Philip O’Keefe, one of Synchron’s patients in the SWITCH clinical trial, using his BCI.
In a Brooklyn lab complete with 3D printers and a makeshift pickleball court, employees of a brain interface startup called Synchron are working on technology designed to transform the daily lives of people with paralysis.
The synchronous switch is implanted through blood vessels to allow people with no or very limited physical mobility to control technology such as cursors and smart home devices using their minds. So far, the nascent technology has been used on three patients in the US and four in Australia.
“I’ve seen moments between a patient and a partner, or a patient and a spouse, where it’s incredibly joyful and empowering to regain the 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 burgeoning brain-computer interface, or BCI, industry. A BCI is a system that deciphers brain signals and translates them into commands for external technology. 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 TeslaSpaceX and Twitter.
But Musk isn’t the only tech billionaire betting on BCI’s eventual transition from a radical science experiment to a booming medical business. In December, Synchron announced a $75 million funding 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 A 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 research device clearance from the FDA to conduct human trials of a permanently implantable BCI.
Synchron is enrolling patients in an early feasibility trial that aims to show the technology is safe for use in humans. Six patients will be implanted with Synchron’s BCI during the study, and Chief Commercial Officer Kurt Hagstrom said the company is currently at the halfway point.
The company does not yet have revenue, and a spokesman said Synchron would not comment on how much the procedure would ultimately cost.
While many competitors must implant their BCIs through open brain surgery, Synchron relies on a less invasive approach that builds on decades-old endovascular techniques, the company said.
The Stentrode™ Endovascular Electrode Array.
Synchron’s BCI is inserted through blood vessels, which Oxley calls “natural highways” in the brain. Synchron’s stent, called the Stentrode, is equipped with tiny sensors and is delivered to a large vein that is 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 from the body to external devices.
Peter Yu, senior director of neurology 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, Yu said, and the less invasive nature of the procedure makes it more affordable.
“There are approximately 2,000 or so interventionalists who can perform these procedures,” Yu told CNBC. “It’s a little bit more scalable compared to, say, open brain or hole surgery, 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 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 the ability to communicate with friends, family and the outside world, whether through writing, 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 worries them most is texting.
“Losing the ability to text is incredibly isolating,” Oxley said. “Regaining the ability to text loved ones is a very emotional re-empowerment.”
In December 2021, Oxley handed over his Twitter account to a patient named Philip O’Keefe, who has ALS and struggles to move his arms. About 20 months earlier, O’Keefe had been implanted with a Synchron BCI.
“Hello world! Short tweet. Monumental progress,” O’Keefe tweeted on Oxley’s page using BCI.
Synchron’s technology 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 on the report. Neuralink did not respond to a request for comment.
Neuralink is developing a BCI that is designed to be inserted directly into brain tissue, and while the company has yet to test its device in humans, Musk said he hopes to do so this year.
Haggstrom said his company’s funding will help accelerate development of Synchron’s product and push it toward a pivotal clinical trial that will bring the company closer to commercialization.
Khosla Ventures partner Alex Morgan, who led an earlier round of funding, said that while Synchron’s device may seem like something out of science fiction, it is based on “real science” and is already making a significant difference in patients’ lives .
“Synchron is actually helping people right now, today,” he said in an interview. “That to me is really extraordinary.”
Synchron brain-computer interface, Stentrode™ endovascular electrode array, and implantable transmitter-receiver module.
In January, the medical journal JAMA Neurology published 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 did not degrade signal quality or performance over a 12-month period.
“This was a huge post for us,” Hagstrom said.
Haggstrom said commercialization is key for all industry players.
“I always like to be competitive, so it’s critical for me to be first to market,” Hagstrom said. “We’re meeting with prospective patients to talk to them about their needs and stuff, and so when you see that and you talk to those families and caregivers, you want to race as fast as you can to get them help in their daily lives .”
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