The Connect-One Early Feasibility Study will evaluate the long-term use of the Connexus BCI to safely restore speech and enable computer control for people with severe motor impairment
AUSTIN, Texas--(BUSINESS WIRE)--Paradromics Inc., a neurotechnology company that has developed the highest data-rate brain-computer interface (BCI) platform, announced today the completion of the first surgical implantation in the FDA-approved Connect-One Early Feasibility Study (EFS) at University of Michigan Health. The procedure was performed by Matthew Willsey, M.D., Ph.D., a neurosurgeon and biomedical engineer, with Aditya S. Pandey, M.D., and a multidisciplinary team of providers.
The Connexus® BCI is designed to record, decode, and translate neural signals through an implantable high-density microelectrode array that gathers data from the brain and sends it to a discrete transceiver in the chest, where it is then transmitted wirelessly through the skin to an external receiver. The study will evaluate the long-term use of the Connexus BCI for its ability to safely restore speech and enable computer control for people living with severe motor impairment.
Following FDA approval of an Investigational Device Exemption (IDE) in November 2025, clinical teams at the University of Michigan, UC Davis, and Massachusetts General Hospital began screening eligible participants. The first participant, a Michigan woman who has difficulty speaking due to motor neuron disease, was enrolled and implanted by Paradromics, the University of Michigan, and Dr. Willsey, and will be followed and evaluated over the next six years.
“This implant marks a major milestone for Paradromics and for the future of high-performance brain-computer interfaces,” said Matt Angle, Ph.D., CEO and founder of Paradromics. “Our team has spent years building a device designed to restore communication in a way that reflects the speed, complexity, and individuality of human expression. For people living with severe motor impairment, the ability to communicate is central to agency, identity, and connection. We are honored to begin this clinical study with our first participant and grateful for the trust she and the clinical team have placed in us.”
“This technology offers new potential to help people who have lost their ability to communicate, and we are thrilled to help clinically translate this novel therapy with the team at Paradromics,” Willsey said.
David M. Brandman, M.D., Ph.D., Lead Principal Investigator of the Connect-One Study and Associate Professor of Neurosurgery at University of California, Davis, said, “The Connexus BCI reflects decades of progress across the intracortical BCI research community. With the Connect-One Study, we have an opportunity to evaluate that progress in a rigorous clinical setting and better understand its potential to help people regain communication.”
The implantation builds on Paradromics’ first successful temporary Connexus BCI implantation, completed at U-M Health in 2025 as part of epilepsy research led by Dr. Willsey and his team, which confirmed that the device could be safely placed into the brain and reliably record brain signals.
The Connect-One study is the first in a series of clinical applications planned for the Paradromics BCI platform.
About Paradromics
Paradromics builds brain-computer interface (BCI) technologies for seamless human-technology integration, designed to restore and enhance human capabilities. By capturing brain activity at the resolution of individual neurons, the company's high-data-rate platform creates a foundation for the most advanced BCI applications. The company's first product, the Connexus® BCI, is designed to restore speech and computer control for people with severe loss of motor control. Over time, the same platform will power direct AI interaction, advanced prosthetics, and next-generation treatments for mental health and other neurological conditions. With each new application, Paradromics will help restore essential human functions, expand human capability, and enable the fuller expression of human intelligence. For more information, visit www.paradromics.com or contact media@paradromics.com.
Disclaimer: Connexus® BCI is an investigational device limited by United States law to investigational use.
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