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Third-party tests from leading US lab confirm printed circuit board assembly (PCBA) conforms to prevailing international electrical standards, a requirement for commercial launch
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EINDHOVEN, the Netherlands, March 18, 2024 (GLOBE NEWSWIRE) -- ONWARD Medical N.V. (Euronext: ONWD), the medical technology company creating innovative spinal cord stimulation therapies to restore movement, function, and independence in people with spinal cord injury (SCI), today announces receipt of a positive report from a leading US-based medical equipment testing laboratory confirming its investigational ARC-EX System conforms to prevailing electrical standards, a requirement for commercial launch.
Last year, the Company announced its decision to update the ARC-EX printed circuit board assembly. With the positive testing report, the Company moves closer to meeting regulatory obligations for market launch.
The ONWARD ARC-EX System is designed to improve upper extremity movement after paralysis caused by spinal cord injury.
“The positive tests are an important milestone on our path to commercialize the external, non-invasive ARC-EX System in the US later this year,” said ONWARD Medical CEO Dave Marver. “We are now one step closer to bringing this breakthrough therapy to the SCI Community.”
To learn more about ONWARD Medical’s commitment to partnering with the SCI Community to develop innovative solutions for restoring movement, function, and independence after spinal cord injury, please visit ONWD.com.
*All ONWARD Medical devices and therapies, including but not limited to ARC-IM®, ARC-EX®, ARC-BCI™, and ARC Therapy™, alone or in combination with a brain-computer interface (BCI), are investigational and not available for commercial use.
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 science and preclinical research conducted at leading neuroscience laboratories, the Company has received ten Breakthrough Device Designations from the US Food and Drug Administration for its ARC Therapy™ platform.
ONWARD® ARC Therapy, which can be delivered by external ARC-EX® or implantable ARC-IM® systems, is designed to deliver targeted, programmed spinal cord stimulation. Positive results were presented in 2023 from the Company’s pivotal study, called Up-LIFT, evaluating the ability for transcutaneous ARC Therapy to improve upper extremity strength and function. The Company is now preparing regulatory approval submissions for ARC-EX for the US and Europe. In parallel, the Company is conducting studies with its implantable ARC-IM platform, which demonstrated positive interim clinical outcomes for improved blood pressure regulation, a component of hemodynamic instability, following SCI. Other ongoing studies include combination use of ARC-IM with a brain-computer interface (BCI) to address multiple symptoms of SCI.