Neuralink, the brain-chip startup co-founded by Elon Musk, is poised to embark on its first-ever human trial, signaling a major milestone in the field of brain-computer interfaces. During the recent VivaTech event in Paris, Musk expressed his anticipation for Neuralink to initiate the groundbreaking clinical trial.
Having received clearance from the US Food and Drug Administration (FDA) for its first-in-human clinical trial just last month, Neuralink has achieved a crucial step forward in its mission to revolutionize the way we interact with technology and augment human capabilities.
Musk shared that Neuralink plans to implant its innovative brain-chip technology in a tetraplegic or paraplegic patient. While specific details regarding the number of participants and trial duration were not disclosed, Musk stated that the first case is expected to take place later this year. This development is in addition to Musk’s roles as CEO of Tesla, Twitter, and SpaceX, further highlighting his multifaceted endeavors and his dedication to pushing the boundaries of innovation.
The FDA clearance for Neuralink’s clinical trial holds significant weight, particularly in light of ongoing investigations surrounding the company’s approach to animal experiments. While the FDA confirmed the approval for Neuralink’s brain implant and surgical robot for trials, they refrained from providing further specifics at this time.
However, even if Neuralink successfully demonstrates the safety and efficacy of its device in human subjects, it will likely take several years, potentially even more than a decade, to obtain commercial use clearance. The company faces competition from other neurotechnology firms that have already made progress in implanting their devices in humans.
It’s important to note that Musk has previously missed timelines for Neuralink’s human trials. Despite publicly predicting the initiation of human trials on at least four occasions since 2019, the intricate nature of developing such advanced technology has presented challenges along the way.
Founded in 2016, Neuralink encountered setbacks when it initially sought FDA permission in early 2022, leading to the rejection of its application due to numerous safety concerns. Reuters reported issues related to the device’s lithium battery, the potential for wire migration within the brain, and the challenge of safely removing the implant without causing damage to the delicate brain tissue.
Furthermore, Neuralink has faced scrutiny in the wake of reports about rushed and flawed animal experiments. Insiders disclosed that surgeries on monkeys, pigs, and sheep were conducted hastily, resulting in avoidable animal deaths. Allegedly, Musk exerted pressure on staff to expedite the process in order to meet FDA approval requirements. The data derived from these experiments was intended to support the application for human trials.
In a particularly distressing incident in 2021, 25 out of 60 pigs were implanted with incorrectly sized devices, leading to their subsequent euthanasia. Employees claimed that with adequate preparation, such a mistake could have been easily avoided.
Responding to concerns about potential conflicts of interest on the board overseeing animal testing, US lawmakers have urged regulators to investigate whether these factors contributed to the botched and rushed experiments. Additionally, the Department of Transportation is conducting a separate investigation into allegations of illegal transportation of pathogens on chips removed from monkey brains, highlighting concerns regarding proper containment measures.
Furthermore, the US Department of Agriculture’s Office of Inspector General has initiated an investigation into potential animal welfare violations at Neuralink, focusing on the USDA’s oversight of the company’s practices.
Despite these obstacles, Neuralink’s valuation has skyrocketed in recent months. From an approximate valuation of $2 billion during a private fundraising round two years ago, the company’s worth has now reached an estimated $5 billion based on privately executed stock trades. This substantial growth has resulted in a significant increase in the value of Neuralink stock held by employees who served on the company’s animal board, which is currently under scrutiny for possible financial conflicts.
As Neuralink moves closer to its first human trial, the world eagerly awaits the outcomes and potential implications of this pioneering endeavor. The intersection of advanced technology and neuroscience holds the promise of transforming our understanding of the human brain and opening doors to extraordinary advancements in medical science. While challenges and scrutiny persist, the ultimate goal of improving the lives of individuals with neurological conditions remains at the forefront of Neuralink’s mission.
