Synchron, a rival to Musk’s Neuralink, readies large-scale brain implant
trial
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[April 08, 2024]
By Marisa Taylor
WASHINGTON (Reuters) - Synchron Inc, a rival to Elon Musk's Neuralink
brain implant startup, is preparing to recruit patients for a
large-scale clinical trial required to seek commercial approval for its
device, the company's chief executive told Reuters.
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."
New-York based Synchron is farther 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 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.
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 trial.
Dr. David Lacomis, chief of UPMC's Neuromuscular Division, 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 are being collected as the brain implant is being used," he said.
"A much larger pivotal trial is in the planning stages."
The Department of Neurosurgery in the Jacobs School of Medicine and
Biomedical Sciences at the University at Buffalo has two patients in the
small trial.
"Our site has enrolled the first and only stroke patient as we feel this
is a significant population that can benefit," said department chair Dr.
Elad Levy. "We are optimistic and excited about the next phases of this
technology."
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Signage is seen at the Synchron offices in Brooklyn, New York City,
U.S., April 4, 2024. REUTERS/Andrew Kelly
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. Such 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.
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.
Neuralink, which has mainly announced developments on Musk's social
media platform X, did not respond to questions about its clinical
trial. The company has so far announced that it implanted its device
in one paralyzed patient.
Testing an implant in stroke patients can be particularly
challenging, as an individual's brain may be so severely damaged
that there isn't sufficient neural signaling to record.
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 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.
In May, Synchron said it 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)
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