Brain implant company Synchron has paused clinical trials of its second-generation device after it failed to perform as expected in initial study participants, WIRED has learned.
The Brooklyn-based startup, a competitor to Elon Musk’s Neuralink, is also undergoing a restructuring, which includes eliminating jobs and scaling back its footprint in New York while building up a team in San Diego to support the development of an entirely new device.
Synchron is one of several companies developing brain-computer interface technology meant to allow people to control digital devices by reading brain signals and translating those signals into output commands. The company has touted its technology, dubbed the Stentrode, as minimally invasive since it does not rest in the brain itself or require brain surgery.
Instead, the stent-like mesh tube is inserted into the jugular vein at the base of the neck, then guided with a catheter to sit on top of the brain’s motor cortex. The company’s first-generation Stentrode connected using an external wire resting on a user’s chest. Ten volunteers across the US and Australia received that device and were able to send emails, text, browse the internet, and do online shopping and banking with their thoughts. Synchron has also enabled volunteers to control an Amazon Alexa and Apple’s iPad and Vision Pro without using their hands or voice.
Synchron’s second-generation device has fewer electrodes and is fully wireless, using Bluetooth to connect. The company launched a multisite trial in the US earlier this spring with sister sites in Australia and Canada to evaluate the newer Stentrode, and some participants have already had it implanted. Those sites have recently paused enrollment, however, because the device is not working as intended, according to sources familiar with the trials who asked to remain anonymous.
In a statement to WIRED, Synchron says it voluntarily paused enrollment “after identifying a performance issue involving the lead, the cable that carries signals from the Stentrode to the implanted electronics.”
“The issue does not involve the Stentrode itself and no safety issues related to the device have been identified. The pause was a company decision, not an FDA-directed action,” the statement continues.
The company says it has since brought lead design and manufacturing in-house. Instead of fixing the lead alone, Synchron says it is upgrading the whole Stentrode system and will resume trial enrollment once the hardware upgrades are complete.