ARC-EX System offers new hope for individuals with chronic spinal cord injuries.
A Non-Invasive Breakthrough for Spinal Cord Therapy
Onward Medical has received FDA de novo clearance for its ARC-EX spinal cord stimulation (SCS) system. The device delivers targeted electrical stimulation transcutaneously to the spinal cord via electrodes placed on the back of the neck. This non-invasive approach enhances strength, movement, and function in upper limbs affected by chronic spinal cord injuries (SCI).
Promising Clinical Outcomes
Results from the Up-LIFT study demonstrated the system’s effectiveness:
- Primary endpoints met: The study achieved all safety and efficacy goals.
- Improved function: Significant gains in upper limb strength, movement, and sensation were observed in participants with chronic tetraplegia caused by cervical SCI.
The ARC-EX system’s non-invasive nature eliminates the need for surgical implantation, making it a more accessible and patient-friendly option.
Looking Ahead: Home Use and Global Expansion
- Home use approval: Onward anticipates FDA clearance for home use by mid-2025.
- CE mark: The company plans to pursue European regulatory approval in late 2025.
- Future pipeline: Onward is also developing the implantable ARC-IM SCS system and exploring advanced brain-computer interface (BCI) solutions powered by AI.
Transforming Lives After SCI
“This FDA clearance marks a new era for people with chronic spinal cord injury,” said Dave Marver, CEO of Onward Medical. “ARC-EX is the first approved therapy proven to improve hand strength and sensation after chronic SCI. We hope this is the first of many therapies to help individuals regain independence.”
With the ARC-EX system, Onward Medical is poised to redefine what’s possible for individuals living with paralysis and other movement disabilities.
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