Philip O’Keefe, one of Synchron’s patients in the SWITCH clinical trial, uses his BCI.

Source: Synchron

In a Brooklyn lab filled with 3D printers and a makeshift pickleball court, employees at a startup called brain interfaces Synchronous works with technology designed to change the everyday lives of people with paralysis.

The Synchron Switch is implanted through the blood vessels to enable people with no or very limited physical mobility to use technology such as markers and smart home devices using the mind. 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 joyful and empowering to have regained an ability to be a little 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 growing brain-computer interface, or BCI, industry. A BCI is a system that deciphers the brain’s signals and translates them into commands for external technologies. Perhaps the best-known name in the space is Neuralink, thanks to the founder’s high profile Elon Muskwho is also CEO of TeslaSpaceX and Twitter.

But Musk isn’t the only tech billionaire betting on BCI’s eventual transition from radical science experiments to thriving medical business. In December, Synchron announced a $75 million funding round which included financing from the investment firms Microsoft co-founder Bill Gates and Amazon founder Jeff Bezos.

“More Scalable”

In August 2020, the Food and Drug Administration granted Synchron Groundbreaking 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 one Exceptions for investigative devices 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 into 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 spokesman said Synchron does not comment on how much the procedure will eventually cost.

While many competitors must 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.

Stentrode™ Endovascular Electrode Array.

Source: Synchron

Synchron’s BCI is fed through the blood vessels, which Oxley calls the “natural highways” into the brain. Synchron’s stent, called the Stentrode, is equipped with tiny sensors and is delivered to the large vein that sits next to the motor cortex. The stent 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 that because the device is not inserted directly into the brain tissue, the quality of the brain signal is not 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 roughly 2,000 interventionalists who can perform these procedures,” Yoo told CNBC. “It’s a little more scalable, compared to, say, open brain surgery or borehole surgery, 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 with a BCI device.

Source: Synchron

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 by 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 are text messages.

“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 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 side, with the help of BCI.

Synchron’s technology has caught the attention of competitors. Musk approached the company to discuss a potential investment last year, according to a report from Reuters. 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 on humans yet, Musk has said he hope it will 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 funding round, said that while Synchron’s device may seem like something out of science fiction, it is grounded in “real science” and is already making a significant difference in patients’ lives.

“Synchro is actually helping people starting right now, today,” he said in an interview. “It’s really exceptional for me.”

Synchron’s Brain-Computer Interface, Stentrode™ Endovascular Electrode Array and Implantable Receiver Transmitter Unit.

Source: Synchron

In January, the medical journal JAMA Neurology published the peer-reviewed, long-term safety results from a test of Synchron’s BCI system in Australia. The study found that the technology remained safe and did not degrade in signal quality or performance over a 12-month period.

“It was a huge publication for us,” Haggstrom said.

Haggstrom said commercialization is key for all players in the industry.

“I always like to be competitive, so being first to market is crucial for me,” said Haggström. “We’re meeting with future patients to talk to them about their needs and stuff, and so when you see that, and you talk to these families and caregivers, you want to race as fast as you can to help them in their daily lives.”

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