By Marisa Taylor
WASHINGTON (Reuters) – Synchron Inc., rival Elon MuskThe Neuralink brain implant startup is preparing to recruit patients for a large-scale clinical trial needed to gain commercial approval for its device, the company’s CEO told Reuters.
Synchron plans to launch an online registration for patients interested in participating in the trial on Monday, which will include dozens of participants, and has received interest from about 120 clinical trial sites to help conduct the study, CEO Thomas Oxley said in an interview.
“Part of this registry is to start getting local doctors to talk to patients with motor impairments,” he said. “There’s a lot of interest, so we don’t want it to hit a big bottleneck right before the work we’re going to do.”
New York-based Synchron is further along than Neuralink in testing its brain implant. Both companies initially aim to help paralyzed patients type on computers using devices that interpret brain signals.
Synchron received US authorization for preliminary testing in July 2021 and implanted its device in six patients. The company said previous tests on four patients in Australia showed no serious side effects.
Oxley said Synchron will analyze the U.S. data to prepare for a larger study and is awaiting approval from the U.S. Food and Drug Administration to proceed. Synchron and the FDA declined to comment on the expected timing of this decision.
Oxley said the company aims to include patients paralyzed by the neurodegenerative disease ALS (amyotrophic lateral sclerosis), stroke and multiple sclerosis.
Mount Sinai in New York, the University of Buffalo Neurosurgery, and the University of Pittsburgh Medical Center (UPMC) are collaborating on the preliminary study. Synchron said it hopes to include these centers in the larger trial.
UPMC’s Neuromuscular Division chief Dr. David Lacomis said his team was still participating in preliminary tests on humans and that the study was going well.
“Subjects continue to be monitored for safety and extensive amounts of data are collected while using the brain implant,” he said. “A much larger pivotal trial is in the planning stages.”
There are two patients in the small trial in the Department of Neurosurgery at the University at Buffalo Jacobs School of Medicine and Biomedical Sciences.
Department head Dr. “Our site has enrolled the first and only stroke patient because we think this is an important population that could benefit,” Elad Levy said. “We are optimistic and excited about the next phases of this technology.”
EXPANDING THE MARKET
Synchron and Neuralink, whose investors include billionaires Jeff Bezos and Bill Gates, compete in a field called brain-computer interface (BCI) devices. Such devices use electrodes that penetrate the brain or sit on its surface to provide direct communication with computers. No company has received final FDA approval to market the BCI brain implant.
Rather than being surgically implanted into the cerebral cortex like Neuralink’s, Synchron’s device is delivered to the brain through a large vein next to the motor cortex in the brain.
Neuralink, which mainly explains the developments regarding Musk’s social media platform X, did not respond to questions regarding its clinical trial. The company has so far announced that it has implanted its device in a paralyzed patient.
Testing an implant in paralyzed patients can be particularly challenging; because an individual’s brain may be so severely damaged that there are not enough neural signals to record.
The FDA asked Synchron to screen stroke patients using a noninvasive test to determine whether they would respond to the implant, Oxley said.
“They want to expand the market to people who have had a stroke severe enough to cause paralysis, because if it’s limited to quadriplegia, the market is too small to be sustainable,” said Kip Ludwig, former program director for neuroengineering at the U.S. National Institutes of Health. He talked about Health and Synchron.
In 2020, Synchron reported that patients in its Australian study could use its first-generation device to type an average of 16 characters per minute.
That’s better than noninvasive devices that sit on the head and record the brain’s electrical activity, helping people type up to eight characters per minute but not providing the leap forward hoped for with an implant, Ludwig said.
Oxley did not say whether the writing had accelerated or offer any other details about the ongoing trial in the US.
In May, Synchron announced it was buying a stake in medical component maker Acquandas as it plans to increase production. According to Reuters, Musk approached Synchron about a past investment.
(Reporting by Marisa Taylor; Editing by Michele Gershberg and Bill Berkrot)