For people with paralysis hoping for a place in Synchron’s trials, the wait has just got longer. The company has paused enrolment in trials of its second-generation device after it did not perform as expected in early participants, WIRED reported on 12 November.
What happened
Synchron said it paused enrolment voluntarily “after identifying a performance issue involving the lead, the cable that carries signals from the Stentrode to the implanted electronics.” In its statement, the company said the problem does not involve the Stentrode itself, that no safety issues related to the device have been found, and that the FDA did not direct the pause.
Synchron says it has brought design and manufacturing of the lead in-house. It is upgrading the whole Stentrode system and will resume enrolment once that work is finished. It has not given a date. “We will continue to support participants with Stentrode devices across their lifetime,” the company said.
“We still have strong confidence that it has the potential to be a first-line therapy,” chief executive Tom Oxley said of the Stentrode.
The trials affected
The updated Stentrode has fewer electrodes than the first and is fully wireless, connecting over Bluetooth. The first-generation device used an external wire on the chest and went into ten volunteers in the US and Australia. In March, Oxley told the Herald Sun the new version could recognise up to 16 different commands.
Three Synchron studies started this year, and their timing and sites match the trials WIRED describes:
- INTENT in the US began on 7 May, aiming to enrol 10 people. It lists five sites: Mayo Clinic in Jacksonville, the University at Buffalo, Mount Sinai in New York, UPMC in Pittsburgh and UT Southwestern in Dallas.
- FOCUS-AUS began on 22 May at the Royal Melbourne Hospital, also aiming to enrol 10 people.
- FOCUS-CAN began on 18 March at two Toronto hospitals. Its entry lists it as terminated, with a completion date of 25 September, and gives the reason as insufficient recruitment. It records one participant enrolled. Synchron has not said whether the termination is linked to the lead problem.
The US and Australian entries, last updated on 5 and 6 November, list both studies as active but not recruiting. WIRED, citing people familiar with the trials, reported that the US, Australian and Canadian sites had recently paused enrolment. Two of the five US trial sites that WIRED was able to reach confirmed that recruitment is on hold. A coordinator at one said the pause was about making sure Synchron gets the readouts it wants from the device, and was unrelated to safety.
The restructuring
WIRED also reported that Synchron is restructuring: cutting jobs and scaling back in New York while building a team in San Diego. The San Diego team will design and manufacture the upgraded lead and Stentrode, and a separate device that WIRED said the company’s website described as going “beyond the blood vessels altogether”.
Synchron’s careers page, checked on 13 November, lists 13 open roles in San Diego, among them a manufacturing technician for lead assembly, and none in New York. The page describes the next system as reaching “all regions of the brain through a catheter, not a hole in the skull”, covering multiple brain regions at once and “putting active electronics on the brain itself”. It describes the Stentrode as the company’s first product.
The cuts come a year after Synchron raised its US$200 million Series D in November 2025, led by Double Point Ventures, and said it would expand a Cognitive AI division in New York and had set up a San Diego engineering hub. That round was meant to fund pivotal trials and preparation for commercial launch. WIRED reported an estimated valuation of nearly US$1 billion after the raise.
Signal: Why it matters
Synchron’s pitch has rested on avoiding brain surgery: the Stentrode is threaded through the jugular vein to sit in a blood vessel on top of the motor cortex. The early studies, now closed to new participants, are the step before a larger pivotal trial, which the FDA needs before it can approve the device for sale, so the pause is likely to push that step back. Synchron has not said whether its pivotal plans change.
The pause also delays the Australian trial in which, Oxley told the Herald Sun in March, participants would be able to wake and unlock Apple devices by thought. In May 2025 Synchron announced it would be the first brain-computer interface company to integrate natively with Apple’s new protocol for iPhone, iPad and Vision Pro, and its November 2025 funding release said it had co-developed the Bluetooth-based protocol. InsideBCI has found no other brain-computer interface company that has publicly said it uses the protocol.
Not disclosed
How many people have received the updated device has not been made public. WIRED says some participants already have it, and the Canadian entry records one participant enrolled. Synchron has not said what the performance problem does to the signal, how many jobs are being cut or when enrolment will restart, and it has not named or shown its new device.
Forward Radar: What to watch
When enrolment restarts, and whether the US and Australian registry entries change.
Whether the timing of Synchron’s pivotal trial moves.
What the San Diego device turns out to be, and whether other brain-computer interface makers say they use Apple’s protocol.
Sources
Primary:
- WIRED: Synchron pauses trials of its brain implant due to performance issues, 12 November 2026
- ClinicalTrials.gov: INTENT early feasibility study (NCT07543367)
- ClinicalTrials.gov: FOCUS-AUS (NCT07533903)
- ClinicalTrials.gov: FOCUS-CAN (NCT07446114)
- Synchron: careers page
- Synchron via Business Wire: Synchron raises US$200 million Series D, 6 November 2025
- Synchron via Business Wire: first native BCI integration with iPhone, iPad and Apple Vision Pro, 13 May 2025
Cross-reference to prior InsideBCI coverage: