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Home » Reach Neuro wins FDA breakthrough nod for movement restoration platform

Reach Neuro wins FDA breakthrough nod for movement restoration platform

April 10, 2023 By Sean Whooley

Reach Neuro Avantis University of Pittsburgh spinal cord stimulation SCS electrodes
The Avantis system from Reach Neuro. [Screenshot obtained from Pitt video demonstration]
Reach Neuro announced today that it received FDA breakthrough device designation for its Avantis platform for restoring movement.

Avantis uses small electrical impulses delivered to the spinal cord. It helps to restore shoulder, arm and hand movement in individuals with impairment due to chronic stroke.

Pittsburgh-based Reach Neuro said its system directly restores a patient’s ability to control movement. This provides immediate relief and enables patients to return to therapy and improve further. Avantis’ early evidence demonstrates effectiveness in chronic stroke patients even up to nine years after their stroke. It enables them to regain the use of their arm and hand, strengthening muscle activity without imposing unintended movements.

The spinout from the University of Pittsburgh and Carnegie Mellon University is currently testing the technology in an NIH-funded clinical trial.

Recently published findings demonstrated 40% and 108% improvements in grip strength in the first two study participants, respectively. The subjects demonstrated up to 124% improvement in joint strength. They performed reaching movements more quickly and successfully performed functional tasks. These included lifting objects, eating with a fork, and opening a lock.

Some improvements remained up to one month after the study, even without stimulation. Reach Neuro believes patients will likely benefit from a chronic implant, though.

“We are excited about the FDA’s recognition of our technology’s potential to change the lives of millions of people living with disability,” said Marc Powell, CEO and co-founder of Reach Neuro. “The breakthrough device designation is an incredible opportunity to work closely with FDA experts to expedite the clinical translation of the Avantis system.”

Filed Under: Food & Drug Administration (FDA), Implants, Neurological, Neuromodulation/Neurostimulation, Regulatory/Compliance Tagged With: FDA, Reach Neuro

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About Sean Whooley

Sean Whooley is a senior editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at [email protected].

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