Elon Musk anticipates that the first human trial for Neuralink’s brain chip will begin this year

A crucial step for the startup, Neuralink received US FDA approval last month for its first-in-human clinical trial.Elon Musk, a multibillionaire businessman, said on Friday in France that his brain-chip startup Neuralink plans to launch its first human trial this year.

Co-founder Musk stated during a webcast watched by Reuters that Neuralink intends to implant a patient who is paralysed or tetraplegic. He was speaking at the VivaTech conference in Paris. Elon Musk, who is also CEO of electric car manufacturer Tesla, social media platform Twitter, and rocket launch firm SpaceX, did not say how many patients or for how long his company 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 US Food and Drug Administration (FDA) had approved its first-in-human clinical trial, a significant step for the startup as it deals with US inquiries into how it handled animal experimentation. The FDA acknowledged in a prior statement to Reuters that Neuralink was permitted to conduct trials using its brain implant and surgical robot, but it chose not to provide further information.

Experts previously told Reuters that even if Neuralink can demonstrate that its product is safe for human use, it would still take a while—possibly more than a decade—for the start-up to obtain commercial use clearance. Other neurotech firms that have already implanted their devices in people are in competition with the company.

Elon Musk has previously missed deadlines for his public statements about Neuralink, though. Since 2019, Musk has predicted that Neuralink will soon begin human trials at least four times.

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According to Reuters, the company, which was 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 concerns concerned the device’s lithium battery, the possibility of the implant’s wires migrating within the brain, and the difficulty of safely extracting the device without damaging brain tissue.

Following reports from Reuters about its animal experiments, Neuralink is also under federal investigation.

Employees at Neuralink told Reuters last year that under pressure from Elon Musk to get FDA approval, the company was rushing and botching procedures on monkeys, pigs, and sheep, killing more animals than necessary. According to the sources, the company’s application for human trials was supported by the data generated by the animal experiments.

One time in 2021, the business implanted the incorrect-sized devices in 25 out of 60 pigs. Employees claimed that with better planning, the mistake could have been easily avoided before the pigs were all killed.

After Reuters revealed potential financial conflicts on the board, US lawmakers urged regulators to look into whether the composition of Neuralink’s panel overseeing animal testing led to rushed and poorly executed experiments.

Separate investigations are being conducted by the Department of Transportation to determine whether Neuralink transported dangerous pathogens on chips taken from monkey brains without the proper containment procedures. On Friday, an agency representative stated that the investigation is still ongoing.

The Office of Inspector General for the US Department of Agriculture has also been looking into Neuralink for possible animal welfare violations. This investigation focused on the USDA’s control over Neuralink. Requests for comment from an agency spokesperson were not immediately fulfilled.

The company’s value has also increased dramatically in recent months. According to Reuters, the start-up was valued at close to $2 billion (roughly Rs. 16,382 crore) in a private fundraising round two years ago, and as of this month, based on privately executed stock trades, it is now worth about $5 billion (roughly Rs. 40,955 crore). Employees of Neuralink who served on the organization’s animal board, which has drawn federal attention due to potential financial conflicts of interest, stood to gain from the implant’s rapid development. Based on secondary trades, the value of the Neuralink stock that some employees own has increased by about 150% in just two years, according to Reuters.