A partner for human trials is sought by Musk’s brain implant business.
27 March 2023 (Reuters) According to six sources with knowledge of the situation, Elon Musk’s brain implant business Neuralink has approached one of the largest U.S. neurosurgical clinics as a possible clinical trials partner as it gets ready to test its devices on humans if regulators permit it.
Since 2016, Neuralink has been working on brain implants that it thinks may one day treat incurable diseases including paralysis and blindness.
Early in 2022, the U.S. Food and Drug Administration denied its proposal to go to human trials, citing serious safety concerns, according to Reuters earlier this month. This dealt it a setback.
Since then, the corporation has been attempting to allay the agency’s worries, although it is uncertain whether and when this will be effective.
According to the sources, Neuralink has been in contact with Barrow Neurological Institute, a center for the treatment and study of neurological disorders with offices in Phoenix, Arizona, to assist with the execution of the human trials.
According to sources who requested anonymity to discuss confidential deliberations, Neuralink is in talks with the Barrow Neurological Institute in Phoenix, Arizona, about potentially partnering on clinical trials for its brain implants. However, it is uncertain if the discussions will lead to a team-up, as Neuralink has also been exploring other potential partners.
The current status of the talks could not be independently verified by Reuters, and representatives from Neuralink did not respond to requests for comment. Francisco Ponce, the director of Barrow’s Center for Neuromodulation and Neurosurgery Residency Program, declined to comment on the potential partnership but noted that the institute is well-suited for implant research given its extensive experience in the field.
The US Food and Drug Administration declined to comment on Neuralink’s search for a clinical trials partner.
These latest efforts by Neuralink come amid ongoing scrutiny, as the company faces two known federal investigations in the US. The Department of Agriculture’s Inspector General is reportedly investigating potential animal welfare violations at Neuralink, with some current and former employees alleging that the company’s animal experiments were rushed and resulted in unnecessary suffering and deaths.
The U.S. Department of Transportation is investigating potential mishandling of hazardous pathogens during a partnership between a company and the University of California, Davis from 2018 to 2020, which involved animal trials.
According to Ponce, Barrow has helped make brain implant surgeries more acceptable to a broad set of the population by standardizing the procedure, allowing patients to remain asleep. This is aligned with Musk’s vision for Neuralink’s brain chip, with the aim of making brain implants as ubiquitous as Lasik eye surgery. However, the deep brain stimulation devices that Barrow works with differ from Neuralink’s brain computer interface (BCI) device, which uses electrodes to provide direct communication to computers. While more than 175,000 patients have received FDA-approved deep brain stimulation devices to help reduce Parkinson’s tremors, no company has received approval to bring a BCI implant to the market in the United States.
