Philip O’Keefe, one of Synchron’s patients in the SWITCH clinical trial, with his BCI.
In a Brooklyn lab crammed with 3D printers and a makeshift pickleball rig, employees at a brain-interface startup called Synchron are working on technology that promises to transform the daily lives of people living with paralysis.
The Synchron Switch is implanted through the blood vessels so that people with no or very limited physical mobility can use their minds to operate technologies such as cursors and smart home devices. So far, the nascent technology has been used on three patients in the US and four in Australia.
“I’ve seen moments between patient and partner or patient and spouse where it’s incredibly joyous and empowering to have regained the ability to be a little bit more independent than before,” Synchron CEO Tom Oxley said in an interview with CNBC. “It helps them get involved in ways we take for granted.”
Founded in 2012, Synchron is part of the burgeoning Brain Computer Interface or BCI industry. A BCI is a system that decodes brain signals and translates them into commands for external technologies. Perhaps the most well-known name in the industry is Neuralink, thanks to the high profile of founder Elon Musk, who is also the CEO of TeslaSpaceX and Twitter.
But Musk isn’t the only tech billionaire betting on BCI’s potential transition from a radical scientific experiment to a thriving medical business. In December, Synchron announced a $75 million funding round that included funding from its investment firms Microsoft Co-founder Bill Gates and Amazon Founder Jeff Bezos.
In August 2020, the Food and Drug Administration granted Synchron breakthrough device designation, which applies to medical devices that have the potential to provide improved treatment for debilitating or life-threatening conditions. The following year, Synchron became the first company to receive an investigational product exemption from the FDA to conduct trials of a permanently implantable BCI in human patients.
Synchron is enrolling patients in an early proof of concept study designed to show the technology can be safely used in humans. Six patients will be implanted with Synchron’s BCI during the study, and Chief Commercial Officer Kurt Haggstrom said the company is currently about halfway through the study.
The company has no revenue yet, and a spokesman said Synchron is not commenting on how much the process will ultimately cost.
While many competitors have to implant their BCIs through open-brain surgery, Synchron is taking a less invasive approach that builds on decades of existing endovascular techniques, the company said.
The Stentrode™ Endovascular Electrode Array.
Synchron’s BCI is introduced through blood vessels that Oxley calls the “natural highways” into the brain. Synchron’s stent, called a Stentrode, is fitted with tiny sensors and is inserted into the large vein, which is adjacent to the motor cortex. The stentrode is connected to an antenna that sits under the skin in the chest and collects raw brain data, which it sends from the body to external devices.
Peter Yoo, senior director of neuroscience at Synchron, said because the device isn’t inserted directly into brain tissue, the quality of the brain signal isn’t perfect. But the brain doesn’t like being touched by foreign objects, Yoo said, and the less invasive nature of the procedure makes it more accessible.
“There are about 2,000 interventionalists who can do these procedures,” Yoo told CNBC. “It’s a bit more scalable than, say, open-brain surgery or drill holes, which only neurosurgeons can do.”
Philip O’Keefe, one of Synchron’s patients in the SWITCH clinical trial, was the first person in the world to tweet with a BCI device.
For patients with severe paralysis or degenerative diseases such as amyotrophic lateral sclerosis or ALS, Synchron’s technology can help them regain their ability to communicate with friends, family and the outside world, whether that’s through typing, texting or even accessing social media.
Patients can use Synchron’s BCI to shop online and manage their health and finances, but Oxley said what she often gets most excited about is text messaging.
“Losing the ability to text is incredibly isolating,” Oxley said. “Restoring the ability to text loved ones is a very emotional restoration of power.”
In December 2021, Oxley donated his Twitter account to a patient named Philip O’Keefe, who has ALS and has trouble moving his hands. About 20 months earlier, O’Keefe was implanted with Synchron’s BCI.
“Hello World! Short tweet. Monumental progress,” O’Keefe tweeted on Oxley’s page using the BCI.
Synchron’s technology has caught the attention of its competitors. Musk reached out to the company last year to discuss a potential investment, according to a Reuters report. Synchron declined to comment on the report. Neuralink did not respond to a request for comment.
Neuralink is developing a BCI designed to be inserted directly into brain tissue, and while the company isn’t testing its device in humans just yet, Musk hopes to do so later this year.
Haggstrom said his company’s funding will help accelerate Synchron’s product development and advance it toward a pivotal clinical trial that would bring the company closer to commercialization.
Khosla Ventures partner Alex Morgan, who led a previous funding round, said that while Synchron’s device might seem like something straight out of science fiction, it’s based on “real science” and is already making significant changes to patients’ lives.
“Synchron is already helping people today,” he said in an interview. “It’s really extraordinary for me.”
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Synchron’s brain-computer interface, the Stentrode™ endovascular electrode array, and the implantable receiver-transmitter unit.
In January, the medical journal JAMA Neurology published the peer-reviewed long-term safety results of a study of Synchron’s BCI system in Australia. The study found that the technology remained safe over a 12-month period, with no degradation in signal quality or performance.
“This was a huge release for us,” Haggstrom said.
Haggstrom said commercialization is key for all industry players.
“I always like to be competitive, so being first to market is crucial for me,” Haggstrom said. “We meet future patients to talk to them about their needs and things and when you see that and talk to these families and the caregivers, you want to start racing as soon as possible to help them in their daily lives.”
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