Neuralink, Elon Musk’s Brain Chip Company, to Launch Human Testing in 2021

During his visit to France on Friday, billionaire entrepreneur Elon Musk announced that his brain-chip startup Neuralink is anticipated to commence its initial human trial this year.

Speaking at the VivaTech event in Paris, co-founder Musk said Neuralink plans to implant a tetraplegic or paraplegic patient during a webcast moderated by Reuters.

While Musk did not specify how many patients his company would implant or for how long, “it looks like the first case will happen later this year,” said Musk, who also owns electric car maker Tesla, social media Twitter and rocket launch company SpaceX .

Last month, Neuralink said it had received approval from the US Food and Drug Administration (FDA) for its first human clinical trial, a critical milestone for the company as it faces US investigations into its handling of animal experiments.

In an earlier statement to Reuters, the FDA acknowledged that the agency gave Neuralink permission to use its brain implant and surgical robot for trials, but declined to provide further details.

If Neuralink can prove its device is safe for humans, it would be several more years, possibly more than a decade, before the company is licensed for commercial use, experts previously told Reuters. The company also competes with other neurotechnology companies that have already implanted their devices in people.

However, Musk has missed timelines in his public statements about Neuralink. Musk has predicted at least four times since 2019 that Neuralink will soon begin human trials.

The company, founded in 2016, first applied for approval from the FDA in early 2022, and the agency rejected the application, citing dozens of safety concerns, Reuters has reported.

Some of the issues are related to the device’s lithium battery, the potential for the implant’s wires to move around in the brain, and the challenge of safely removing the device without damaging brain tissue.

Neuralink is also facing federal scrutiny after Reuters revealed its animal testing.

Last year, Neuralink employees told Reuters that the company rushed and rushed surgeries on monkeys, pigs and sheep, resulting in more animal deaths than necessary as Musk pushed staff to get FDA approval. According to the sources, the animal experiments produced information that is intended to support the company’s application in human experiments.

In one case in 2021, the company implanted the wrong size devices in 25 out of 60 pigs. All the pigs were later killed – a mistake that workers say could have easily been avoided with better preparation.

In May, US lawmakers called on regulators to investigate whether the makeup of Neuralink’s animal testing panel influenced the failed and rushed trials after Reuters reported on possible financial conflicts within the board.

The Department of Transportation is separately investigating whether Neuralink illegally transported dangerous pathogens with chips removed from monkey brains without proper isolation measures. The agency’s spokesperson said on Friday that the investigation is ongoing.

Neuralink has also been investigated by the US Department of Agriculture’s inspector general for possible animal welfare violations. This probe has reviewed the USDA’s Neuralink monitoring. A spokesperson for the agency did not immediately respond to a request for comment.

At the same time, the company’s valuation has risen in recent months. The startup was valued at nearly $2 billion in a private fundraising round two years ago and is now valued at about $5 billion based on private equity deals, Reuters reported this month.

Neuralink employees who sat on the animal board of the company, which has come under federal scrutiny for potential financial conflicts, benefited from the implant’s rapid development.

Neuralink shares held by some employees have increased in value by about 150% in just two years based on secondary trades, Reuters reported.