Synchron's Stentrode is a fully-implantable brain-computer interface being designed to enable people with paralysis to restore functional independence by engaging in activities of daily living
Synchron Inc., a neurovascular bioelectronic medicine company, today announced that the Company has been awarded nearly AUD$1M ($990,000) in funding from the Medical Research Future Fund (MRFF), through MTPConnect, the Australian Government’s BioMedTech Horizons (BMTH) program, to advance the commercialization of Synchron’s Stentrode®. This award complements a recent AUD$1.5M National Health and Medical Research Council (NHMRC) grant received by Synchron’s collaboration partner, the University of Melbourne, to expand the current clinical study of the Stentrode®. Stentrode is a minimally-invasive brain-computer interface being designed to restore functional independence, including the ability to text message, for people with paralysis by facilitating control of external personal devices through thought alone, and without the need for open brain surgery.
"We are excited to be able to progress the development of the first fully-implantable commercial brain computer interface," said Thomas Oxley, MD, PhD, CEO of Synchron. "This support from the Australian government will accelerate the delivery of this new therapeutic paradigm to patients with this devastating and irreversible condition."
In announcing this award, the office of the Honorable Greg Hunt, MP, Minister for Health, Australia recognized the Stentrode as among the "very promising projects [that] will receive funding to help unlock some of the key health challenges of our times." Funds from this grant will be used to progress, amongst other endeavors, the software platform.
The safety and efficacy of this technology is currently being evaluated in a clinical trial. Data from participants in this trial will be used to finalize the protocol for a pivotal FDA 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.
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.