US-based Neuralink, a brain-computer interface startup co-founded by Elon Musk, is expecting to start its first human trial of brain implants this year.
Neuralink produces a brain implant called the Link, which intends to enable patients with severe paralysis to use neural signals to control external technologies.
During a webcast monitored by Reuters, Musk revealed that the company is planning to implant a tetraplegic or paraplegic patient.
Neuralink’s co-founder did not provide specific details about the number of patients or the duration of the trial.
The startup secured the US Food and Drug Administration (FDA) clearance in May 2023 for its first-in-human clinical trial. The FDA’s nod represented a critical milestone for the company as it is battling various US probes over handling animal experiments.
Previously, the US regulator had acknowledged in a statement to the news agency that Neuralink was permitted to conduct trials using its brain implant and surgical robot, but it chose not to provide further information.
Experts earlier told the publication that it may take several years, or possibly more than a decade, to receive commercial usage certification even if Neuralink proves the safety of its device in humans.
Additionally, the startup is competing against rival neurotech companies whose products have already been implanted in people.
In the past, Musk missed deadlines when announcing Neuralink to the public.
Founded in 2016, the brain-computer interface startup sought approval from the FDA in early 2022 but the health regulator rejected the application based on various safety concerns.
These concerns included the potential migration of implant wires within the brain, the device’s lithium battery, and the challenge of removing the device safely without damaging brain tissue.
Despite the controversies, Neuralink’s value has increased recently. The company, which was valued at around $2bn in a private financing round two years ago has increased its valuation to almost $5bn, the news agency reported earlier this month.
