Synchron's Stentrode brain-computer interface system is a fully-implantable therapeutic being evaluated for its safety and efficacy to restore functional independence via hands-free control of electronic devices in patients with upper limb paralysis
SAN FRANCISCO and NEW YORK and MELBOURNE, June 25, 2020 /PRNewswire/ -- Synchron Inc., a neurovascular bioelectronic medicine company, today announced that the University of Melbourne has been awarded an AUD$1.5M Medical Research Future Fund grant from the National Health and Medical Research Council (NHMRC) of the Australian Government to expand the current clinical study of Synchron's Stentrode®. The study is the first clinical trial to evaluate the safety and efficacy of the Stentrode, the first interventional neuromodulation platform. This technology is designed to translate brain activity from the inside of a blood vessel, and is being explored for its potential to enable hands-free control of devices for people with upper limb paralysis.
"Having this support from the Australian government further validates the importance of our work and our confidence that this technology will lead to the realization of a treatment option with the capability to transform the lives of patients with paralysis," said Thomas Oxley, MD, PhD, CEO of Synchron. "The potential to advance this important work that this grant offers cannot be understated."
The funds will be used to expand the current feasibility study to include:
The safety and efficacy data from these first participants will be used to finalize the protocol for a pivotal FDA-enabling study, intended to support U.S. marketing approval. Synchron continues to engage in discussions with the FDA over its regulatory strategy, and the FDA's guidance has contributed to the planning for Synchron's first-in-human trial as a preliminary step on an approval pathway.
In December, the company announced the first successful clinical implantation of the Stentrode. Pre-clinical studies have demonstrated the Stentrode's long-term safety as well its ability to pick up specific electrical frequencies emitted by the brain. Synchron, in collaboration with the University of Melbourne, has published their preclinical results in top-ranking journals including Nature Biotechnology, Nature Biomedical Engineering and the Journal of Neurosurgery.
Similar to the procedure utilized for implantation of cardiac pacemakers, implantation of the Stentrode is a minimally-invasive procedure during which the device is delivered to the brain through blood vessels. As the Stentrode system is small and flexible enough to safely pass through curving blood vessels, insertion of the Stentrode does not require open brain surgery. Other neural interface devices, such as those being developed by Elon Musk's Neuralink and BrainGate, currently require drilling open the skull and a direct puncture into the brain to achieve device implantation.
About Stentrode
The only interventional neuromodulation platform, Stentrode™ is designed to function as both a neuroprosthesis and neuromodulation device. The tiny Stentrode motor neuroprosthesis is implanted next to the brain's motor cortex and interacts with the nervous system from inside a blood vessel to translate brain commands. The Stentrode brain-computer interface system is undergoing clinical investigation to evaluate its ability to improve functional independence for people with paralysis by restoring command control of external devices that facilitate instrumental activities of daily living. Future interventional neuromodulation applications may include the potential to diagnose and treat nervous system conditions, including Parkinson's disease, epilepsy, depression, and hypertension.
About Synchron, Inc.
Synchron, Inc. is a clinical-stage neurovascular bioelectronics medicine company developing bloodstream-enabled solutions for previously-untreatable nervous system conditions. The company is pioneering the field of interventional neuromodulation and developing the world's first motor neuroprosthesis, the Stentrode™, a brain-computer interface in clinical trials to evaluate its ability to help paralyzed patients regain the ability to communicate. The company is also developing endovascular neuromodulation solutions for the potential treatment of Parkinson's disease, epilepsy, depression and hypertension, among other disorders. Development of this technology platform was spun out of the University of Melbourne and has been funded in part through grants from the U.S. Defense Advanced Research Projects Agency (DARPA) and U.S. Department of Defense (DoD). The technology was publicly endorsed by then-President Barack Obama as 'technology that has the potential to transform lives'. Neuro Technology Investors, LLC, subsequently led the Series A round of financing, which also included METIS innovative. Headquartered in Silicon Valley, California, Synchron has a presence at Newlab in Brooklyn, New York and R&D facilities in Melbourne, Australia.