy, which demonstrated positive interim clinical outcomes for improved blood pressure regulation following SCI. Other ongoing clinical studies focus on using ARC-IM Therapy to address mobility after SCI and gait challenges in Parkinson’s disease, as well as using the ARC-BCI platform to restore thought-driven movement of both upper and lower limbs after SCI.
Headquartered in Eindhoven, the Netherlands, ONWARD Medical has a Science and Engineering Center in Lausanne, Switzerland, and a US office in Boston, Massachusetts. The Company is listed on Euronext Paris, Brussels, and Amsterdam (ticker: ONWD).
➡️ Source: ONWARD Medical PR