Neuralink Said to Approach US Neurosurgery Centre as Potential Human Clinical Trials Partner

Neuralink is working to address concerns expressed by the US Food and Drug Administration after it rejected an application for human trials in 2022.

By Reuters | Updated: 27 March 2023 18:48 IST

Neuralink Said to Approach US Neurosurgery Centre as Potential Human Clinical Trials Partner

Photo Credit: Reuters

Neuralink has been developing brain implants since 2016

Highlights

FDA rejected its application to progress to human trials in early 2022
Neuralink currently faces two known US federal probes into its practice
Neuralink's implant is a brain computer interface (BCI) device

Elon Musk's brain implant company Neuralink has approached one of the biggest US neurosurgery centers as a potential clinical trials partner as it prepares to test its devices on humans once regulators allow for it, according to six people familiar with the matter.

Neuralink has been developing brain implants since 2016 it hopes will eventually be a cure for intractable conditions such as paralysis and blindness.

It suffered a blow in early 2022, when the US Food and Drug Administration rejected its application to progress to human trials, citing major safety concerns, Reuters reported earlier this month.

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The company has since been working to address the agency's concerns, and it is unclear if and when it will be successful.

Neuralink has been talking to Barrow Neurological Institute, a Phoenix, Arizona-based neurological disease treatment and research organization, to help carry out the human trials, the sources said.

The talks may not result in a team-up. Neuralink has also discussed partnering with other centers, added the sources, who requested anonymity to discuss the confidential deliberations.

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Reuters could not verify the latest status of the talks. Neuralink representatives did not respond to requests for comment.

Francisco Ponce, director of Barrow's Center for Neuromodulation and Neurosurgery Residency Program, declined to comment on Neuralink but said Barrow was well-positioned to conduct such implant research because of its long track record in the field.

The FDA declined to comment on Neuralink's efforts to find a partner for its clinical trials.

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Neuralink's latest efforts come as it faces two known US federal probes into its practices.

The US Department of Agriculture's Inspector General began looking into potential animal-welfare violations at Neuralink last year. Current and former employees have detailed concerns to Reuters about the company's rushed animal experiments, resulting in needless suffering and deaths.

The US Department of Transportation has said it is investigating the potential mishandling of hazardous pathogens during the company's partnership on animal trials with University of California, Davis between 2018 and 2020.

Barrow has helped standardize brain implant surgeries in which the patient can remain asleep, a key step in making it more acceptable to a broad set of the population, Ponce said.

This is in line with Musk's vision for Neuralink's brain chip. The billionaire CEO of Tesla and majority owner of Twitter has said Neuralink's brain implants will become as ubiquitous as Lasik eye surgery.

The devices Barrow has been implanting so far are different than Neuralink's. Barrow works with deep brain stimulation devices, which received FDA approval in 1997 to help reduce Parkinson's tremors and have been implanted in more than 175,000 patients.

Neuralink's implant is a brain computer interface (BCI) device, which uses electrodes that penetrate the brain or sit on its surface to provide direct communication to computers. So far, no company has received US approval to bring a BCI implant to the market.

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