ONWARD Medical Submits FDA 510(k) Application for Home Use of ARC-EX Spinal Cord Stimulation System
核心洞察
ONWARD Medical (搜索) has submitted a 510(k) application to the FDA seeking clearance to expand the ARC-EX System (搜索) indication for home use, potentially broadening access to this spinal cord injury (搜索) therapy.
The company simultaneously filed a CE Mark application to enable commercialization of the ARC-EX System (搜索) in the European Union and other countries recognizing CE marking.
The ARC-EX System (搜索) is currently the first and only FDA-cleared technology indicated to improve hand sensation and strength after spinal cord injury (搜索).
ONWARD Medical (搜索) N.V. has submitted dual regulatory applications to expand access to its ARC-EX System (搜索), a transcutaneous electrical spinal cord (搜索) stimulation device for treating spinal cord injury (搜索) patients. The neurotechnology company filed a 510(k) application with the US Food and Drug Administration seeking clearance to expand the system's indication for home use, while simultaneously submitting a CE Mark application to enable commercialization in the European Union.
The ARC-EX System (搜索) represents the first and only FDA-cleared technology indicated to improve hand sensation and strength after spinal cord injury (搜索). Currently approved for clinic-based use, the system delivers programmed transcutaneous electrical spinal cord (搜索) stimulation in conjunction with functional task practice to individuals aged 18-75 with chronic, non-progressive neurological deficits from incomplete spinal cord injuries (C2-C8 inclusive).
Regulatory Strategy and Market Expansion
Following the successful initial phase of its US clinical launch, ONWARD is pursuing FDA clearance to expand marketing of the ARC-EX System (搜索) for home use. According to the company, strong early demand and positive feedback from users suggest they are on track to meet 2025 expectations. Home use clearance would significantly broaden access to this innovative technology for spinal cord injury (搜索) patients.
"These two submissions are further evidence of our ability to execute against our innovation roadmap," said Dave Marver, Chief Executive Officer of ONWARD Medical (搜索). "Gaining regulatory authorization for ARC-EX in Europe and broadening the ARC-EX label in the US will greatly expand the market while offering improved and more convenient access for those with SCI."
Clinical Evidence Supporting Expansion
The regulatory submissions are supported by positive results from the investigator-sponsored Pathfinder2 Study, published in Neuromodulation: Technology at the Neural Interface. The peer-reviewed one-year trial demonstrated that ARC-EX Therapy combined with activity-based rehabilitation delivered significant functional improvements when administered to people with spinal cord injury (搜索) in community-based rehabilitation centers.
Participants in the study experienced continued gains in upper body strength, trunk control, and balance after one year of treatment, with no plateau in therapeutic benefit observed. This clinical evidence further expands the body of research supporting the ARC-EX System (搜索)'s therapeutic potential.
Technology and Development Pipeline
ONWARD Medical (搜索) has developed ARC Therapy based on more than a decade of scientific discovery, preclinical research, and clinical studies conducted at leading hospitals, rehabilitation clinics, and neuroscience laboratories. The company's ARC Therapy platform has been awarded ten Breakthrough Device Designations from the US FDA.
Beyond the commercially available ARC-EX System (搜索), the company is developing an investigational implantable system called ARC-IM with and without an implanted brain-computer interface (BCI). These investigational products remain unavailable for commercial use as they continue through development and regulatory processes.
Company Profile and Market Position
Headquartered in the Netherlands with a Science and Engineering Center in Switzerland and a US office in Boston, Massachusetts, ONWARD Medical (搜索) positions itself as the leading neurotechnology company pioneering therapies to restore movement, function, and independence in people with spinal cord injury (搜索) and other movement disabilities. The company is listed on Euronext Paris, Brussels, and Amsterdam (ticker: ONWD) with US ADRs trading on OTCQX (ticker: ONWRY).
The dual regulatory submissions, completed in June 2025, represent significant milestones as the company advances its mission to bring breakthrough therapies to people with spinal cord injury (搜索) worldwide. If approved, the expanded indications would mark a substantial step forward in making neurostimulation therapy more accessible to patients in both clinical and home settings.