AUSTIN, Texas — Paradromics Inc., a neurotechnology company developing brain-computer interfaces (BCIs), has received approval from the U.S. Food and Drug Administration (FDA) to expand recruitment nationwide for its Connect-One Early Feasibility Study, which is evaluating an implantable device designed to restore communication in people with severe motor impairments.
The FDA-approved protocol amendment eliminates a previous requirement that prospective participants live within a four-hour drive of a participating clinical site, allowing eligible individuals from across the United States to be considered for the study.
The Connect-One study is evaluating Paradromics’ Connexus BCI, a fully implantable, wireless device that records activity from individual neurons and converts intended speech into digital communication.
Paradromics began human clinical trials of Connexus earlier this year, completing its first long-term human implantation at University of Michigan Health in June 2026. According to the company, the first participant is now using the technology to communicate independently through synthesized speech, send text messages and make phone calls.
Under the revised study protocol, participants must still be able to travel to a participating clinical site for required evaluations and follow-up visits. Those receiving primary care elsewhere must also agree to provide their primary-care clinician’s contact information to facilitate coordination of care. All other eligibility requirements remain unchanged.
The study involves three major U.S. academic medical centers: UC Davis Health in Sacramento, California, led by principal investigator David M. Brandman, MD, PhD; Mass General Brigham in Boston, led by Daniel B. Rubin, MD, PhD; and University of Michigan Health in Ann Arbor, Michigan, led by Matthew Willsey, MD, PhD.
“Being able to recruit from anywhere in the continental U.S. is an important step in the field of brain-computer interfaces. I’m excited to be able to find the right therapies for the right people who need them, no matter where they live,” Brandman said.
Paradromics is working with clinical investigators to establish procedures for supporting participants who travel significant distances, including arrangements for screening, study visits, long-term follow-up and coordination with local healthcare providers.
“We look forward to working closely with our investigators and the Institutional Review Boards at each clinical site over the coming months to establish protocols for participants traveling from greater distances. Our priority is to expand access while maintaining the highest standards of patient safety and continuity of care,” said William J. Marks Jr., MD, MS-HCM, chief clinical officer of Paradromics.
The Connect-One study received FDA authorization under an Investigational Device Exemption in November 2025. It is designed to assess the long-term safety and performance of the Connexus system in individuals with severe motor impairment.
While the initial clinical focus is restoring communication capabilities, the research is also intended to establish clinical procedures and long-term care practices necessary to support the broader use of intracortical brain-computer interfaces.
Paradromics said the expanded recruitment criteria represent another step toward developing the clinical evidence, patient support systems and healthcare infrastructure needed to make advanced BCI technology available to more people.
Participation in the study remains subject to a comprehensive clinical evaluation and determination of eligibility by the research team.
