Neuralink to Begin Test on Human Subjects.

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

Speaking at the VivaTech event in Paris, co-founder Musk said Neuralink plans to implant a tetraplegic or paraplegic patient during a webcast monitored by Reuters. While Musk didn’t specify how many patients his company would implant or for how long, “it’s looking like the first case will be later this year,” said Musk, who is also CEO of electric carmaker Tesla, social media platform Twitter and the SpaceX rocket launch company.

Last month, Neuralink said it received US Food and Drug Administration (FDA) clearance for its first-in-human clinical trial, a critical milestone for the startup as it faces US probes over its handling of animal experiments. The FDA acknowledged in an earlier statement to Reuters that the agency cleared Neuralink to use its brain implant and surgical robot for trials but declined to provide more details.

If Neuralink can prove its device is safe in humans, it would still take several years, potentially more than a decade, for the start-up to secure commercial use clearance, experts earlier told Reuters. The company is also competing with other neurotech companies which have already implanted their devices in people.

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, Reuters has reported. 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 Reuters reports about its animal experiments.

Last year, Neuralink employees told Reuters 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.

In one instance in 2021, the company implanted 25 out of 60 pigs with the wrong-sized devices. All the pigs were subsequently killed – an error that employees said could have been easily avoided with more preparation.

In May, US lawmakers urged regulators to investigate whether the makeup of Neuralink’s panel overseeing animal testing contributed to botched and rushed experiments after Reuters reported 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 US 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.

Meanwhile, the company’s valuation has shot up in recent months. The start-up was valued at close to $2 billion (roughly Rs. 16,382 crore) in a private fundraising round two years ago and is now worth around $5 billion (roughly Rs. 40,955 crore) based on privately executed stock trades, Reuters reported this month. Neuralink employees who sat on the company’s animal board, which has come under federal scrutiny for potential financial conflicts, stood to benefit from the implant’s quick development. Neuralink stock that some of the employees hold has jumped around 150% in value in just two years, based on the secondary trades, Reuters reported.

© Thomson Reuters 2023.