Elon Musk, the billionaire entrepreneur, announced at the VivaTech event in Paris that his brain-chip startup, Neuralink, is planning to carry out its first human trial later this year. The company aims to implant a tetraplegic or paraplegic patient during a webcast monitored by Reuters.
Human Trials and FDA Clearance
Last month, Neuralink received clearance from the US Food and Drug Administration (FDA) for its first-in-human clinical trial, which is a critical milestone for the startup. However, the company is still facing US probes over its handling of animal experiments. The FDA cleared Neuralink to use its brain implant and surgical robot for trials, but declined to provide more details.
If Neuralink can prove that 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, according to experts. The company is also competing with other neurotech companies that have already implanted their devices in people.
Challenges for Neuralink
Neuralink has faced several challenges, including rejection of its application by the FDA in early 2022, citing dozens of safety concerns. 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.
The company has also been under federal scrutiny following reports about its animal experiments. Neuralink employees told Reuters last year that 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.
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.
Valuation and Conclusion
Despite these challenges, 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. 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.
Elon Musk’s Neuralink plans to start its first human trial this year, but it faces several challenges and federal probes over its handling of animal experiments. If the company can prove that its device is safe in humans, it would still take several years for the start-up to secure commercial use clearance. Despite these challenges, the company’s valuation has increased significantly in recent months.
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