WOMENeuralink Corp., Elon Musk’s brain transplant company, said it has received approval from the US Food and Drug Administration to conduct clinical trials on humans.
“This is the result of the Neuralink team’s incredible work in close collaboration with the FDA and represents an important first step that will one day allow our technology to help many people,” said the company. company said Thursday in a tweet.
The FDA and Neuralink did not immediately respond to requests for comment.
Musk’s startup is developing a small device that will link the brain to a computer, including wires of electrodes. Place the device that requires drilling into the skull.
“Approval is “really a big deal,” said Cristin Welle, a former FDA official and associate professor of neurosurgery and physiology at the University of Colorado. “They can start human trials, meaning they’ve passed safety preclinical testing and bench testing,” she said, meaning testing for mechanical and design flaws, as well as longevity and biocompatibility.
Founded in 2016, Neuralink has attracted some of the top neuroscientists involved in brain transplant research, though many have since moved on to other companies or academia. Musk, who also runs the automaker Tesla and owns the social network Twitter, has for years said that the company was close to achieving FDA approval for human tests.
The company’s device aims to help people with paralysis or traumatic brain injury communicate and control computers using only their thoughts. Finally, in addition to helping the sick, Musk theorized that the device could help humanity keep up with advances made by artificial intelligence.
Neuralink is not the first brain-computer interface company to enter human trials. The field has become competitive since the company’s inception. For example, Synchron has enrolled its first US patient in a clinical trial, putting the company’s implantable device on the path towards possible regulatory approval for wider use in the US. paralyzed people. Synchron’s device is less invasive than Neuralink’s and works using a different technology.
Musk’s startup has sounded the alarm with several animal rights groups for testing on primates. The U.S. Department of Transportation has begun investigating the company after an animal rights group said it received an email indicating the startup failed to follow proper process when shipping animals. Materials may be hazardous.
Despite experimental FDA approval, widespread brain transplantation has yet to occur. Welle says Neuralink’s device is still at least five to 10 years away from commercialization. Setting up a trial and recruiting patients will take several months. Synchronization has taken almost a year since it announced that it had received FDA approval for its first patient in the US and actually implanted the device in July 2022. Usually, the trials. The first human trial enrolled five to 10 patients and took about six months, Welle said.
The human-first study allows the company to tailor its device design depending on the outcome without having to restart the entire FDA registration process. “It gives you flexibility,” says Welle.
If the research goes well, Neuralink could then begin what is known as a feasibility study and eventually a pivotal study, similar to a phase III study for a drug.
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