SAN FRANCISCO and NEW YORK CITY and MELBOURNE, Australia, Sept. 20 2019 /PRNewswire/ -- Synchron Inc.
today announced the first successful clinical implantation of the
Stentrode®, a minimally-invasive neural interface
technology, a component of the Synchron Brain-Computer Interface.
This is the first clinical feasibility trial evaluating this
technology for its potential to restore communication in people
with severe paralysis.
The Stentrode is the only investigational implantable device
that does not require open brain surgery and is designed to record
brain activity and stream thoughts wirelessly directly from the
brain.
The technology relies on a revolutionary brain-controlled
handsfree app platform called brainOS™ to
translate the brain activity into a standardized digital language
to control apps that restore communication and limb function. In
addition, brainPort™, a fully-internalized,
wireless solution implanted in the chest provides high-resolution
neural data transmission, and is the final component of the
Synchron Brain-Computer Interface.
"The commencement of human trials of a commercial brain computer
interface is a major milestone for the industry. By using veins as
a naturally-existing highway into the brain, we have been able to
reach the clinical stage significantly earlier than other more
invasive approaches," said Thomas
Oxley, MD, PhD, CEO of Synchron.
The trial of the Stentrode in combination with
brainOS software will evaluate the safety, as well as assess
the stability of high-fidelity signals acquired from the brain to
control external communications technologies. The trial is
being conducted in Melbourne,
Australia and will include patients with loss of motor
function from paralysis due to a range of conditions including
spinal cord injury, stroke, muscular dystrophy, or motor neuron
disease (ALS) patients.
Pre-clinical studies have demonstrated the Stentrode's long-term
safety as well its ability to pick up specific electrical
frequencies emitted by the brain. Synchron, in collaboration
with the University of Melbourne, has
published their scientific results in top ranking journals
including Nature Biotechnology, Nature Biomedical Engineering and
the Journal of Neurosurgery.
Similar to the procedure utilized for implantation of cardiac
pacemakers, implantation of the Stentrode is a minimally-invasive
procedure during which the device is delivered to the brain through
blood vessels. As the Stentrode system is small and flexible enough
to safely pass through curving blood vessels, insertion of the
device does not require open brain surgery. This may reduce risk of
brain tissue rejection of the device, which has been a significant
problem for other techniques. Other neural interface devices,
such as those being developed by Bryan
Johnson's Kernel, Elon Musk's
Neuralink and BrainGate, currently require drilling open the skull
and direct puncture into the brain to achieve device
implantation.
"By reimagining the concept of the operating system, we have
designed our technology platform to enable a completely hands-free
user experience. What we learn from the first-in-human clinical
trial will be highly valuable in guiding our device design and
clinical protocol for a pivotal trial in the U.S.," said Oxley.
The Stentrode utilizes brainOS, a modular training software that
enables patients to control assistive technologies directly through
thought. The brainOS platform is a suite of brain-controlled
apps that aims to enable patients to restore lost speech and limb
function. While current computer operating systems require pressing
or tapping at least one button, typically on a mouse or a keyboard,
brainOS offers handsfree control. The platform is designed to
re-define the user experience for the large number of people who
have trouble using a mouse or keyboards.
Ultimately this system holds promise to enable superior control
of complex technology for humans not achievable by use of the
muscles in bodies.
Synchron is in discussions with the FDA over its regulatory
strategy, and the FDA has contributed to the planning for the
first-in-human trial as a preliminary step on an approval pathway.
The safety and efficacy data from these first participants will be
used to finalize the protocol for a pivotal FDA-enabling study that
will guide evaluation for U.S. marketing approval.
"Our bodies can only carry so much information out of the brain.
This industry is going to unlock the brain's computational power in
ways that are hard to imagine now. This is just the beginning,"
said Oxley.
About Brain Computer Interfaces
Neural interface
technology, also known as brain–computer interfaces (BCI) or
brain-machine interfaces (BMI), are devices that utilize artificial
intelligence to enable people to directly interact with computers
through thought alone. The technology holds promise not only for
patients with severe paralysis who would like to regain the ability
to speak. In addition, it may give these patients the ability to
control external devices that restore limb function such as
functional electrical stimulation (FES), wearable exoskeletons and
robotic limbs.
According to a McKinsey Global Institute report released in
2013, there are 50 million people with impaired mobility or
amputations living in advanced economies. The report, estimates
that robotic human augmentation applications are positioned to
result in an economic impact of 0.6-2.0
trillion dollars annually by 2025.
In February 2019 the FDA released
a guidance document on brain computer interfaces, recognizing the
"potential to bring benefit to people with severe disabilities by
increasing their ability to interact with their environment, and
consequently, providing new independence in daily life." The
document outlines considerations for preclinical and clinical
testing for this rapidly emerging field. Synchron has been in
discussion with the FDA since 2017.
About Synchron, Inc.
Based in Campbell,
California and Melbourne, Australia, Synchron,
Inc. is a pioneering technology company building
next-generation neuromodulation solutions. Synchron is developing
the world's first endovascular neural interface, the
Stentrode™.
Development of this technology platform has been funded in part
by grants from the U.S. Defense Advanced Research Projects Agency
(DARPA) and U.S. Department of Defense (DoD). The technology was
lauded by then President Barack
Obama as highly promising in a public statement.
NeuroTechnology Investors subsequently led a Series A round of
financing that included METIS innovative.
The company, which was spun out of the University of Melbourne, is targeting paralysis due
to a range of neurological conditions as a first application.
Synchron recently reported on the ability to deliver endovascular
neuromodulation stimulation into the brain and are investigating
alternative therapeutic applications in Movement Disorders, Stroke
and Epilepsy.
Stentrode, BrainOS, brainPort, BrainClick and Thought-to-Text
are trademarks of Synchron, Inc.
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SOURCE Synchron Inc.
