Neuralink has begun looking for a partner for its human trials, ahead of the green light from the Food and Drug Administration (FDA), Reuters reports citing six people familiar with the matter.
The brain implant company, which aims to provide a cure for paralysis and blindness, is said to be in talks with Barrow Neurological Institute, a Phoenix, Arizona-based neurological disease treatment and research organization. Although the company has also discussed the possibility of partnering with other centers to carry out the complex process of testing the brain-computer interface (BCI) on its intended users.
The implant would require drilling into the brain to attach the BCI directly to the brain tissue, a novel process that has prevented the company from receiving FDA approval for testing. At least two other BCI implants using less invasive approaches have already begun human trials.
While Neuralink CEO Elon Musk announced in November that he was confident the company would begin human trials in six months, the FDA rejected the request earlier in March, citing a long list of issues. The biggest issues are safety concerns over the device’s lithium battery, the possibility of the implant’s small wires migrating to other areas of the brain, and whether or not the device could be withdrawn without injuring brain tissue.
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The status of whether Neuralink is close to addressing these issues is unclear, and the sources didn’t indicate whether Musk’s spring target for the human trials is still possible. But Francisco Ponce, director of Barrow’s Center for Neuromodulation and Neurosurgery Residency Program, told Reuters that Barrow is “well-positioned” for this clinical trial with its history in the space.
The institute helped standardize brain implant surgeries where the patient remains asleep, a crucial step in making it more acceptable to more people, Ponce added, without commenting on Neuralink.
Neuralink has some other kinks to iron out. The company is facing two probes into its practices. The Department of Agriculture is looking into whether animals suffered needless suffering and deaths during testing, while the Department of Transportation is investigating a potential mishandling of hazardous pathogens while working on animal trials with the University of California, Davis between 2018 and 2020.
Information for this briefing was found via Reuters, and the sources and companies mentioned. The author has no securities or affiliations related to the organizations discussed. Not a recommendation to buy or sell. Always do additional research and consult a professional before purchasing a security. The author holds no licenses.
