NEW YORK--(BUSINESS WIRE)--Synchron, the leading endovascular brain-computer interface (BCI) company developing technology to restore functionality in patients with severe paralysis, today announced enrollment in the COMMAND trial has commenced at the University of Pittsburgh (the “University”), Pittsburgh, PA.
The COMMAND trial is an early feasibility study (EFS) funded by the National Institutes of Health (NIH), and will primarily assess safety while beginning to explore quantified efficacy measures of Synchron’s Stentrode™ in patients with severe paralysis with the goal of enabling the patient to control digital devices, hands-free.
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. This new site at the University marks the second approved COMMAND trial location, joining Mount Sinai in New York.
“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 the University as we look to advance a scalable BCI solution to market.”
The Stentrode is implanted within the motor cortex of the brain via the jugular vein in a minimally-invasive endovascular procedure. Once implanted, it detects and wirelessly transmits motor intent, restoring a capability for severely paralyzed patients to control personal devices with hands-free point-and-click. The trial will assess the impact of tasks such as texting, emailing, online shopping, and telehealth services. The FDA granted Breakthrough Device designation to Synchron in August 2020 and an IDE in July 2021.
“Synchron’s Stentrode has the potential to restore functionality to the millions of people worldwide suffering from paralysis,” said Raul Nogueira, MD, FAHA, FSIN, Endowed Professor & Division Chief of Cerebrovascular Medicine, Director, UPMC Stroke Institute, Professor of Neurology & Neurosurgery at the University of Pittsburgh. “Giving patients the option to receive this device without the need for open brain surgery, may open endless possibilities into the application and scalability of this promising technology.”
“This exciting technology may open up the possibility for patients with paralysis to use digital devices to communicate with loved ones again, and restore independence back into their lives,” said David Lacomis, MD, principal investigator and Chief of Neuromuscular Division at the University of Pittsburgh. “Something as simple as surfing the web or doing online grocery shopping can seem mundane to some, but it can change the world for someone who previously had those fundamental abilities taken away.”
COMMAND trial sites in New York, NY and Pittsburgh, PA are recruiting patients. Referring physicians may direct their inquiries to COMMAND@synchron.com to be put in touch with a study coordinator. There is no guarantee of participation and principal investigators make the final determination of patient eligibility.
About the Stentrode™
Synchron’s flagship technology, the Stentrode, is an endovascular brain implant designed to enable patients to wirelessly control digital devices through thought and improve functional independence. Synchron’s foundational technology, a motor neuroprosthesis (MNP), or motor BCI, is implanted via the jugular vein using neurointerventional techniques commonly used to treat stroke, and does not require drilling into the skull or open brain surgery. The system is designed for patients suffering from paralysis as a result of a broad range of conditions, and aims to be user friendly and dependable for patients to use autonomously.
About Synchron, Inc.
Synchron, an endovascular brain interface company, is a leader in implantable neural interface technology. The clinical-stage company is developing a neuroprosthesis for the treatment of paralysis and the first endovascular implantable neuromodulation therapy. Future applications include the potential to diagnose and treat conditions of the nervous system, including Parkinson’s disease, epilepsy, depression, and hypertension. Synchron is headquartered in New York City with R&D facilities in Melbourne, Australia. For more information, visit www.synchron.com. Follow us on Twitter @synchroninc.
About the University of Pittsburgh: Founded in 1787, the University of Pittsburgh is an internationally renowned leader in health sciences learning and research. A top 10 recipient of NIH funding since 1998, Pitt has repeatedly been ranked as the best public university in the Northeast, per The Wall Street Journal/Times Higher Education. Pitt consists of a campus in Pittsburgh—home to 16 undergraduate, graduate and professional schools — and four regional campuses located throughout Western Pennsylvania. Pitt offers nearly 500 distinct degree programs; serves more than 33,000 students; employs more than 13,000 faculty and staff; and awards 9,000 degrees systemwide.
