Elon Musk expects his brain-chip startup Neuralink to start its first human trial in 2023, he said in France. Speaking at the VivaTech event in Paris, co-founder Elon Musk said Neuralink plans to implant a tetraplegic or paraplegic patient during a webcast monitor by Reuters.
While Elon 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 Elon Musk, who is also CEO of electric carmaker Tesla, social media platform Twitter and the SpaceX rocket launch company.
Neuralink said it receive 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 acknowledge in an earlier statement to Reuters that the agency clear Neuralink to use its brain implant and surgical robot for trials but decline to provide more details.
If Neuralink can prove its device is safe in humans, it would still take many years, potentially more than a decade, for the start-up to secure commercial use clearance, experts earlier told Reuters.
Neuralink is also competing with other neurotech companies which have already implanted their devices in people.
Elon Musk has miss timelines on his public pronouncements about Neuralink before.
On at least four occasions since 2019, Elon Musk predict that Neuralink would soon start human trials.
The Neuralink, founded in 2016, first sought permission from the FDA in early 2022, and the agency reject the application, citing dozens of safety concerns, as per Reuters report.
Some of the issues involve 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.
Neuralink employees told Reuters the company was rushing and botching surgeries on monkeys, pigs and sheep, resulting in more animal deaths than necessary, as Elon Musk pressure staff to receive FDA approval.
The animal experiments produce data intend to support the company’s application for human trials, as per sources said.
In one instance in 2021, Neuralink implant 25 out of 60 pigs with the wrong-size devices.
All the pigs were subsequently kill, an error that employees said could have easily avoid with more preparation.
In May, US lawmakers urge regulators to investigate whether the makeup of Neuralink’s panel overseeing animal testing contribute to botch and rush experiments after Reuters report on potential financial conflicts on the board.
The Department of Transportation is separately probing whether Neuralink illegally transport dangerous pathogens on chips remove from monkey brains without proper containment measures.
An agency spokesperson said the investigation is ongoing.
Neuralink has also under investigation by the US Department of Agriculture’s Office of Inspector General for potential animal-welfare violations.
This probe has looking at the USDA’s oversight of Neuralink.
An agency spokesperson didn’t immediately respond to a comment request.
Neuralink’s valuation has shot up in recent months.
The start-up was value at close to $2 billion (approx. Rs. 16,382 crore) in a private fundraising round two years ago and is now worth around $5 billion (approx. 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 jump around 150% in value in just two years, based on the secondary trades, as Reuters report.
