Musk's Neuralink seeks a clinical trial partner as it awaits FDA go-ahead: Reuters

Seemingly undeterred by reports earlier this month that the FDA had rejected an early 2022 request from Neuralink to begin a clinical trial of its brain implant, the brain-computer interface outfit is reportedly plowing ahead with plans for eventual human testing.

The Elon Musk-led company approached Barrow Neurological Institute about partnering up to carry out studies of the implant, six people familiar with the matter told Reuters in a report published Monday.

Barrow claims to be the largest neuroscience center in the U.S. and is regularly ranked among the best neurology and neurosurgery centers in the country. Though the institute didn’t confirm Reuters’ report—nor did Neuralink—the head of its neuromodulation and neurosurgery residency program told the news wire that Barrow would be well-equipped to partner with a company like Neuralink on a brain-computer interface trial. And Reuters noted that Barrow already has plenty of experience placing implants in the brain—though those procedures have focused largely on deep-brain stimulation devices rather than interfaces linking brains with computers.

Reuters said it was unable to verify the progress of those discussions, and its sources said Neuralink has also approached other centers for potential partnerships. Neuralink did not respond to Fierce Medtech’s request for comment.

Despite those reported attempts to make arrangements for clinical trials, it’s unclear when exactly Neuralink will get the FDA’s go-ahead to actually begin such a trial.

During a “show-and-tell” event last November, Musk claimed that human trials of his company’s device could begin this spring: “Obviously, we want to be extremely careful and certain that it will work well before putting our device in a human, but we’ve submitted, I think, most of our paperwork to the FDA, and we think probably in about six months we should be able to have our first Neuralink in a human,” he said at the time, which would place that first implantation around May of this year.

But earlier this month, another Reuters report claimed that Neuralink still had quite a lot of work to do to resolve issues flagged by the FDA in its previous application to begin human trials of the device—which the agency had rejected in early 2022. Seven current and former employees weighed in on the application process, with several expressing doubt that Neuralink tie up the “dozens of issues” raised by the FDA in time to meet Musk’s latest timeline.

A company document from last fall cited in the report reportedly showed that Neuralink was expecting to receive the regulator’s clinical trial green light by March 7; now nearly three weeks past that date, the company has yet to provide any updates on the status of its trial.

The Neuralink device is meant to be placed over the brain in a robotic surgery procedure that removes part of the skull. From there, it would ideally be able to work in two directions: transmitting brain signals to a computer for translation into words and actions, and using the computer to modulate faulty brain signals.

In the November presentation, Musk said the technology will start by targeting blindness and severe paralysis and aims to help those with the latter “operate their phone faster than someone who has working hands.” Meanwhile, he said, “Even if someone has never had vision ever—like, they were born blind—we think we can still restore vision, because the visual part of the cortex is still there.”

A similar mechanism could ultimately allow Neuralink implants in both the brain and spine to help quadriplegic individuals walk again, Musk suggested, saying, “We’re confident there are no physical limitations to enabling full-body functionality.”