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Billionaire entrepreneur Elon Musk expressed his anticipation for the first human trial by his brain-chip startup Neuralink this year.
Neuralink demo setup uses a physical model (with brain-like material and vasculature in the hard shell skull) to demonstrate the electrode insertion process. Image credit: Steve Jurvetson via Flickr, CC BY 2.0
During a speech at the VivaTech event in Paris, billionaire entrepreneur Elon Musk announced that his brain-chip startup Neuralink is expected to initiate its first human trial this year.
Musk revealed that the company intends to implant its chip in a brain of a patient with tetraplegia or paraplegia. Although the exact number of patients and duration of the trial were not specified, Musk stated that it seems likely that the first case will occur later in the year.
Neuralink achieved a significant milestone recently when it obtained clearance from the U.S. Food and Drug Administration (FDA) for its inaugural clinical trial involving humans. The FDA confirmed that it granted Neuralink permission to conduct trials using its brain implant and surgical robot but refrained from providing further details.
According to experts, if Neuralink can demonstrate the safety of its device in humans, it would still take several years, or even over a decade, for the startup to obtain clearance for commercial use. Furthermore, the developer faces competition from other neurotech companies that have already implanted their devices in people.
Musk has previously experienced delays in meeting the timelines he publicly set for Neuralink.
Founded in 2016, Neuralink initially applied for FDA permission in early 2022, but the application was rejected due to numerous safety concerns. These concerns included issues related to the lithium battery of the device, the potential migration of the implant’s wires within the brain, and the difficulty of extracting the device without causing damage to brain tissue.
Neuralink electrode insertion demo, close-up photo. Image credit: Steve Jurvetson via Flickr, CC BY 2.0
Furthermore, Neuralink is currently under federal scrutiny for its animal experiments. According to employees, the company hurried and mishandled surgeries on monkeys, pigs, and sheep, resulting in more animal deaths than necessary, allegedly due to Musk’s pressure to obtain FDA approval. These animal experiments were conducted to gather data in support of the company’s application for human trials.
In one instance in 2021, the company mistakenly implanted the wrong-sized devices in 25 out of 60 pigs, ultimately leading to the euthanization of all the pigs involved. Employees stated that this error could have been easily avoided with better preparation.
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In a separate investigation, the Department of Transportation is examining whether Neuralink unlawfully transported hazardous pathogens on chips removed from monkey brains without implementing proper containment measures. The investigation is ongoing, according to a spokesperson from the agency.
Additionally, Neuralink has been under scrutiny by the U.S. Department of Agriculture’s Office of Inspector General for potential violations related to animal welfare.
Meanwhile, the valuation of Neuralink has significantly increased in recent months. In a private fundraising round two years ago, the startup was valued at nearly $2 billion, but recent privately conducted stock trades have raised its value to approximately $5 billion.
Written by Alius Noreika
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