Paradromics Receives FDA Approval to Expand Connexus® Brain-Computer Interface Clinical Study Recruitment Nationwide

Updated protocol removes four-hour geographic restriction and opens a path to broader participation through three U.S. academic medical centers

AUSTIN, Texas--(BUSINESS WIRE)--Paradromics Inc., a neurotechnology company developing high-data-rate brain-computer interfaces to restore and enhance human capabilities, today announced that the U.S. Food and Drug Administration (FDA) has approved an amendment to the protocol for its Connect-One Early Feasibility Study, removing the requirement that prospective participants live within a four-hour drive of a participating clinical site.

Connexus^® BCI is a fully implantable, wireless brain-computer interface that records activity from individual neurons and translates intended speech into digital communication. Paradromics began human clinical trials of Connexus this year, completing its first long-term human implantation at University of Michigan Health in June 2026. Its first participant is now using the BCI to communicate independently through synthesized speech, send text messages, and make phone calls.

The authorization enables eligible individuals from across the United States to be considered for participation regardless of where they reside. Under the revised protocol, participants must be able to travel to a study clinical site for required study activities, and individuals who receive primary care elsewhere must be willing to confirm their primary-care clinician’s contact information to facilitate applicable coordination of care. All other eligibility requirements remain in effect.

The Connect-One study brings together three leading U.S. academic medical centers with expertise in neurosurgery, neurological disorders, and brain-computer interface research. Participating clinical sites include UC Davis Health in Sacramento, California, with David M. Brandman, MD, PhD, lead principal investigator for the study; Mass General Brigham, in Boston, Massachusetts, with Daniel B. Rubin, MD, PhD; and University of Michigan Health in Ann Arbor, Michigan, with Matthew Willsey, MD, PhD.

Said David Brandman, MD, PhD, principal investigator for the Connect-One study at UC Davis Health, “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.”

Paradromics is working with investigators to determine how participants traveling significant distances can be appropriately supported during screening, study visits, long-term follow-up, and coordination with local clinical teams.

Said William J. Marks, Jr., MD, MS-HCM, Chief Clinical Officer of Paradromics, “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.”

Authorized under an FDA Investigational Device Exemption in November 2025, Connect-One is evaluating the long-term safety and performance of Connexus in people with severe motor impairment. Its initial clinical focus is restoring communication, while the study is also helping establish the clinical practices and long-term care procedures needed to support intracortical BCIs.

By expanding the population that may be considered for Connect-One, Paradromics and its clinical partners are taking another step toward establishing the evidence, clinical practices, and patient support systems needed to make high-performance BCI technology accessible to more people.

Individuals interested in Connect-One can learn more about the study and submit information for screening through Paradromics. Study participation is determined by the clinical research team based on the full eligibility criteria and required clinical evaluation. For more information, visit https://paradromics.com/clinical-study/.

About Paradromics

Paradromics is the high-performance BCI platform company combining frontier neural engineering with clinical discipline to move brain-computer interfaces from restoring human function to advancing human possibility. Its Connexus^® BCI is a fully implantable, permanent, high-data-rate intracortical interface that captures neural activity at individual-neuron resolution and translates intent into speech, digital control, and movement. Built for performance, safety, and durability, Connexus uses medical-grade materials and established neurosurgical workflows to support long-term neural recording and increasingly advanced applications, including robotics, sensory feedback, neurotherapeutics, and direct AI integration. Paradromics envisions a future where human intent defines the next stage of human evolution, enabled by brain-computer interfaces that extend human intelligence through AI and advanced computing. For more information, visit paradromics.com.

Caution: Connexus^® BCI is an investigational device limited by United States law to investigational use. Connexus^® and Paradromics™ are trademarks or registered trademarks of Paradromics Inc. All other trademarks are the property of their respective owners.