JUNE 19, 2023
Elon Musk announced at the VivaTech event in Paris that his brain-chip start-up, Neuralink, is planning to conduct its first human trial later this year. During a webcast monitored by Reuters, Musk mentioned that Neuralink intends to implant the brain chip in a tetraplegic or paraplegic patient.
While he did not provide specifics on the number of patients or the duration of the trial, Musk indicated that the first case is expected to occur in the near future.
Permission for human trials did not come easy
Last month, Neuralink achieved a significant milestone when it received clearance from the US Food and Drug Administration (FDA) for its first-in-human clinical trial. This regulatory approval holds great importance for the start-up, especially as it faces an investigation in the United States regarding its handling of animal experiments.
While the FDA confirmed that it granted Neuralink permission to utilize its brain implant and surgical robot for the trials, further details were not disclosed.
If Neuralink can demonstrate the safety of its device in human subjects, it would still require several years, potentially more than a decade, to obtain commercial-use clearance.
According to experts interviewed by Reuters, the company faces competition from other neurotech companies that have already implanted similar devices in humans. It is worth noting that Musk has previously missed timelines for Neuralink’s milestones, having made several public announcements since 2019 about the imminent commencement of human trials.
Neuralink’s run-ins with the law
Neuralink, established in 2016, initially sought FDA approval early last year but had its application rejected due to numerous safety concerns.
Issues raised by the FDA included the lithium battery of the device, the potential migration of the implant’s wires within the brain, and the challenge of extracting the device safely without causing damage to brain tissue, as reported by Reuters.
Neuralink also faces federal scrutiny, following Reuters reports about its animal experiments.
Last year, employees of Neuralink expressed concerns to Reuters about the company’s hurried and mishandled surgeries on animals such as monkeys, pigs, and sheep. These rushed procedures resulted in unnecessary animal deaths, allegedly due to Elon Musk’s pressure on staff to obtain FDA approval. The purpose of these animal experiments was to gather data to support Neuralink’s application for human trials, according to insider sources.
Musk’s Neuralink accused of animal abuse
A specific incident occurred in 2021 when 25 out of 60 pigs were implanted with incorrectly sized devices, leading to the euthanization of all the affected pigs. Employees believe that this error could have been easily prevented with better preparation.
Following a report by Reuters on potential financial conflicts within Neuralink’s animal testing oversight panel, US lawmakers called for an investigation by regulators into the matter. They wanted to determine if these conflicts had contributed to the company’s rushed and flawed experiments.
The US Department of Transportation is conducting a separate investigation into whether Neuralink violated regulations by transporting hazardous pathogens on chips removed from monkey brains without proper containment measures. The investigation is currently ongoing, according to an agency representative.
Moreover, the US Department of Agriculture’s Office of Inspector General has been investigating Neuralink for possible violations of animal welfare regulations. The focus of this inquiry is the USDA’s oversight of Neuralink’s activities. A comment request made to an agency representative regarding this matter has yet to receive a response.
No stopping Elon Musk’s BCI company
Despite these investigations and controversies, Neuralink’s valuation has significantly increased in recent months. The company, which was valued at nearly $2 billion in a private fundraising round two years ago, is now estimated to be worth around $5 billion based on privately executed stock trades, as reported by Reuters.
Certain Neuralink employees who were part of the company’s animal board, which has faced scrutiny for potential financial conflicts, stood to gain from the rapid development of the implants. According to Reuters, the value of Neuralink stock held by some of these employees has risen by approximately 150 per cent over a span of two years in secondary trades.
Courtesy/Source: Firstpost / PTI