The study will evaluate the long-term use of Connexus BCI for its ability to safely restore speech and enable computer control for people with severe motor impairment.

Paradromics Inc., a neurotechnology company developing the highest data-rate brain-computer interface (BCI) platform, today 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

“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.

The Connect-One Study is the first in a series of clinical applications planned for the Paradromics BCI platform. Those interested in participating in this or future studies are encouraged to join the Paradromics Community.

About the Connexus Brain-Computer Interface

The Connexus BCI is the first product built on the Paradromics BCI platform. The micro-electrodes of the Connexus brain interface, each thinner than a human hair, capture brain activity from individual neurons. The implants are made from materials that are widely trusted in medical implants for their safety and compatibility with the human body, such as titanium and platinum-iridium, helping to ensure long-term, continuous use. Signals detected by the micro-electrodes travel from the brain to a compact receiver implanted in the chest, which then wirelessly transmits the data through the skin. The information is processed by an external computer with advanced artificial intelligence to support the translation of the user's brain activity into intended speech or computer control.

About Paradromics

Paradromics builds brain-computer interface (BCI) technologies for seamless human-technology integration, to restore and enhance human capabilities. Advanced neurotechnology captures brain activity at the highest resolution—individual neurons—enabling AI-powered treatments for motor impairment now and chronic pain, addiction, depression, and other neurological conditions in the near future. The company’s first clinical product, Connexus^® BCI, is designed to restore speech and computer control for people with debilitating motor conditions. Over time, the same high-data rate interface can enable direct neural interaction with intelligent systems, immersive digital environments, and advanced prosthetics. For more information, visit www.paradromics.com or contact media@paradromics.com.

The devices used in this study are only available for investigational use, and are not for sale in any country.

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