AUSTIN, Texas — Paradromics Inc., a neurotechnology company advancing a high–data-rate brain-computer interface platform, has received Investigational Device Exemption approval from the U.S. Food and Drug Administration to begin the Connect-One Early Feasibility Study of its fully implantable Connexus BCI. The clinical study will evaluate the long-term use of the system to restore speech and enable computer control for people with severe motor impairment.
As the first company to secure IDE approval for speech restoration using a fully implantable BCI, Paradromics plans to give participants the ability to communicate through text or synthesized speech and to control a computer directly. The Connexus BCI is engineered to record and decode brain signals at exceptionally high information-transfer rates.
“In Q1 next year we are launching a clinical study with the best engineered brain computer interface in the world,” said Matt Angle, Ph.D., Paradromics’ CEO and founder. “This is the device that patients deserve.”
The Connect-One Study will initially enroll two participants who have impaired speech and limited upper and lower extremity movement due to severe loss of voluntary motor control. Participants must live within four hours of one of the three clinical sites:
UC Davis in Sacramento, California, led by Principal Investigator David Brandman, M.D., Ph.D., a neurosurgeon and Associate Professor in the Department of Neurological Surgery;
Massachusetts General Hospital in Boston, Massachusetts, led by Investigator Daniel Rubin, M.D., Ph.D., a critical care neurologist at Mass General Brigham and an Assistant Professor of Neurology at Harvard Medical School;
University of Michigan in Ann Arbor, Michigan, led by Investigator Matthew Willsey, M.D., Ph.D., a neurosurgeon with dual faculty appointments in Neurosurgery and Biomedical Engineering.
“The Connect-One Study marks a new peak for neurotech development, building on a decades-long foundation of rigorous academic studies using research-grade BCI technology,” said Stephen Ryu, M.D., Paradromics’ Chief Medical Officer. “Our first human trial will allow us to demonstrate the unmatched performance, safety, and reliability of our high-bandwidth BCI to help overcome human limitations.” Dr. Ryu, a board-certified neurosurgeon, is Chair of Neurosurgery at the Palo Alto Medical Foundation and holds adjunct professorships in Electrical Engineering and Neurosurgery at Stanford University.
The IDE approval follows several important milestones for Paradromics, including three years of stable preclinical recordings, the first successful acute Connexus BCI implantation at the University of Michigan by Dr. Willsey, and the release of a scientific preprint showing the Connexus system can deliver more than 200 bits per second of information transfer in preclinical testing. The Connect-One roadmap includes adding more sites, enrolling additional participants, and expanding into new BCI applications.
The Connect-One Study is the first step in a broader clinical program for the Paradromics BCI platform. Individuals interested in future participation may join the Paradromics Community.
