Philip O’Keefe, one of Synchron’s patients in the SWITCH clinical trial, using his BCI.
In a Brooklyn lab stuffed with 3D printers and a makeshift pickleball court, employees at a brain interface startup called Synchron are working on technology designed to transform daily life for people with paralysis.
The Synchron Switch is implanted through the blood vessels to allow people with no or very limited physical mobility to operate technology such as cursors and smart home devices using their mind. So far, the nascent technology has been used on three patients in the U.S. and four in Australia.
“I’ve seen moments between patient and partner, or patient and spouse, where it’s incredibly joyful and empowering to have regained an ability to be a little bit more independent than before,” Synchron CEO Tom Oxley told CNBC in an interview. “It helps them engage in ways that 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 deciphers brain signals and translates them into commands for external technologies. Perhaps the best-known name in the space is Neuralink, thanks to the high profile of founder Elon Musk, who is also the CEO of Tesla, SpaceX and Twitter.
But Musk isn’t the only tech billionaire wagering on the eventual transition of BCI from radical science experiment to flourishing medical business. In December, Synchron announced a $75 million financing round that included funding from the investment firms of Microsoft co-founder Bill Gates and Amazon founder Jeff Bezos.
In August 2020, the Food and Drug Administration granted Synchron the Breakthrough Device designation, which is for 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 Device Exemption from the FDA to conduct trials of a permanently implantable BCI in human patients.
Synchron is enrolling patients in an early feasibility trial, which aims to show that the technology is safe to put 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 company has no revenue yet, and a spokesperson said Synchron isn’t commenting on how much the procedure will eventually cost.
While many competitors have to implant their BCIs through open-brain surgery, Synchron relies on a less invasive approach that builds on decades of existing endovascular techniques, the company said.
The Stentrode™ Endovascular Electrode Array.
Synchron’s BCI is inserted through the blood vessels, which Oxley calls the “natural highways” into the brain. Synchron’s stent, called the Stentrode, is fitted with tiny sensors and is delivered to the large vein that sits next to the motor cortex. The Stentrode is connected to an antenna that sits under the skin in the chest and collects raw brain data that it sends out of the body to external devices.
Peter Yoo, senior director of neuroscience at Synchron, said since the device is not inserted directly into the 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’s roughly about 2,000 interventionalists who can perform these procedures,” Yoo told CNBC. “It’s a little bit more scalable, compared to, say, open-brain surgery or burr holes, which only neurosurgeons can perform.”
Philip O’Keefe, one of Synchron’s patients in the SWITCH clinical trial, was the first person in the world to tweet using 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 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 often excites them the most is text messaging.
“Losing the ability to text message is incredibly isolating,” Oxley said. “Restoring the ability to text message loved ones is a very emotional restoration of power.”
In December 2021, Oxley handed over his Twitter account to a patient named Philip O’Keefe, who has ALS and struggles to move 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 approached the company to discuss a potential investment last year, according to a Reuters report. Synchron declined to comment about the report. Neuralink didn’t respond to a request for comment.
Neuralink is developing a BCI that’s designed to be inserted directly into the brain tissue, and while the company is not testing its device in humans yet, Musk has said he hopes it will do so this year.
Haggstrom said his company’s funding will help accelerate Synchron’s product development and push it toward a pivotal clinical trial that would bring the company closer to commercialization.
Khosla Ventures partner Alex Morgan, who led an earlier financing round, said that while Synchron’s device may seem like something out of science fiction, it’s grounded in “real science” and is already making a significant difference in patients’ lives.
“Synchron is actually helping people as of right now, today,” he said in an interview. “That, to me, is really exceptional.”
Synchron’s brain-computer interface, The Stentrode™ Endovascular Electrode Array and Implantable Receiver Transmitter Unit.
In January, the medical journal JAMA Neurology published the peer-reviewed, long-term safety results from a trial of Synchron’s BCI system in Australia. The study found that the technology remained safe and didn’t deteriorate in signal quality or performance over a 12-month period.
“That was a huge publication for us,” Haggstrom said.
Haggstrom said commercialization is key for all the players in the industry.
“I always like to be competitive, and so for me, being first to market is critical,” Haggstrom said. “We meet future patients to talk to about their needs and stuff, and so when you see that, and you talk to these families and the caregivers, you want to race as fast as you can to provide them assistance in their daily life.”
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