ONWARD Medical, a developer of spinal cord stimulation therapy, has announced a significant step towards the commercialisation of its ARC-EX System in the US.
The system is designed to improve upper extremity movement in people after paralysis as a result of spinal cord injury (SCI).
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Third-party tests from an undisclosed US-based medical equipment testing laboratory have confirmed that the investigational system conforms to current international electrical standards, a critical requirement for its market launch.
Last year, ONWARD Medical decided to update the ARC-EX printed circuit board assembly, and this latest positive testing report marks a pivotal moment in meeting regulatory standards for bringing the product to market.
The company secured ten breakthrough device designations from the US Food and Drug Administration for its ARC Therapy platform.
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The ARC Therapy can be delivered via the external ARC-EX or the implantable ARC-IM systems, designed to provide targeted spinal cord stimulation.
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By GlobalDataThe company is now focused on preparing regulatory approval submissions for ARC-EX in the US and Europe.
Concurrently, ONWARD Medical is conducting studies on its implantable ARC-IM platform.
ONWARD Medical CEO Dave Marver said: “The positive tests are an important milestone on our path to commercializing the external, non-invasive ARC-EX System in the US later this year.
“We are now one step closer to bringing this breakthrough therapy to the SCI Community.”
ONWARD Medical’s portfolio, including the ARC-IM, ARC-EX, ARC-BCI, and ARC Therapy, remains investigational and is not yet available for commercial use.
Last year, ONWARD Medical successfully made the first-in-human implant of its ARC-IM Stimulator, to restore upper extremity function after SCI.
Furthermore, the patient received a wireless brain-computer interface (BCI) to initiate thought-driven movement in combination with ARC-IM.
