Synchron said today that it completed the first successful clinical implantation of the Stentrode neural interface technology designed to restore communication in people with severe paralysis.
The Campbell, Calif.-based company said the minimally invasive neural interface technology, as part of the Synchron brain-computer interface, is in its first clinical feasibility trial.
The Stentrode is an investigational, implantable device that’s delivered via cerebral angiography catheter. It is designed to record brain activity and wirelessly stream thoughts from the brain using a platform called brainOS to translate the brain activity into a standardized digital language.
Synchron also uses brainPort, a wireless solution implanted in the chest, to transmit high-resolution neural data as part of the brain-computer interface.
The company expects the trial to evaluate the safety and stability of brain signals for controlling external communications technologies. The study, which kicked off in April, is being conducted in Melbourne, Australia, with patients who have loss of motor function due to paralysis from conditions like spinal cord injury, stroke, muscular dystrophy or motor neuron disease.
Synchron said it is discussing regulatory strategy with the FDA, which has contributed to the planning for the first-in-human trial. The company added that the data from the first participates will finalize the protocol for a pivotal study that will influence evaluation for marketing approval in the U.S.
“The commencement of human trials of a commercial brain computer interface is a major milestone for the industry,” CEO Dr. Thomas Oxley said in prepared remarks. “By using veins as a naturally-existing highway into the brain, we have been able to reach the clinical stage significantly earlier than other more invasive approaches.”
“By reimagining the concept of the operating system, we have designed our technology platform to enable a completely hands-free user experience,” added Oxley. “What we learn from the first-in-human clinical trial will be highly valuable in guiding our device design and clinical protocol for a pivotal trial in the U.S. … Our bodies can only carry so much information out of the brain. This industry is going to unlock the brain’s computational power in ways that are hard to imagine now. This is just the beginning.”
