Synchron to Begin Patient Enrollment for the COMMAND Trial of Brain-Computer Interface at Gates Vascular Institute

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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.

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Monday, March 20, 2023
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Hardware, FDA, Health Technology, Technology, Nanotechnology, Surgery, Medical Devices, Neurology, Clinical Trials, Biotechnology, Science, Software, Other Science, Research, Health, Mobile, Wireless, Extremities, UB, Kaleida Health, University, Gates Vascular Institute, BCI, Jacobs School of Medicine and Biomedical Sciences, COMMAND, Buffalo buffalo Buffalo buffalo buffalo buffalo Buffalo buffalo, MBA, Brain, Biomedical sciences, CMO, Doctor of Philosophy, Computer, Jacobs Institute for Design Innovation, Trial of the century, Paralysis, Blood, Motor cortex, University of Pittsburgh Medical Center, Professor, MD, FAHA, Patient, Physician, SUNY, FACS, SUNY UB, EFS, IDE, Mount Sinai Health System, JAMA Neurology, Safety, Medical imaging, Medical device, Management, Medicine, Beckman Coulter, Neurosurgery
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NEW YORK, UNITED STATES, NORTH AMERICA, AUSTRALIA, NEW YORK CITY
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SYNCHRON, GATES VASCULAR INSTITUTE
Summary
Key Points: 
  • 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 FDA granted Breakthrough Device designation to Synchron in August 2020 and an IDE in July 2021.
  • There is no guarantee of participation and principal investigators make the final determination of patient eligibility.


Synchron, the endovascular brain-computer interface (BCI) company developing technology to restore functionality in patients with severe paralysis, today 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.

The FDA granted Breakthrough Device designation to Synchron in August 2020 and an IDE in July 2021.

“Today 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.”

“It is humbling to be a part of breakthrough brain computer interface technology that can reconnect people with their loved ones and the outside world. We are fortunate to be able to bring this remarkable technology to our patients in western New York,” said Elad Levy, MD, MBA, Principal Investigator & L. Nelson Hopkins III MD Chair of Neurosurgery, Chairman, Department of Neurosurgery, Jacobs School of Medicine & Biomedical Sciences, UB.

“We are delighted to participate in this clinical study evaluating a first of its kind endovascular technology that allows people who have lost the ability to use their extremities to start regaining functionality. We believe this is simply the first step in a whole new clinical field of neuroendovascular electrophysiology,” said Adnan H. Siddiqui, MD, PhD, FACS, FAHA, CEO & CMO, Jacobs Institute, Professor & Vice Chairman, Director Neuroendovascular Fellowship & Research, Department of Neurosurgery, Director Canon Stroke and Vascular Research Center, SUNY UB.

The Synchron Switch™ brain computer interface is implanted in the blood vessel on the surface of the motor cortex of the brain via the jugular vein, through a minimally-invasive endovascular procedure. Once implanted, it is designed to detect and wirelessly transmit motor intent out of the brain, restoring the capability for severely paralyzed patients to control personal devices with hands-free point-and-click. Synchron recently published long-term safety results from its SWITCH study in Australia in JAMA Neurology.

COMMAND trial sites in New York City, Buffalo and Pittsburgh are recruiting patients. Referring physicians may obtain trial details and study coordinator contact information at https://clinicaltrials.gov/ct2/show/NCT05035823. There is no guarantee of participation and principal investigators make the final determination of patient eligibility.

About Gates Vascular Institute

Buffalo General Medical Center/Gates Vascular Institute is the largest Kaleida Health facility and a major teaching affiliate of the Jacobs School of Medicine and Biomedical Sciences at the University at Buffalo. As a 484-bed acute care medical center located on the Buffalo Niagara Medical Campus in downtown Buffalo, NY, Buffalo General Medical Center/Gates Vascular Institute provides a wide spectrum of clinical inpatient and outpatient services, along with specialized medical and surgical programs, comprehensive vascular care, revolutionary neurological procedures and cardiac services unavailable anywhere else in the region.

About Synchron

Synchron is a clinical-stage endovascular brain computer interface (BCI) company. Since 2012, the company has been developing a BCI platform that avoids the need for open brain surgery by using a minimally-invasive procedure. The Synchron Switch™ BCI received FDA Breakthrough Device Designation in 2020, and the company is currently conducting a human clinical trial in the US. Synchron’s research has been published in multiple peer-reviewed journals including JAMA Neurology, Nature Biotechnology, Nature Biomedical Engineering and JNIS. Synchron is based in Brooklyn, New York with R&D facilities in Melbourne, Australia. For more information, visit www.synchron.com. Follow us on Twitter @synchroninc.

About the Jacobs Institute

The Jacobs Institute is a non-profit medical device innovation center whose mission is to accelerate the development of next-generation technologies in vascular medicine through collisions of physicians, engineers, entrepreneurs, and industry. The JI’s vision is to improve the treatment of vascular disease in Western New York and the world, while fostering local economic development. The JI fosters medical collaboration and innovation through partnerships with the University at Buffalo (UB), Kaleida Health, and industry, to be a fitting tribute to the work and memory of Lawrence D. Jacobs, M.D. To learn more about the Jacobs Institute, please visit our web site at: www.jacobsinstitute.org.

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