Musk's brain implant company in search of human trials partner

[March 27, 2023]  By Marisa Taylor and Rachael Levy

(Reuters) - Elon Musk's brain implant company Neuralink has approached one of the biggest U.S. 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 U.S. Food and Drug Administration rejected its application to progress to human trials, citing major safety concerns, Reuters reported earlier this month.

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.

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.

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

Neuralink logo and Elon Musk photo are seen in this illustration taken, December 19, 2022. REUTERS/Dado Ruvic/Illustration/

The U.S. 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 U.S. 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 Inc 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 U.S. approval to bring a BCI implant to the market.

(Reporting by Marisa Taylor and Rachael Levy in Washington; Editing by Greg Roumeliotis and Bill Berkrot)

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