Elon Musk, the billionaire entrepreneur and co-founder of Neuralink, announced during a webcast at the VivaTech event in Paris that the brain-chip startup plans to conduct its first human trial later this year.
While Musk did not specify the number of patients or the duration of the trial, he mentioned that Neuralink intends to implant a tetraplegic or paraplegic patient. This announcement follows the recent clearance granted by the US Food and Drug Administration (FDA) for Neuralink’s first-in-human clinical trial, a significant milestone for the company.
Despite facing investigations regarding its handling of animal experiments, Neuralink is making progress toward its goal of developing advanced brain-computer interface technology.
According to experts, even if Neuralink can demonstrate the safety of its device in human trials, it could still take several years, possibly more than a decade, to obtain clearance for commercial use.
Additionally, Neuralink faces competition from other neurotech companies that have already implanted their devices in individuals.
These factors highlight the regulatory challenges and the competitive landscape that Neuralink must navigate in order to bring its brain-chip technology to market for widespread commercial use.
Elon Musk has indeed faced delays and missed timelines in the past regarding Neuralink’s human trials. Since 2019, he has made at least four predictions about the imminent start of human trials that have not materialized.
In early 2022, Neuralink submitted an application to the FDA seeking permission for human trials, but it was reportedly rejected. The FDA raised concerns about numerous safety issues, including the lithium battery used in the device, the potential migration of the implant’s wires within the brain, and the safe extraction of the device without causing damage to brain tissue. These concerns highlight the complex technical and safety challenges that Neuralink must address before advancing to human trials and eventual commercial use.
It’s important to note that developing and gaining regulatory approval for medical devices, especially those involving novel and invasive technologies like brain implants, can be a lengthy and rigorous process due to the need to ensure patient safety and efficacy.
Neuralink is currently facing federal scrutiny following reports by Reuters about its animal experiments. According to previous Reuters reports, Neuralink employees claimed that the company rushed and mishandled surgeries on monkeys, pigs, and sheep, resulting in unnecessary animal deaths. These experiments were conducted to gather data in support of the company’s application for human trials. For example, in one case, 25 out of 60 pigs were implanted with incorrectly sized devices, leading to their subsequent euthanization.
The makeup of Neuralink’s panel overseeing animal testing has also raised concerns, with US lawmakers urging regulators to investigate potential financial conflicts of interest on the board. The US Department of Transportation is separately investigating whether Neuralink violated regulations by transporting dangerous pathogens on chips removed from monkey brains without proper containment measures.
Furthermore, the US Department of Agriculture’s Office of Inspector General has been investigating potential animal welfare violations at Neuralink and examining the USDA’s oversight of the company. The valuation of Neuralink has significantly increased in recent months, from around $2 billion in a private fundraising round two years ago to approximately $5 billion based on privately executed stock trades. Reuters reported that employees who served on the company’s animal board, which is under federal scrutiny, stood to benefit from the rapid development of the implant, as the value of Neuralink stock held by some employees increased by approximately 150% in just two years.
These investigations and reports highlight the regulatory and ethical concerns surrounding Neuralink’s animal experiments and raise questions about the company’s adherence to safety protocols and animal welfare standards.
