Synchron, rival to Musk’s Neuralink, prepares large-scale brain implant test

Synchron Inc, a rival to Elon Musk’s brain implant startup Neuralink, is preparing to recruit patients for a large-scale clinical trial needed to win commercial approval for its device, the company’s chief executive told Reuters.

Synchron plans to launch an online registry on Monday for patients interested in participating in the study, which is expected to include dozens of participants, and has received interest from about 120 clinical trial centers to help conduct the study, said the CEO Thomas Oxley in an interview.

“Part of this registry is to start allowing local doctors to talk to patients with mobility impairments,” he said. “There’s a lot of interest, so we don’t want there to be a big bottleneck right before the study we’re going to do.”

New York-based Synchron is further along in the testing process for its brain implant than Neuralink. Both companies initially intend to help paralyzed patients type on a computer using devices that interpret brain signals.

Synchron received US authorization for preliminary testing in July 2021 and has implanted its device in six patients. Previous trials on four patients in Australia showed no serious adverse side effects, the company said.

Synchron will analyze the U.S. data to prepare for the larger study while awaiting authorization from the U.S. Food and Drug Administration to proceed, Oxley said. Synchron and the FDA declined to comment on the expected timing of that decision.

The company aims to include patients paralyzed due to the neurodegenerative disease ALS (amyotrophic lateral sclerosis), stroke and multiple sclerosis, Oxley said.

Mount Sinai in New York, the University at Buffalo Neurosurgery and the University of Pittsburgh Medical Center (UPMC) are collaborating on the preliminary study. Synchron said it hopes to involve these centers in the larger study.

David Lacomis, chief of UPMC’s Neuromuscular Division, said his team is still participating in preliminary human trials “and the study is going well.”

“Individuals continue to be monitored for safety and a large amount of data is being collected as the brain implant is used,” he said. “A much larger pivotal trial is in the planning stages.”

The Department of Neurosurgery at the University at Buffalo Jacobs School of Medicine and Biomedical Sciences has two patients in the small trial.

“Our center enrolled its first and only stroke patient as we believe this is a significant population that could benefit,” said department chair Dr. Elad Levy. “We are optimistic and excited about the next phases of this technology.”

EXPANDING THE MARKET

Synchron, whose investors include billionaires Jeff Bezos and Bill Gates, and Neuralink compete in a niche of so-called brain-computer interface (BCI) devices. These devices use electrodes that penetrate the brain or sit on its surface to provide direct communication to computers. No company has received final FDA approval to market a BCI brain implant.

The Synchron device is delivered to the brain through a large vein that is close to the brain’s motor cortex, rather than being surgically implanted into the cerebral cortex like Neuralink.

Neuralink, which has primarily announced developments on Musk’s X social media platform, did not respond to questions about its clinical trial. The company has so far announced that it has implanted its device in a paralyzed patient.

Testing an implant in stroke patients can be particularly challenging because an individual’s brain may be so severely damaged that there is not enough neural signaling to register.

The FDA asked Synchron to screen stroke patients using a non-invasive test to determine whether they would respond to an implant, Oxley said.

“They want to expand the market to people who have had a stroke severe enough to cause paralysis because, if limited to quadriplegia, the market is too small to be sustainable,” said Kip Ludwig, former director of the U.S. neural engineering program. US National Institutes. of Health, said of Synchron.

In 2020, Synchron reported that patients opening a new tab in its Australian study could use its first-generation device to type an average of 16 characters per minute.

That’s better than non-invasive devices that sit on top of the head and record the brain’s electrical activity, which have helped people type up to eight characters per minute, but not the advance expected with an implant, Ludwig said.

Oxley didn’t say whether typing was faster, nor did he offer any other details of the ongoing U.S. trial.

In May, Synchron said it acquired an equity stake in medical components maker Acquandas, in an attempt to boost production. Musk has approached Synchron about an investment in the past, Reuters reported.