Neuralink, the brain implant development company of Ilon Musk, has approached a major U.S. neurosurgical center as a potential clinical trial partner, preparing to test its devices on humans as soon as regulators allow it, according to six people familiar with the matter.
Neuralink has been developing brain implants since 2016, which it hopes will eventually become a cure for hard-to-treat conditions such as paralysis and blindness.
The company was defeated in early 2022 when the U.S. Food and Drug Administration rejected its application for human trials, citing serious safety concerns, Reuters reported earlier this month.
The company has since been working to address the agency's concerns, but it remains to be seen if and when it will succeed.
Neuralink is in talks with the Barrow Neurological Institute, a Phoenix, Arizona-based neurological disease treatment and research organization, to help conduct human trials, sources said.
Those talks may not lead to a joint effort. Neuralink has also discussed the possibility of partnerships with other centers, added the sources, who requested anonymity to discuss the confidentiality of the discussions.
Reuters could not verify the latest status of the talks. Neuralink representatives did not respond to requests for comment.
Francisco Ponce, director of Barrow's Neuromodulation and Neurosurgical Residency Center, declined to comment on Neuralink, but said Barrow is well positioned to do such implant research because of its long history in the field.
The FDA declined to comment on Neuralink's efforts to find a partner to conduct clinical trials.
Neuralink's latest effort comes at a time when the company is facing two high-profile U.S. federal investigations into its operations.
The U.S. Department of Agriculture's inspector general began investigating potential animal welfare violations at Neuralink last year. Current and former employees detailed to Reuters that the company was hastily conducting experiments on animals, resulting in unnecessary suffering and deaths.
The U.S. Department of Transportation said it was investigating possible mishandling of dangerous pathogens during the company's collaboration with the University of California, Davis from 2018 to 2020.
Pons said Barrow helped standardize brain implant surgeries in which the patient can remain asleep, a key step in making them more acceptable to the general population.
This is in line with Musk's vision for the Neuralink brain chip. The billionaire CEO of Tesla Inc (TSLA.O) and majority owner of Twitter has said that Neuralink brain implants will become as ubiquitous as Lasik surgery for the eyes.
The devices Barrow has implanted so far are different from Neuralink devices. Barrow works with deep brain stimulation devices, which were approved by the FDA in 1997 to reduce tremor in Parkinson's disease and have been implanted in more than 175,000 patients.
Neuralink's implant is a brain-computer interface (BCI) device that uses electrodes that penetrate the brain or are located on its surface to provide direct communication with computers. So far, no company in the U.S. has received approval to bring the BCI implant to market.