Paradromics has received FDA approval to expand nationwide recruitment for its Connect-One Early Feasibility Study, which is evaluating the company's investigational Connexus brain-computer interface (BCI). The authorization removes a previous requirement limiting participants to those living within four hours of a study site, allowing eligible individuals across the continental United States to enroll.
Connexus is a fully implantable, wireless BCI designed to help people with severe communication impairments communicate by translating speech-related brain activity into digital outputs. The system records signals from individual neurons and transmits them through an implanted interface to a receiver worn on the chest. These signals are then processed by a computer and converted into text, synthesized speech or commands for connected devices.
The Connect-One study is evaluating the safety and functionality of the technology over six years. Participants attend regular sessions to calibrate and personalize the system according to their communication needs. Clinical sites include UC Davis Health in California, Mass General Brigham in Massachusetts and University of Michigan Health. Although the geographic restriction has been removed, participants must still travel for study activities and meet the existing eligibility requirements.
Paradromics received an FDA investigational device exemption in November 2025 and completed its first long-term human implantation in June 2026. In September, the company reported that a participant with a progressive motor neuron disease had successfully used the system to select words, answer open-ended questions and communicate with her grandchildren during a phone call. These early results demonstrate the technology's potential to restore communication capabilities, although further clinical evaluation is required.
The recruitment expansion comes amid growing investment and clinical progress in brain-computer interfaces. Companies including Neuralink and Precision Neuroscience are also developing technologies that translate neural activity into communication or device-control commands. By expanding recruitment nationwide, Paradromics aims to increase access to its clinical study and gather additional evidence to support the development of its implantable communication system.
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