Synchron 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) programme, to advance the commercialisation of Synchron’s 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.
The award accompanies 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.
“We are excited to be able to progress the development of the first fully-implantable commercial brain computer interface,” said Thomas Oxley, 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 a recent press release, the company note that 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 finalise the protocol for a pivotal US Food and Drug Administration (FDA) study, intended to support US 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 journals including Nature Biotechnology, Nature Biomedical Engineering and the Journal of Neurosurgery.
Similar to the procedure utilised 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.