The Stentrode brain-computer interface, implanted via procedures commonly used for neurovascular stent implantation, is designed to self-expand and grow into the blood vessels wall without obstructing blood flow.
Synchron Inc., which develops a so-called brain-computer interface and competes with Elon Musk’s Neuralink Corp., enrolled the first patient in its U.S. clinical trial, putting the company’s implant on a path toward possible regulatory approval for wider use in people with paralysis.
The early feasibility study is funded by the National Institutes of Health and will evaluate the safety of the device, known as the Stentrode, the New York-based company said. It will also assess how effective the Stentrode is in helping patients control digital devices hands-free.
The trial represents a landmark for Synchron, the first startup working on brain-machine interfaces to begin a clinical trial seeking approval to sell its product. It also puts Synchron ahead of Neuralink, which is better funded but is still recruiting a trial director. Neuralink raised $205 million last year. Synchron has raised $70 million total.
Brain-computer interfaces, or BCI, could empower millions of disabled people to more easily communicate and engage in modern life. Paralysis affects more than 5 million people in the U.S. alone, according to researchers at the Centers for Disease Control. Farther in the future, Musk and other technologists talk of a world where anyone could receive implants to achieve a sort of superintelligence.
Synchron’s device, once implanted, travels to the brain through blood vessels. (Neuralink’s is implanted directly into the skull.) After it reaches the brain, the Stentrode translates brain activity into signals designed to allow texting, emailing, online shopping or other activities using an external device, Synchron said.
In the past, other BCIs have received regulatory approval to treat patients on a temporary basis. Synchron’s trial, if successful, would secure approval from the U.S. Food and Drug Administration for long-term use, not just for experiments like those in a lab.
The Synchron study will eventually involve six U.S. patients, split between New York and Pittsburgh. The first patient enrolled this week at Mt. Sinai Hospital in New York. Tom Oxley, Synchron’s founder and chief executive officer, declined to identify the patient or provide demographic details.
The next step on the path toward approval would be a wider trial to test for efficacy. If the trials succeed, it will likely be several years before the Stentrode is available for sale.