This brain-computer interface company just hit a major milestone in the US

Six weeks ago, on July 6, Peter Yoo prepared for a sleepless night.

He was in rural Victoria, Australia, but his mind was halfway across the world, awaiting the results of the first human implant of a brain-computer interface ever performed in the US.

As senior director of neuroscience and algorithms at Synchron, the Brooklyn-based tech startup behind the medical milestone, Yoo had seen four BCI devices successfully implanted in Australian patients with severe paralysis. The patients gained the ability to control digital devices via brain signals—i.e., texting loved ones, checking on their finances, and shopping online—and had no reported serious adverse effects after 12 months. Now, the FDA has approved a clinical trial in the US, with the first implantation in New York, led by Mount Sinai Hospital.

From 11pm to 4am local time, Yoo’s two golden retrievers kept him company. He stayed on a Zoom call with other members of his team, receiving updates via text. Finally, he got the news he’d been waiting for: The implantation had been successful.

With $50 million in funding—and a BCI device that requires minimally invasive brain surgery—Synchron has beaten every other BCI company, including Elon Musk’s Neuralink, to the milestone of clinical trials in the US. David Putrino, who oversaw Synchron’s clinical trial at Mount Sinai, called the technology “a quantum leap in what the field has failed to do for patients over the course of 20 to 30 years.”

“One of the reasons that we’ve not engaged in other BCI clinical trials with other invasive technologies is because we were unhappy with the fact that, of all the implanted BCI that are out there right now that have been field-tested in the last 20 years, 30 years…to my knowledge, only one of them—in one patient—over that time has translated to independent home use,” Putrino, who is director of rehabilitation innovation at Mount Sinai Health System, told us. “When we were doing our diligence on Synchron, the first four patients that had been implanted were engaging in independent home use inside of six months.”

The startup’s investors include Khosla Ventures; Max Hodak, co-founder of Neuralink; and Thomas Reardon, co-founder of Ctrl-Labs, a neural interface company that was acquired by Meta.

Decoding the brain

For Synchron’s technology to work, researchers at the company spend about three hours studying a patient’s brain anatomy and measuring how different intended movements affect their brain signals before the device is ever implanted. The parameters they develop from this process can help with accuracy.

“We're utilizing all of the information that we ever had to ever improve the decoder, and the decoder’s job is to try and translate the patient's motor intent—effective[ly] to digitize the patient's motor intent using neural signals,” Yoo said. “Part of the information that can help is the patient’s actual brain anatomy itself.”

Yoo said the company uses tools and knowledge from classical machine learning, deep learning, signal processing, electrophysiology, and neuroscience “to try to create algorithms that can translate what seems to be a noisy neural signal into controllable digital output that the patient can control by thinking.”

During the implantation procedure, a neuroendovascular proceduralist inserts the company’s Stentrode (think: medical stent plus electrodes) into a patient’s jugular vein. The device then travels up to a blood vessel that sits right next to the brain’s motor cortex, Putrino said. After the device settles, the patient should be able to begin using it to send texts to loved ones and more.

Now that safety results in Australia have been presented and the first US implantation has been completed, the next step is the safety and feasibility portion of the US clinical trial—monitoring patients to watch for adverse effects and to ensure that the device continues to deliver high-quality brain signals. That portion of the trial should take a few years, Putrino said, and if it goes well, it’ll be followed by a few more years of pivotal clinical trials, which focus on efficacy and quality-of-life improvement.

The national average for health tech to go “from bench to bedside,” or for research to be used in clinical practice, is about 17 years, according to one estimate. But Putrino said he expects a much shorter rollout for Synchron’s technology.

“Absolutely we’re going to be pushing the timeline on this—I think it is possible for these clinical trials to be done in the neighborhood of five to seven years, with the right team working to prioritize speed and pragmatic clinical trials,” he said.

Within the next six months—depending on those initial US safety results—the next implantation of Synchron’s BCI could take place, this time in Pittsburgh.

Yoo hopes to be stateside for that one.