Neuralink Corp., Elon Musk's brain-computer interface startup, announced Tuesday it received approval to begin recruiting patients for its first ever human trial.
"We are happy to announce that we’ve received approval from the reviewing independent institutional review board and our first hospital site to begin recruitment for our first-in-human clinical trial," the Fremont-based company said in a statement posted on its corporate blog.
The company has christened the trial "the PRIME Study (short for Precise Robotically Implanted Brain-Computer Interface)."
Neuralink previously said it has developed a fully implantable, wireless brain-computer interface (BCI) designed to be implanted in human skulls and connected by fine wires to nerves in people's brains.
The aim of the trial is to evaluate the safety of both its implant and the surgical robot used to get it into a patient's brain to see how well it lets "people with paralysis to control external devices with their thoughts."
The company said its device could eventually be used to treat a range of neurological and other condition. Among those it could help: quadriplegics who have a cervical spinal cord injury or those who suffer from ALS, which is known as Lou Gehrig’s disease.
It's been an eventful year for the company and its founder, Musk, the CEO of Tesla and owner of the social media platform X. In August, Neuralink received a Series D funding round of $280 million led by Peter Thiel's Founders Fund. The company has raised a total of more than $617 million and has an estimated $3.48 billion valuation, according to PitchBook Data.
But getting approval to begin trials proved difficult. The U.S. Food and Drug Administration initially denied permission for Neuralink to begin human trials. However, in May the agency granted approval for an investigational device exemption (IDE) that allowed the company's devices to be used for clinical studies.
And last December, the U.S. Department of Agriculture’s inspector general opened an inquiry into the company following complaints by staff that rushed testing caused needless suffering and deaths of 1,500 animals laboratory animals — among them, 280 monkeys, pigs, and sheep.
