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Elon Musk’s startup Neuralink to begin human trials: What does the company do and why is it so controversial?

Neuralink will begin recruiting patients for the first human trials of its brain-computer interface implant, but questions persist about safety.

Neuralink to test brain-chip implants in humans

Biotech company Neuralink announced on Tuesday that it had received a green light from an independent review board to begin recruiting human test subjects for its brain-computer interface implant. The startup co-founded by billionaire entrepreneur Elon Musk seeks to use its brain-chips to treat a number of ailments including autism, depression, obesity and schizophrenia as well as memory loss.

The first human trials of its technology straight out of science fiction will focus on restoring motor functions in people with paralysis due to cervical spinal cord injury or amyotrophic lateral sclerosis. The company said it had received approval from the FDA in May, however, the agency previously had raised safety concerns and denied the requested 10 patient pool of participants. The exact number of people that the FDA will allow to participate is unknown.

Elon Musk’s startup Neuralink to begin human trials: What does the company do and why is it so controversial?

The neurotechnology company was launched in 2016 by Musk along with a team of seven scientists and engineers going public in March 2017. The controversial billionaire has been predicting human trials since 2019 but the company hadn’t sought approval from the Food and Drug Administration until 2022.

The pace at which he wants the technology to come to market has been a source of friction at the company. Nearly all of the eight founding members have left the company.

A source within the company told Reuters that at one late-night meeting Musk expressed his irritation about the company’s slow regulatory progress. The source said that the billionaire wants the biotech company to operate like his electric vehicle company Tesla.

“He can’t appreciate that this is not a car. This is a person’s brain. This is not a toy,” the source said. Reportedly, executives at the company have told Musk that his expected timeline is unrealistic to which he informed them “that he would make FDA understand the need for fast approvals.”

Calls for Musk to be investigated about falsely saying no test monkeys died because of brain implants

Shortly after its founding Neuralink acquired a sizeable number of animal subjects for experiments with its brain-computer interface implant technology. Wired reports that contrary to Musk’s claims that none of the test animals died due to the brain implants, researchers had to euthanized at least three monkeys after they began to suffer gruesome complications linked to the implants.

The federal government launched an investigation last year into the company’s treatment of research animals including pigs and sheep as well as macaques. The Physicians Committee for Responsible Medicine, a nonprofit striving to abolish live animal testing, has sent letters to the US Securities and Exchange Commission (SEC) calling on the agency to investigate Musk.

The medical ethics group is claiming that the billionaire publically lied when he denied that any of the monkeys’ deaths were “a result of a Neuralink implant.” He also said that researchers had chosen test subjects that were “close to death” and that the experimentation was conducted to confirm fully formed scientific hypotheses and never “exploratory.”

The group says that Musk knew his comments were false and that they were misleading for investors in order for them to properly ascertain the safety and marketability of Neuralink’s speculative product. The company has raised $280 million from outside investors which would bring the situation under the jurisdiction of the SEC for potential securities fraud.

In a series of stock trades in June, Neuralink was valued at $5 billion according to Reuters, up from $2 billion just two years ago.