Billionaire businessman Elon Musk expects his brain chip startup Neuralink to begin its first human trial this year, he said in France on Friday.
Speaking at the VivaTech event in Paris, co-founder Musk said Neuralink plans to implant a quadriplegic or paraplegic patient during a webcast monitored by Reuters. While Musk did not specify how many patients his company would implant or for how long, “it looks like the first case will be later this year,” said Musk, who is also chief executive of electric car maker Tesla, the social media platform Twitter. and the SpaceX Rocket Launch Company.
Last month, Neuralink said it received clearance from the US Food and Drug Administration (FDA) for its first human clinical trial, a critical milestone for the startup as it faces US investigations into its management of animal experiments. The FDA acknowledged in an earlier statement to Reuters that it had authorized Neuralink to use its brain implant and surgical robot for trials, but declined to provide further details.
If Neuralink can prove its device is safe in humans, it would take several years, potentially more than a decade, for the startup to gain commercial use clearance, experts previously told Reuters. The company also competes with other neurotech companies that have already implanted their devices in people.
However, Musk has missed the deadlines for his public pronouncements on Neuralink. On at least four occasions since 2019, Musk predicted that Neuralink would soon begin human testing.
The company, founded in 2016, first applied for permission from the FDA in early 2022, and the agency rejected the request, citing dozens of safety concerns, Reuters reported. Some of the issues involved the device’s lithium battery, the possibility of implant wires migrating into the brain, and the challenge of safely removing the device without damaging brain tissue.
Neuralink is also facing federal scrutiny following Reuters reports of 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 lobbied staff for FDA approval. . The animal experiments produced data intended to support the company’s application for human trials, the sources said.
In one case in 2021, the company implanted devices of the wrong size in 25 of 60 pigs. All the pigs were subsequently killed, a mistake that employees say could have easily been prevented with more preparation.
In May, US lawmakers urged regulators to investigate whether the composition of Neuralink’s panel that oversees animal testing contributed to botched and rushed experiments after Reuters reported on possible financial conflicts on the board.
The Department of Transportation is separately investigating whether Neuralink illegally transported dangerous pathogens on chips extracted from monkey brains without proper containment measures. An agency spokesman said Friday that the investigation is ongoing.
Neuralink has also been investigated by the US Department of Agriculture’s Office of the Inspector General for possible animal welfare violations. This investigation has been looking at USDA oversight of Neuralink. An agency spokesperson did not immediately respond to a request for comment.
Meanwhile, the company’s valuation has skyrocketed in recent months. The startup 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 crores) based on privately executed stock transactions, Reuters reported this month. Neuralink employees who were on the animal board of the company, which has come under federal scrutiny for possible financial conflicts, benefited from the rapid development of the implant. Neuralink shares held by some of the employees have risen around 150% in value in just two years, based on secondary trading, Reuters reported.
© Thomson Reuters 2023