Musk expects brain chip start-up Neuralink to implant 'first case' this year

Billionaire entrepreneur Elon Musk expects his brain-chip startup Neuralink to start its first human trial this year, he said on Friday in France.

Co-founder Musk revealed Neuralink intends to implant a tetraplegic or paraplegic patient on a webcast while speaking at the VivaTech conference in Paris.   Musk, who is also CEO of electric vehicle manufacturer Tesla, social networking platform Twitter, and rocket launch firm SpaceX, did not say how many patients or for how long his business would implant the devices, but he did state that "it's looking like the first case will be later this year."

Neuralink announced last month that the FDA had approved its first-in-human clinical trial, a significant step for the business as it deals with American inquiries into how it handled animal experimentation. The FDA recognized in a previous statement that Neuralink was permitted to conduct trials using its brain implant and surgical robot, but it chose not to offer further information.

The FDA's approval of Neuralink's first-in-human clinical trial is an important milestone for the company as it responds to American questions into how it handled animal experiments.  Neuralink made the announcement last month. In an earlier statement, the FDA acknowledged that Neuralink was authorized to undertake trials with its brain implant and surgical robot, but it declined to provide any other details. Musk has missed timelines on his public pronouncements about Neuralink before, however.  On at least four occasions since 2019, Musk predicted that Neuralink would soon start human trials.

The company, founded in 2016, first sought permission from the FDA in early 2022, and the agency rejected the application, citing dozens of safety concerns. Some of the issues involved the lithium battery of the device, the possibility of the implant's wires migrating within the brain, and the challenge of safely extracting the device without damaging brain tissue. Neuralink also faces federal scrutiny following reports about its animal experiments.

Last year, Neuralink employees said the company was rushing and botching surgeries on monkeys, pigs and sheep, resulting in more animal deaths than necessary, as Musk pressured staff to receive FDA approval. The animal experiments produced data intended to support the company’s application for human trials, the sources said. On the time in 2021, the business inserted the incorrect-sized implants in 25 out of 60 pigs. Employees claimed that with proper planning, the mistake might have been easily avoided before the pigs were all killed.

In May, U.S. lawmakers urged regulators to investigate whether the makeup of Neuralink’s panel overseeing animal testing contributed to botched and rushed experiments after reports on potential financial conflicts on the board.The Department of Transportation is separately probing whether Neuralink illegally transported dangerous pathogens on chips removed from monkey brains without proper containment measures. An agency spokesperson said on Friday the investigation is ongoing.

Neuralink has also been under investigation by the U.S. Department of Agriculture’s Office of Inspector General for potential animal-welfare violations. This probe has been looking at the USDA’s oversight of Neuralink. An agency spokesperson didn’t immediately respond to a comment request. Employees of Neuralink who served on the organization's animal board, which has drawn government attention due to potential financial conflicts of interest, stood to gain from the implant's rapid growth.  Based on the secondary trades, the value of the Neuralink stock that some of the employees own has increased by almost 150% in just two years.