Paradromics Secures FDA Approval for Innovative Brain-Computer Interface Study

Paradromics Inc., a leader in neurotechnology focused on developing high data-rate brain-computer interface (BCI) platforms, has announced that the US FDA has granted Investigational Device Exemption (IDE) approval for the Connect-One Early Feasibility Study (EFS) using the Connexus BCI. As the first company to achieve IDE approval for speech restoration with a fully implantable BCI, Paradromics is thrilled to offer participants the chance to regain communication and computer control capabilities.

The Connexus BCI is engineered to record and decode brain signals with unprecedented information transfer rates. "In Q1 next year we are launching a clinical study with the best engineered brain computer interface in the world,” stated Paradromics’ CEO and founder, Matt Angle, Ph.D. “This is the device that patients deserve.“

The Connect-One Study will start with two participants who have impaired speech and limited movement in their extremities due to severe motor control loss. These participants will be recruited from locations near three clinical sites:

- UC Davis in Sacramento, CA, led by Principal Investigator David Brandman, M.D., Ph.D.
- Massachusetts General Hospital in Boston, MA, led by Investigator Daniel Rubin, M.D., Ph.D.
- University of Michigan in Ann Arbor, MI, led by Investigator Matthew Willsey, M.D., Ph.D.

“The Connect-One Study marks a new peak for neurotech development, building on a decades-long foundation of rigorous academic studies using research-grade BCI technology,” remarked Stephen Ryu, M.D., Chief Medical Officer at Paradromics. “Our first human trial will allow us to demonstrate the unmatched performance, safety, and reliability of our high-bandwidth BCI to help overcome human limitations.” Dr. Ryu, a board-certified neurosurgeon, is also the Chair of Neurosurgery at the Palo Alto Medical Foundation and holds adjunct professorships at Stanford University.

This IDE approval is a significant milestone for Paradromics, following three years of stable preclinical recordings and the successful acute Connexus BCI implantation by Dr. Willsey at the University of Michigan. The company has also released a scientific preprint showing that the Connexus BCI achieves an industry-leading rate of over 200 bits per second in pre-clinical models. Paradromics plans to expand the Connect-One Study by adding more sites and participants, as well as exploring new BCI applications.

The Connect-One Study is the first of several clinical applications planned for the Paradromics BCI platform. Individuals interested in participating in this study or future studies are encouraged to join the Paradromics Community.