Reach Neuro’s Avantis platform receives breakthrough device designation from the FDA

The Food and Drug Administration (FDA) has awarded breakthrough status to Pittsburgh-based Reach Neuro’s Avantis platform which works to restore movement in patients that experienced partial paralysis after suffering from a stroke. 

The new designation allows Reach Neuro to form a direct communication channel with the FDA and eliminate the need for subsequent regulatory submissions. This fast pass is usually granted to new technologies aimed at treating life-threatening or irreversible conditions.

The breakthrough designation allows Reach Neuro to expedite the process of bringing the new technology to approximately 7.5 million people in the U.S. who are living with post-stroke disabilities.

Marc Powell, CEO and co-founder of Reach Neuro, said, “The breakthrough device designation is an incredible opportunity to work closely with FDA experts to expedite the clinical translation of the Avantis system.”

The Avantis Platform: Restoring Movement with Electrical Impulses

• The Avantis platform can help restore movement to the arm, shoulder, and hand
• It works by delivering small electrical impulses to the spinal cord with an implant equipped with electrodes
• The electrodes emit electrical impulses that stimulate the nervous system
• The Avantis platform is designed to restore movement in people with spinal cord injuries or other conditions that affect the nervous system

In 2021, Reach Neuro was formed out of two institutes, Carnegie Mellon University and the University of Pittsburgh. Researchers from these institutes have now published a study of the Avantis platform in the Nature Medicine journal.

The study, which enrolled two participants, was published in late February and revealed that implanting the spinal cord stimulator was able to improve the grip of the participants in the study. After being implanted with the device for 29 days, participants’ grip improved by 40% and 108%.

Moreover, their ability to reach out for objects also quickened, with average speed rising between 30% to 40%, as well as their ability to perform functional tasks, including using eating utensils, opening locks, and picking up objects. Joint strength also improved by 124%. The device successfully strengthened muscle activity without adding the stress of unintended movements.

These positive results lasted in patients even sometime after the neurostimulation implants had been removed.

This new technology provides patients with immediate relief that acts as an incentive to move to therapy, which can further improve patient prognosis. Another notable benefit of the device is that there does not appear to be a time limit on how long after a stroke the therapy can have an effect since one participant in the study experienced a stroke 9 years ago.

While the firm is currently testing the technology in an NIH-funded clinical trial and present findings are backed by the NIH’s neurotech-focused BRAIN initiative, the need for a larger trial testing the system’s efficacy and safety in treating chronic stroke patients has been highlighted. This is also to determine if there are types of patients who may particularly benefit from the treatment more than others.

Despite this, the general expectation is that Avantis will be able to pass through the regulatory process fairly quickly since it builds on already FDA-cleared spinal cord stimulation tech.

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