Reach Neuro has been granted a Breakthrough Device designation by the US Food and Drug Administration (FDA) for its Avantis platform, which uses small electrical impulses delivered to the spinal cord to help restore shoulder, arm and hand movement to individuals with impairment due to chronic stroke.
The Avantis system directly restores a patient’s ability to control movement—not only giving immediate relief, but also making it possible to return to therapy and continue making even further improvements, according to a Reach Neuro press release.
Reach Neuro was founded in 2021 as a spinout company of the University of Pittsburgh and Carnegie Mellon University (both Pittsburgh, USA), where the technology is currently being tested in a National Institutes of Health (NIH)-funded clinical trial in collaboration with the University of Pittsburgh Medical Center (UPMC).
The team recently published a manuscript in the journal Nature Medicine describing the results from the first two study participants. In the study, subjects showed 40% and 108% improvements in grip strength, respectively, and up to 124% improvement in joint strength. These improvements enabled them to perform reaching movements more quickly and smoothly than without stimulation (30–40% faster). Participants were also able to perform functional tasks like lifting objects, eating with a fork and opening a lock.
Surprisingly—as per Reach Neuro’s release—the researchers observed that some improvements were retained up to one month after the study, even without stimulation. However, patients will likely benefit from having the implant chronically.
“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.”
Reach Neuro claims that early evidence shows that the Avantis system can be effective in chronic stroke patients, even up to nine years after their stroke, which is well outside the six-month window in which existing therapies are used. The stimulation empowers stroke patients to regain use of their arm and hand, strengthening muscle activity without imposing unintended movements, the release adds.
With the FDA Breakthrough Device status, the company intends to accelerate the regulatory process for its Avantis platform through close collaboration with the agency, to “make their shared goal—changing the narrative around chronic stroke—a reality”.