Paradromics Inc., a neurotechnology company developing the highest data-rate brain-computer interface (BCI) platform, announced the US FDA has granted Investigational Device Exemption (IDE) approval to begin the Connect-One Early Feasibility Study (EFS) with the Connexus BCI. As the first company to receive IDE approval for speech restoration with a fully implantable BCI, Paradromics is excited to give participants the opportunity to control a computer and communicate via text or synthesized speech to recover connection.
The Connexus BCI is designed to record and decode brain signals at unprecedented rates of information transfer. “In Q1 next year we are launching a clinical study with the best engineered brain computer interface in the world,” said Paradromics’ CEO and founder, Matt Angle, Ph.D. “This is the device that patients deserve.“
The Connect-One Study will initially enroll two participants with impaired speech and limited extremity movement (upper and lower) due to severe loss of voluntary motor control who live within four hours of three clinical sites:
- UC Davis in Sacramento, CA – 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, MA – 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, MI – led by Investigator Matthew Willsey, M.D., Ph.D., a neurosurgeon with dual faculty appointments in Neurosurgery and Biomedical Engineering
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“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 the Chair of Neurosurgery at the Palo Alto Medical Foundation and holds adjunct professorships in Electrical Engineering and Neurosurgery at Stanford University.
This IDE approval builds on key 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 demonstrating that the Connexus BCI delivers an industry-leading 200+ bits per second rate of information transfer in pre-clinical models. Paradromics has a Connect-One Study roadmap to add more sites, include more participants, and explore new BCI applications.
Source: Paradromics