FDA Grants Breakthrough Device Designation to Reach Neuro’s Chronic Stroke Platform

Marc Powell, PhD

Recently, the FDA granted breakthrough device designation for Reach Neuro’s Avantis, a platform that delivers small electrical impulses to the spinal cord to restore shoulder, arm, and hand movement to post chronic stoke patients.¹

The Avantis system is built to restore a patient's ability to control movement directly, giving them not only immediate relief but also allowing it to be possible for them to return to therapy. Early evidence has shown the effectiveness of the system in patients with chronic stroke up to 9 years poststroke, outside of the 6 month window where existing therapies are typically used.

"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, PhD, CEO, Co-Founder of Reach Neuro said in a statement.¹ "The Breakthrough Device designation is an incredible opportunity to work closely with FDA experts to expedite the clinical translation of the Avantis system."

Currently, Reach Neuro is testing the technology in collaboration with the University of Pittsburgh Medical Center (UPMC) in a clinical trial (NCT04512690) funded by National Institutes of Health. Reports from the first 2 study participants, recently published in Nature Medicine reported 40% and 108% improvements in grip strength, respectively, and up to 124% improvement in joint strength, enabling them to perform reaching movements between 30% and 40% faster than without stimulation.

The patients in the study were also able to perform more independent functional tasks including lifting objects, eating with a fork, and opening a lock. Investigators observed some improvements that were retained up to 1 month poststudy without the stimulation. However, the researchers noted that the patients having the implant chronically will likely benefit them.

Heather Rendulic, the first participant in the university-lead clinical study, described her experience with the device in a statement, "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!"¹

An estimated 800,000 patients per year have a stroke in the US, and nearly half will have permanent damage to the brain's ability to send signals to muscles because of some form of long-term paralysis. Additionally, there is no current standard of care for these patients and many are challenged with insurance coverage for postacute therapy because of a lack of evidence the therapy benefits them after the first 3 to 6 months poststroke. 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.¹

With the platform's Breakthrough Device status, Reach Neuro plans to accelerate the regulatory process for Avantis with the FDA through close collaboration, with the goal of changing the narrative around chronic stroke care into a reality.

REFERENCES
1. Reach Neuro receives FDA Breakthrough Device designation for device to restore arm and hand movement to chronic stroke patients. News Release. Reach Neuro. Published April 10, 2023. Accessed April 17, 2023. https://www.prnewswire.com/news-releases/reach-neuro-receives-fda-breakthrough-device-designation-for-device-to-restore-arm-and-hand-movement-to-chronic-stroke-patients-301793333.html