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| Elon Musk's Neuralink |
Billionaire entrepreneur Elon Musk announced that his brain-chip startup, Neuralink, is expected to conduct its first human trial this year.
During the VivaTech event in Paris, Musk revealed that Neuralink plans to implant a tetraplegic or paraplegic patient. While the exact number of patients and the duration of the trial were not specified, Musk stated that it is likely to begin later this year.
Neuralink recently received clearance from the US Food and Drug Administration (FDA) for its first-in-human clinical trial, a significant achievement for the startup amid ongoing US investigations into its animal experiments. The FDA cleared Neuralink's brain implant and surgical robot for the trials, but further details were not disclosed.
Even if Neuralink can demonstrate the safety of its device in human trials, obtaining commercial use clearance could still take several years, potentially more than a decade, according to experts. The company is facing competition from other neurotech companies that have already implanted their devices in humans.
Elon Musk has made previous predictions about Neuralink's progress, but timelines have been missed on multiple occasions since 2019 regarding the start of human trials.
The company, established in 2016, initially applied for FDA permission in early 2022, but the application was rejected due to numerous safety concerns. These concerns included issues with the lithium battery of the device, the possibility of the implant's wires migrating within the brain, and the difficulty of safely removing the device without causing damage to brain tissue.
Last year, Neuralink faced allegations from employees who claimed that the company rushed and mishandled surgeries on animals like monkeys, pigs, and sheep, leading to more animal deaths than necessary. Elon Musk's pressure on staff to obtain FDA approval was said to be a factor in these issues. The animal experiments were conducted to gather data to support the company's application for human trials.
In one specific incident in 2021, 25 out of 60 pigs were implanted with incorrectly sized devices, resulting in the death of all the pigs. Employees believed that better preparation could have prevented this error.
Following reports of potential financial conflicts on the board overseeing animal testing, US lawmakers called for an investigation into the board's composition and its impact on the quality of experiments.
Neuralink is also under investigation by the Department of Transportation for allegedly transporting dangerous pathogens on chips removed from monkey brains without proper containment measures.
Additionally, the US Department of Agriculture's Office of Inspector General is investigating potential animal-welfare violations and the USDA's oversight of Neuralink.
Despite these controversies, the company's valuation has significantly increased in recent months, with a current estimated value of around $5 billion based on privately executed stock trades. Some Neuralink employees holding stock in the company have seen a substantial increase in the value of their shares, around 150% in just two years, based on secondary trades.