by By Marisa Taylor
WASHINGTON (Reuters) – Synchron Inc, a rival to Elon MuskBrain implant startup Neuralink is preparing to recruit patients for a large-scale clinical trial needed to seek commercial approval for its device, the company’s chief executive told Reuters.
Synchron plans on Monday to launch an online registry for patients interested in taking part in the multi-participant trial, and has received interest from about 120 clinical trial centers to help run the study, said CEO Thomas Oxley in an interview.
“Part of this program is to start enabling local physicians to talk to patients with motor impairments,” he said. “There’s a lot of interest so we don’t want him to get into big trouble right before the study we’re going to be doing.”
New York-based Synchron is further along in the process of testing its brain implant than Neuralink. Both companies initially aim 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 its device has been implanted in six patients. Preliminary testing in four patients in Australia showed no serious adverse side effects, the company reported.
Synchron will be analyzing the U.S. data to prepare for the larger study, pending 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 by 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 he hopes to bring these centers into the larger trial.
Dr. David Lacomis, chief of UPMC’s Division of Neuromuscular, said his team is still participating in the preliminary human testing “and the study is going well.”
“Subjects continue to be monitored for safety and an extensive amount of data is being collected as the brain implant is used,” he said. “A much larger critical trial is being planned.”
The Department of Neurosurgery at the Jacobs School of Medicine and Biomedical Sciences at the University at Buffalo has two patients in the small trial.
“The first stroke patient registered on our site, and their only stroke patient because we feel this is a significant population that could benefit from it,” said the chair of the department, Dr. Elad Levy. “We are optimistic and excited about the next steps of this technology.”
EXPANDING THE MARKET
Synchron, whose investors include billionaires Jeff Bezos and Bill Gates, and Neuralink are competing in a niche of so-called brain computer interface (BCI) devices. Such devices use electrodes that enter 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 the large vein that sits next to the motor cortex in the brain instead of being surgically implanted in the brain cortex like the Neuralink cortex.
Neuralink, which has mainly 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 they implanted their device in one paralyzed patient.
Testing an implant in stroke patients can be very challenging, as the person’s brain may be so damaged that there are insufficient neural signals to record.
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 are trying to expand the market to people who have had a stroke severe enough to cause paralysis because if it is limited to quadriplegia, the market is much too small to be sustainable,” Kip Ludwig, former director programs for neural engineering at the United States National Institutes. of Health, said 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 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 expected leap forward with an implant, Ludwig said.
Oxley would not say whether typing has become faster or offer any other data from the ongoing US trial.
In May, Synchron said it had acquired an equity stake in medical component maker Acquandas, as it looks to boost manufacturing. Musk has approached Synchron about an investment in the past, Reuters reported.
(Reporting by Marisa Taylor; Editing by Michele Gershberg and Bill Berkrot)
