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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 in a private fundraising round two years ago and is now worth around $5 billion 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. © Reuters