Synchron pauses trials of second-generation brain implant, says issue is not safety-related

Mixed · 2Synchron, a Brooklyn-based brain-computer interface startup, has paused enrollment in clinical trials of its second-generation Stentrode implant. 1 2 Left · 1Wired, citing anonymous sources familiar with the trials, reported that the device was not working as intended; Synchron told Wired it voluntarily paused enrollment after identifying a performance issue involving the lead, the cable that carries signals from the Stentrode to the implanted electronics. 1 Mixed · 2The company said the issue does not involve the Stentrode itself, that no device safety issues have been identified, and that the pause was a company decision, not an FDA-directed action. 1 2

Left · 1Synchron says it has brought lead design and manufacturing in-house, and rather than fixing the lead alone it is upgrading the whole Stentrode system and will resume enrollment once the hardware upgrades are complete. 1 Left · 1Two of the five US trial sites Wired could reach confirmed recruitment is on hold; a coordinator at one said the pause was not safety-related and was because Synchron was checking that the device delivers the readouts it wants. 1 Left · 1The second-generation device has fewer electrodes and is fully wireless via Bluetooth; the multisite US trial, with sister sites in Australia and Canada, began this spring and some participants have already been implanted. Synchron says it will keep supporting participants with Stentrode devices across their lifetime. 1

Left · 1The trials are a step toward a larger pivotal trial needed for FDA marketing approval, and CEO Tom Oxley said the company still has strong confidence the Stentrode could be a first-line therapy. 1 Mixed · 2Synchron is also restructuring: it is eliminating jobs and scaling back in New York while building a San Diego team to design and manufacture the upgraded lead and Stentrode and a separate, not yet revealed device. 1 2 Centre · 1STAT called it the first major hiccup for Synchron and linked it to a comment Oxley made on a New York panel last week, that "it just takes a delayed one to slow down your submission to the FDA" and that the company was caught up on one particular component. 2

Left · 1The first-generation Stentrode, which used an external wire on the chest, was implanted in ten volunteers in the US and Australia, who used it to send emails, browse and bank online with their thoughts. Synchron, valued at nearly $1 billion after a $200 million round last fall, is backed by Khosla Ventures and the venture firms of Bill Gates and Jeff Bezos. 1