“We are happy to announce that we’ve received approval from the reviewing independent institutional review board and our first hospital site to begin recruitment for our first-in-human clinical trial,” the Fremont-based company said in a statement posted on its corporate page.
Neuralink says that it has developed an implantable wireless BCI that was designed to be implanted into human skulls and connected by fine wires to the brain nerves. The initial goal of the BCI is to grant people the ability to control a computer cursor or keyboard using their thoughts. They suggest that this device could one day be used to treat a range of conditions such as helping quadriplegics who have a cervical spinal cord injury, or those suffering from ALS.
The goal of this trial is to evaluate the safety of the implant and surgical robot (R1 Robot) that will be used to place the implant (N1) into patients’ brains and to investigate how well the device lets people with paralysis control external devices with their thoughts. Once in place the implant should be cosmetically invisible and is intended to both record and transmit brain wave signals to an app that decodes movement intention. Recently the company raised $280 million in funding led by the San Francisco-based firm Founders Fund established by Peter Thiel.
The US FDA initially denied permission to begin human trials, citing safety concerns about parts of the implant migrating to other parts of the brain as well as possible brain damage when the device is removed. The agency granted Neurolink approval for an investigational device exemption (IDE) in May 2023 that allows the company’s devices to be used for clinical studies. The company is now actively recruiting and could begin testing on humans within 6 months.
This move follows an animal welfare violations inquiry into the company that was opened by the U.S. Department of Agriculture in December 2022 following complaints by internal staffing that the rushed testing caused the needless suffering and deaths of some 1,500 laboratory animals since 2018. Staffing also says that this number is actually higher and that this number is only a rough estimate because the company does not keep a precise record of the number of animals tested and killed, ranging from mice to monkeys.
In an unusual move, the probe was opened at the request of a federal prosecutor by the USDA Inspector General in response to growing employee dissent regarding the company’s animal testing. However, US regulations don’t specify how many animals companies can use for research and there is significant leeway given as to when and how to use animals in experiments. Remarkably, regulatory filings show that Neuralink has since all USDA inspections of its facilities.
Before the brain implants can move to the broader market, they will require regulatory approval. In 2021 the FDA released a paper mapping out the agency’s initial thoughts on brain-computer interfaces, specifically noting that the field is “progressing rapidly.”
