Elon Musk, the billionaire entrepreneur, has announced plans for Neuralink, his brain-chip startup, to conduct its first human trial later this year.
Speaking at the VivaTech event in Paris, Musk stated that the initial recipient of the implant could be a tetraplegic or paraplegic patient.
While the exact number of participants and trial duration were not specified, Musk expressed confidence that the first case would likely take place in the near future.
This announcement comes after Neuralink recently obtained clearance from the U.S. Food and Drug Administration (FDA) for its first-in-human clinical trial, marking a significant milestone for the company.
Neuralink’s journey has not been without obstacles. The startup has faced scrutiny from U.S. authorities regarding its handling of animal experiments.
Last year, reports emerged that surgeries on monkeys, pigs, and sheep were being rushed and botched, resulting in unnecessary animal deaths.
According to insiders, Musk’s push for FDA approval put significant pressure on staff, leading to compromised procedures. Data collected from these animal experiments was intended to support Neuralink’s application for human trials.
The FDA initially rejected Neuralink’s application in 2022 due to numerous safety concerns. These included issues with the device’s lithium battery, the potential migration of implant wires within the brain, and the challenge of safely extracting the implant without causing harm to brain tissue.
The clearance granted by the FDA allows Neuralink to proceed with its brain implant and surgical robot for human trials, although specific details were not disclosed.
If Neuralink can demonstrate the safety and effectiveness of its device in human trials, it would still face a lengthy path to commercial use clearance, which experts estimate could take several years or even more than a decade.
The startup also faces competition from other neurotech companies that have already successfully implanted similar devices in individuals.
Elon Musk’s Vision for Neuralink
Elon Musk’s history with Neuralink includes missed timelines and delayed milestones. Since 2019, he has made several predictions about the imminent start of human trials, none of which have materialized. This track record has raised skepticism and caution among observers.
The controversies surrounding Neuralink have attracted attention beyond the scientific community. U.S. lawmakers have urged regulators to investigate the potential financial conflicts within Neuralink’s animal testing oversight panel.
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Concerns have been raised about rushed and botched experiments due to these conflicts. The Department of Transportation is conducting a separate probe into whether Neuralink illegally transported dangerous pathogens on chips removed from monkey brains without proper containment measures.
Additionally, the U.S. Department of Agriculture’s Office of Inspector General is investigating potential animal welfare violations and the USDA’s oversight of Neuralink.
Despite these challenges, Neuralink’s valuation has surged in recent months. The startup was valued at nearly $2 billion in a private fundraising round two years ago, but its current value is estimated to be around $5 billion based on privately executed stock trades.
Some Neuralink employees who served on the company’s animal board, which is currently under federal scrutiny, have significantly benefited from the rapid development of the implant.
Their Neuralink stock has witnessed a substantial increase in value, approximately 150%, over the past two years based on secondary trades.
Samridhi holds a Bachelor’s degree in Economics. Her research interests lie in examining the intersection of the social sector with poverty and inequality,
Along with this she is keen in understanding the systemic and structural issues that governs growth and development with an interdisciplinary focus.