Elon Musk, a multibillionaire businessman, announced 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. 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 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 offer further information.
Even if Neuralink can demonstrate that its product is safe for human use, it might still take more than a decade for the start-up to obtain commercial usage permission, experts have told Reuters. The business is also in competition with other neurotech firms whose products have previously been implanted in people.
However, Musk has already been late with his public announcements about Neuralink. Since 2019, Musk has made at least four predictions about when Neuralink might begin conducting human testing.
The FDA first denied the business’s request for approval in early 2022, citing a number of safety concerns, according to Reuters. The company was created in 2016. Some of the problems included the implant’s lithium battery, the potential for the wires to migrate inside the brain, and the difficulty of properly removing the device without injuring the brain.
Following revelations from Reuters regarding its animal trials, Neuralink is also under federal investigation.
Employees at Neuralink told Reuters last year that under pressure from Musk to get FDA approval, the company was hurrying 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 research.
One time in 2021, the business inserted the incorrect-sized implants in 25 out of 60 pigs. Employees claimed that with better planning, the mistake might have been easily avoided before the pigs were all killed.
After Reuters revealed potential financial conflicts on the board, U.S. senators requested regulators to look into whether the composition of Neuralink’s panel regulating animal testing led to rushed and poorly executed tests.
Separate investigations are being conducted by the Department of Transportation to determine whether Neuralink transferred harmful germs on chips taken from monkey brains without the required containment procedures. On Friday, an agency representative stated that the inquiry is still ongoing.
The Office of Inspector General for the U.S. Department of Agriculture has also been looking into Neuralink for possible animal welfare breaches. This investigation focused on the USDA’s control over Neuralink. Requests for comment from an agency spokeswoman were not immediately fulfilled.
The company’s value has also increased dramatically in recent months. Reuters reported this month that the start-up, which was valued at close to $2 billion in a private fundraising round two years ago, is now worth almost $5 billion as a result of secretly performed stock trades.
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 secondary trading, the value of the Neuralink shares that some employees own has increased by over 150% in just two years, according to Reuters.
(Adapted from NYPost.com)









