Hermes Vector

Health

Synchron Pauses Trials of Second-Generation Brain Implant Over Lead Issue

Synchron has voluntarily paused enrollment in trials of its wireless second-generation Stentrode after identifying a performance issue with the lead, the cable that carries signals from the implant to the electronics.

By Hermes Vector

Also in: Español · Português · Français · Deutsch · हिन्दी

Checked against 3 sourceswired.commlq.aistartupfortune.com
Illustration for: Synchron Pauses Trials of Second-Generation Brain Implant Over Lead Issue

In brief

  • Synchron paused enrollment in trials of its second-generation Stentrode after a performance issue with the lead.
  • The company says there are no safety issues and the FDA did not order the pause.
  • Synchron is upgrading the whole Stentrode system and will resume enrollment once hardware upgrades are complete.
  • The company is restructuring, cutting jobs in New York and hiring engineers in San Diego.

Synchron Pauses Trials of Second-Generation Brain Implant Over Lead Issue

Synchron has paused enrollment in clinical trials of its second-generation Stentrode brain implant after the device failed to perform as expected in initial study participants, WIRED reported on November 12, 2026.

The Brooklyn-based startup said 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," Synchron said in a statement to WIRED.

The company has brought lead design and manufacturing in-house and is upgrading the whole Stentrode system rather than fixing the lead alone. Synchron said it will resume trial enrollment once the hardware upgrades are complete.

Trial Status

Synchron launched a multisite trial in the US earlier this spring with sister sites in Australia and Canada to evaluate the newer Stentrode. The US early feasibility study, called INTENT, planned to enroll about 10 people at five sites: Mayo Clinic in Jacksonville, the University at Buffalo, Mount Sinai in New York, UPMC in Pittsburgh and UT Southwestern in Dallas. Its registry entry, updated Nov. 5, lists it as active but not recruiting. The Australian FOCUS study, also planned for 10 people, switched to the same status on Nov. 6. The Canadian FOCUS study at two Toronto hospitals was marked terminated for "insufficient recruitment" the same day, after enrolling one participant. Two of the five US trial sites that WIRED was able to reach confirmed that recruitment is on hold at those locations.

Restructuring and Future Device

Synchron is undergoing a restructuring that 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’s website and LinkedIn page show around a dozen job openings in San Diego, including electrical and mechanical engineers, microchip designers, and materials scientists. The San Diego team will be designing and manufacturing the upgraded lead and Stentrode, as well as a separate device that the company has not yet revealed that will go "beyond the blood vessels altogether," according to its website.

Synchron CEO Tom Oxley said the company still has "strong confidence that it has the potential to be a first-line therapy." The company also said it will continue to support participants with Stentrode devices across their lifetime.

Why it matters

These trials are key to Synchron advancing the Stentrode into a larger pivotal trial, which is needed for the US Food and Drug Administration to grant marketing approval. Synchron was estimated to have a nearly $1 billion valuation after closing a $200 million funding round last fall. It is backed by Khosla Ventures and the venture firms of Bill Gates and Jeff Bezos.

Sources

This article was drafted with AI assistance and checked against the sources above. Company claims are reported as claims. Cover image is AI-generated.

Questions readers ask

Why did Synchron pause its clinical trials?
Synchron paused enrollment in its second-generation Stentrode brain implant trials after identifying a performance issue involving the lead, which is the cable that carries signals from the device to the implanted electronics.
What is the current status of the INTENT, FOCUS, and Canadian FOCUS trials?
The US INTENT study and the Australian FOCUS study are listed as active but not recruiting, while the Canadian FOCUS study was marked terminated for insufficient recruitment after enrolling one participant.
Is the pause in trials a requirement from the FDA?
No, the pause was a company decision and not an FDA-directed action, as no safety issues related to the Stentrode itself have been identified.
Where is Synchron building its new team for device development?
Synchron is scaling back its New York footprint and building up a team in San Diego to design and manufacture the upgraded lead and Stentrode.
Why are these trials important for Synchron?
The trials are key to advancing the Stentrode into a larger pivotal trial, which is needed for the US Food and Drug Administration to grant marketing approval.

The day's checked news, by email

One short email a day with the top stories. Free, and you can unsubscribe in one click.

Or follow for the latest news:

How do you feel about this story?

Comments 0

No comments yet. Start the discussion.

More Health stories