Avantis platform uses small electrical impulses and delivers them to the spinal cord to help restore arm, shoulder, and hand movement in patients with impairment caused by chronic stroke
Avantis platform gets FDA breakthrough status. (Credit: Tom Claes on Unsplash)
Neurotechnology company Reach Neuro has received breakthrough device designation from the US Food and Drug Administration (FDA) for its Avantis platform to restore movements.
The Avantis platform delivers small electrical impulses to the spinal cord. This approach is expected to help restore arm, shoulder, and hand movement in patients with impairment caused by chronic stroke.
According to the Pittsburgh-based Reach Neuro, the platform directly restores the ability of patients to control movement. This gives quick relief and supports patients to return to therapy and make further improvements.
As per early evidence, the system demonstrated effectiveness in chronic stroke patients even up to nine years after the stroke. It enables them to strengthen muscle activity without imposing unwanted movements and regains the use of their arm and hand.
Reach Neuro CEO and co-founder Marc Powell said: “We are excited about the FDA’s recognition of our technology’s potential to change the lives of millions of people living with disability.
“The Breakthrough Device designation is an incredible opportunity to work closely with FDA experts to expedite the clinical translation of the Avantis system.”
The neurotechnology company, which is a spinout from the University of Pittsburgh and Carnegie Mellon University, is currently testing the technology in a National Institutes of Health (NIH)-funded clinical trial in partnership with the University of Pittsburgh Medical Centre (UPMC).
Recently, the research team published the results from the first two study participants. In the study, the participants showed 40% and 108% improvements in grip strength respectively along with a 124% improvement in joint strength.
Reach Neuro said that these improvements enabled the subjects to perform reaching movements more quickly without stimulation. The participants also successfully performed functional tasks like lifting objects, eating with a fork, and opening a lock.
Additionally, the researchers found that the improvements were consistent up to one month after the study, even without stimulation.
The FDA breakthrough device status will expedite the regulatory process for theAvantis platform through close collaboration with the regulator, the neurotechnology company said.