Synchron, the endovascular brain-computer interface (BCI) company developing technology to restore functionality in patients with severe paralysis, announced the COMMAND trial is commencing at Gates Vascular Institute, a Kaleida Health facility in Buffalo, N.Y. and teaching affiliate of the Jacobs School of Medicine and Biomedical Sciences at the University at Buffalo (UB).
The COMMAND trial is an early feasibility study (EFS) that will primarily assess safety while beginning to explore quantified efficacy measures of Synchron Switch, a brain-computer interface device implanted through the blood vessels that allows people with no or limited mobility to operate technology such as mobile devices and computers using their thoughts.
The Jacobs Institute, a nonprofit medical device innovation center who partners closely with Synchron and Kaleida Health, will mark the occasion with a roundtable discussion on March 21st targeted at physicians and clinical staff who treat diseases that cause paralysis. The discussion will feature Dr. Tom Oxley, CEO and Founder of Synchron, along with Dr. Adnan Siddiqui, CEO of the Jacobs Institute, Don Boyd, President & CEO of Kaleida Health, and Dr. Elad Levy, Principal Investigator & L. Nelson Hopkins III MD Chair of Neurosurgery, Chairman, Department of Neurosurgery, Jacobs School of Medicine & Biomedical Sciences, UB.
The COMMAND trial is being conducted under the first investigational device exemption (IDE) awarded by the FDA to a company assessing a permanently implanted BCI. The new site at Gates Vascular Institute marks the third approved COMMAND trial location, joining Mount Sinai Health System in New York and the University of Pittsburgh Medical Center. The study will assess the impact of the Synchron Switch on daily tasks such as texting, emailing, online shopping and telehealth services in a new group of eligible patients.
“Marks an important milestone in our mission to advance technology access for the millions of people who have lost the ability to use digital devices,” said Tom Oxley, MD, PhD, CEO & Founder, Synchron. “We are excited to expand the COMMAND trial with enrollment at Gates Vascular Institute as we look to advance a scalable BCI solution to the Western New York region and beyond.”
SOURCE: Businesswire