In the US, an estimated 800,000 people per year have a stroke, and nearly half will experience some form of long-term paralysis as a result of permanent damage to the brain’s ability to send signals to muscles. Reach Neuro (IBSF 13) directly restores a patient’s ability to control movement post-stroke, not only giving immediate relief, but also making it possible to return to therapy and continue making even further improvements.
The patients are on board, and now the FDA is too: today, Reach announced that it has been granted an FDA Breakthrough Device designation for its Avantis platform. Avantis 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 FDA designation recognizes the importance of bringing this technology to clinics quickly to address an enormous un-met need for the nearly 7.5 million Americans living with post-stroke disability.
Reach Neuro was founded in 2021 as a spinout company of the University of Pittsburgh and Carnegie Mellon University, where the technology is currently being tested in an 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, 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, Ph.D. CEO, 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.”
Heather Rendulic, the first participant in the university-lead clinical study describes her experience with the device: “Having the stimulation working and being able to move my arm/hand again after 9 years was one of the most surreal experiences of my life—it was as if my brain was in control of my arm again. This technology gave me such immense hope that one day I will regain a sense of independence again. This will change the lives of millions of people!”