Elon Musk’s brain-computer interface company Neuralink has approached one of the largest neurosurgery centers in the United States as a potential clinical trial partner, Reuters revealed, citing six people familiar with the matter. The company is prepared to test its device on human bodies if regulators allow it to do so.
On at least four occasions since 2019, Musk has predicted that his brain-machine interface company Neuralink will soon launch human trials of a revolutionary brain implant to treat difficult conditions such as paralysis and blindness.
However, earlier this month news broke that Neuralink’s application for human trials had been rejected due to safety concerns. According to seven current and former Neuralink employees, the company, which was founded in 2016, did not seek permission from the U.S. Food and Drug Administration (FDA) for human trials until early 2022, but has been denied.
Since then, the company has been working to try to unravel what the FDA was worried about, and it’s unclear if and when it will succeed. Neuralink has been in talks with the Barrow Neurological Institute, a neurological disease treatment and research facility in Phoenix, Arizona, to help conduct human trials, the sources said.
Of course, the negotiations may not result in a substantial collaboration, but the source added that Neuralink has also discussed similar collaborations with other research centers. Neuralink representatives have not yet responded to requests for comment, and the FDA declined to comment.
Francisco Ponce, director of the Center for Neuromodulation and Neurosurgery Residency Program at Barrow Hospital, declined to comment on Neuralink, but said Barrow’s long track record in the field puts it in a good position to conduct research on such implants.
Ponce said the Barrow Neurological Institute helped them standardize the brain implant procedure, ensuring that patients could remain asleep during the procedure, a key step in making it more accessible to a wide range of people.
It’s worth noting that the device Barrow implanted differs from Neuralink’s in that Barrow uses a deep brain stimulation device that was approved by the FDA in 1997 to help prevent or reduce tremors in Parkinson’s disease in humans and has been implanted in more than 175,000 patients.
The Neuralink implant, by contrast, is a brain-computer interface (BCI) device that communicates directly with a computer with the help of electrodes that penetrate the brain or are located on the surface of the brain. No company has so far been able to obtain FDA clearance to bring a BCI implant to market.