Shulou(Shulou.com)11/24 Report--

CTOnews.com, June 18 (Reuters)-billionaire entrepreneur Elon Musk said at a VivaTech event in Paris on June 16 that his brain-computer interface startup Neuralink plans to conduct its first human trial this year. Musk said Neuralink plans to implant a device into a quadriplegic or amputated patient.

Musk did not say how many patients Neuralink would be implanted or how long it would last, but he said the first trial would be conducted later this year.

Last month, Neuralink said it had obtained approval for human clinical trials from the U.S. Food and Drug Administration (FDA), a key milestone for the startup. In an earlier statement to Reuters, FDA confirmed that the agency had approved Neuralink's use of its brain implants and surgical robots to conduct experiments, but declined to provide further details.

Experts say that even if Neuralink can prove that its devices are safe in the human body, it will still take several years, or even more than a decade, for the company to obtain a commercial license. The company also faces competition from other neurotechnology companies that have implanted their own devices in the human body.

CTOnews.com notes that Musk has predicted at least four times since 2019 that Neuralink will soon begin human trials. The company first applied to FDA for permission in early 2022 and was rejected by the agency on the grounds of dozens of safety issues, some of which related to the device's lithium battery, the possibility that the wires of the implant could move through the brain and the challenge of safely removing the device without damaging brain tissue.

Neuralink is also under scrutiny by federal regulators for its animal experiments. Last year, Neuralink employees revealed that the company had rushed and made mistakes in performing operations on monkeys, pigs and sheep after Musk put pressure on employees to obtain FDA approval, resulting in unnecessary animal deaths. The data from animal experiments are designed to support the company's application to conduct human trials. In one experiment in 2021, the company implanted wrong-sized devices into 25 of 60 pigs, all of which were then killed, employees said. This mistake could have been easily avoided if there had been more preparation.

In May, after Reuters reported possible financial conflicts of interest in the company's overseeing animal testing committee, members of Congress urged regulators to investigate whether the committee's composition led to hasty and erroneous experiments. The Department of Transportation is also separately investigating whether Neuralink illegally transported chips with dangerous pathogens removed from monkeys' brains without proper protection. An agency spokesman said Friday that the investigation was ongoing. Neuralink is also under investigation by the Inspector General of the Office of the United States Department of Agriculture on suspicion of violating animal welfare laws.

Meanwhile, Neuralink's valuation has soared in recent months. The company, which was valued at nearly $2 billion in a round of private equity two years ago, is now valued at about $5 billion based on secondary market trading (CTOnews.com Note: about 35.65 billion yuan), according to a Reuters report this month.

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