Reach Neuro's Avantis device delivers small
electrical impulses to the spinal cord to help stroke survivors regain
motion and independence
PITTSBURGH, April 10, 2023 /PRNewswire/ -- Reach Neuro, Inc.,
a neurotechnology company giving control and independence back to
people with debilitating neurological disorders, announced today that it
has been granted a Breakthrough Device designation by the U.S. Food and
Drug Administration (FDA) 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 Breakthrough Device 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.
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. Today, there is no standard of care for these individuals—many
of whom struggle to obtain insurance coverage for post-acute physical or
occupational therapy due to a lack of evidence that such therapy
provides benefit after the first 3-6 months post-stroke. Reach Neuro's
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.
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."
Current treatments for stroke focus only on the acute phase of
recovery and approximately 50% of stroke survivors are left with
disabilities that are considered permanent. However, early evidence
shows that the Avantis system can be effective in chronic stroke
patients even up to 9 years after their stroke, which is well outside
the 6 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.
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!"
Reach Neuro is an alumni of SOSV's IndieBio
startup development program, which mentors, scales, and invests in
early-stage life sciences startups building the future of planetary and
human health. 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.
About Reach Neuro
Reach Neuro develops implantable neuromodulation systems to
restore upper limb motor function in people with chronic stroke and
other neurological disorders. It was founded in 2021 based on work
started at the University of Pittsburgh and Carnegie Mellon University
with the goal of bringing advanced neurotechnologies out of the lab and
into the hands of patients. Its mission is to change the way we look at
physical rehabilitation and end the notion of permanent disability. For
more information, visit: www.reachneuro.com.
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