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.
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.