Reach Neuro Earns Breakthrough Nod for Post-Stroke Movement Restoration System

Reach Neuro, a neurotechnology company aiming to restore control and independence for patients with debilitating neurological disorders, has been granted Breakthrough Device designation from the U.S. Food and Drug Administration (FDA) for its Avantis platform.
 
Avantis delivers small electrical impulses to the spinal cord to help restore shoulder, arm, and hand movement to patients with impairment due to chronic stroke. The breakthrough status aims to address the unmet need for the nearly 7.5 million Americans living with post-stroke disability, according to the company.
 
Reach Neuro was founded in 2021 as a spinout of the University of Pittsburgh and Carnegie Mellon University—where the tech is currently being tested in an NIH-funded clinical trial in partnership with the University of Pittsburgh Medical Center (UPMC). The company is an alumni of SOSV’s IndieBio startup development program, which mentors, scales, and invests in early-stage life sciences startups.
 
A study was recently published in Nature Medicine that described results from the first two study participants.
 
“We are excited about the FDA’s recognition of our technology’s potential to change the lives of millions of people living with disability,” Marc Powell, Ph.D., CEO and co-founder of Reach Neuro told the press. “The Breakthrough Device designation is an incredible opportunity to work closely with FDA experts to expedite the clinical translation of the Avantis system.”
 
The results showed 40% and 108% improvements in grip strength respectively, and up to 124% improvement in joint strength. The improvements helped the subjects perform reaching movements 30-40% more quickly and smoothly than without stimulation—participants could also lift objects, eat with a fork, and open a lock.
 
The researchers even saw that some improvements were kept up to a month after the study, even without stimulation. The company noted, however, patients will likely benefit from having the implant long-term. Early evidence also demonstrates the Avantis system can be effective up to nine years in chronic stroke patients after their stroke, well outside the six-month window that current therapies are used.
 
Heather Rendulic, the first participant in the university-lead clinical study described 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!”