Synchron Readies Large-Scale Brain Implant Trial

A brain implant startup called Synchron is preparing to recruit patients for a large-scale clinical trial to seek commercial approval for its device. Reuters reports: Synchron on Monday plans to launch an online registry for patients interested in joining the trial meant to include dozens of participants, and has received interest from about 120 clinical trial centers to help run the study, CEO Thomas Oxley said in an interview. 'Part of this registry is to start to enable local physicians to speak to patients with motor impairment,' he said. 'There's a lot of interest so we don't want it to come in a big bottleneck right before the study we'll be doing.'

Synchron received U.S. authorization for preliminary testing in July 2021 and has implanted its device in six patients. Prior testing in four patients in Australia showed no serious adverse side effects, the company has reported. Synchron will be analyzing 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 who are paralyzed due to the neurodegenerative disease ALS (amyotrophic lateral sclerosis), stroke and multiple sclerosis, Oxley said.

Synchron's device is delivered to the brain via the large vein that sits next to the motor cortex in the brain instead of being surgically implanted into the brain cortex like Neuralink's. The FDA has 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 way too small to be sustainable,' Kip Ludwig, former program director for neural engineering at the U.S. National Institutes of Health, said of Synchron. In 2020, Synchron reported that patients, opens 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 atop the head and record the electrical activity of the brain, which have helped people type up to eight characters per minute, but not the leap forward that is hoped for with an implant, Ludwig said. Oxley would not say whether typing has gotten faster or offer any other details from the ongoing U.S. trial. Reuters notes that Synchron's investors include billionaires Jeff Bezos and Bill Gates. It's competing with Elon Musk's Neuralink brain implant startup and claims it's farther along in the process of testing its device.

Earlier this year, Neuralink said it implanted a chip in its first human patient. It later said the patient fully recovered and was able to control a computer mouse using their thoughts.

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