Austin, Texas — Paradromics Inc. announced the completion of the first surgical implantation in the FDA-approved Connect-One Early Feasibility Study at University of Michigan Health.
The study will evaluate the long-term use of the company’s Connexus brain-computer interface, or BCI, to safely restore speech and enable computer control for people with severe motor impairment.
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.
Paradromics said the Connexus BCI is designed to record, decode and translate neural signals through an implantable high-density microelectrode array. The device gathers data from the brain and sends it to a discreet transceiver in the chest, where the data is transmitted wirelessly through the skin to an external receiver.
Following FDA approval of an Investigational Device Exemption 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 because of motor neuron disease, was enrolled and implanted by Paradromics, the University of Michigan and Willsey. She 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 University of Michigan Health in 2025 as part of epilepsy research led by Willsey and his team. Paradromics said that work confirmed 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.
