ANN ARBOR, MICHIGAN — Neurosurgeons at University of Michigan Health completed the first human implant of a wireless brain-computer interface manufactured by Paradromics Inc. The procedure involved Matthew Willsey, M.D., Ph.D., and Aditya S. Pandey, M.D., implanting the Connexus brain-computer interface as part of the Connect-One Early Feasibility Study.

The implant recipient is a woman from Michigan who struggles to speak due to motor neuron disease. The Connect-One clinical trial focuses on the long-term safety of the device and assesses whether it can restore communication through synthesized text and speech, and also help users control a computer.

Willsey, a neurosurgeon and biomedical engineer, commented on the potential of the device. "We are incredibly excited to investigate the potential of this wireless BCI to restore communication for people who have lost the ability to speak due to neurological disease or injury. This has the potential to be a major step forward as we work toward our goal of helping treat people with paralysis who otherwise lack efficient and effective therapies for preserving communication," Willsey said.

Paradromics received an Investigational Device Exemption from the U.S. Food and Drug Administration in November 2025 to begin the Connect-One clinical study. The Paradromics brain-computer interface contains 421 microelectrodes designed to capture brain signals from individual neurons. These captured signals are then sent to a small transceiver located in the user's chest, which transmits information to an external receiver.

Michigan Medicine was one of three sites enrolling participants for the Connect-One study. Participants in the study will be followed for six years after the implant. The patient will continue to receive care for motor neuron disease from the Stanford Morris ALS Clinic at University of Michigan Health. Motor neuron disorders affect the function of motor neurons in the brain, brainstem, and spinal cord; amyotrophic lateral sclerosis is the most common form of these disorders.

Matt Angle, CEO and founder of Paradromics, stated the importance of this study. "Enrolling our first participant at University of Michigan is a defining moment for our company and for the field. Our goal is to restore natural communication for people who have lost the ability to speak and help them stay connected with their loved ones. We're proud to partner with University of Michigan Health on this first-in-human study as we build the foundation for the next generation of clinical BCIs," Angle said.

A temporary implant of the Connexus device was performed in June 2025 during epilepsy research. This prior procedure confirmed that the device could be safely placed into the brain and record signals. Willsey also leads a new Brain-Computer Interface Clinic that opened at Michigan Medicine in 2025, and his laboratory sponsors a separate clinical trial investigating an investigational brain-computer interface for restoring movement and communication.

Stephen Goutman, Director of the Stanford Morris ALS Clinic and Harriet Hiller Research Professor at U-M, emphasized the significance of preserving communication. "It is critical to preserve communication for all those living with motor neuron disease to keep individuals connected to their families and friends, and to preserve independence and quality of life. We are so fortunate to be able to partner with Dr. Willsey and the incredible neurosurgical team here at U-M Health as they work to bring these devices into the clinic and make motor neuron diseases more livable," Goutman said.