Country for PR: United States
Contributor: PR Newswire New York
Thursday, June 25 2020 - 13:06
AsiaNet
AUD$1.5M NHMRC Awards Grant to Expand Feasibility Trials for Stentrode, the First Interventional Neuromodulation Platform
SAN FRANCISCO and NEW YORK and MELBOURNE, June 25, 2020 /PRNewswire-AsiaNet/ --

-- Synchron's Stentrode brain-computer interface system is a fully-implantable 
therapeutic being evaluated for its safety and efficacy to restore functional 
independence via hands-free control of electronic devices in patients with 
upper limb paralysis 

Synchron Inc.( 
https://c212.net/c/link/?t=0&l=en&o=2841110-1&h=3687341068&u=https%3A%2F%2Fwww.synchronmed.com%2Fabout%2F&a=Synchron+Inc. 
), a neurovascular bioelectronic medicine company, today announced that the 
University of Melbourne has been awarded an AUD$1.5M Medical Research Future 
Fund( 
https://c212.net/c/link/?t=0&l=en&o=2841110-1&h=603765233&u=https%3A%2F%2Fwww.health.gov.au%2Finitiatives-and-programs%2Fmedical-research-future-fund&a=Medical+Research+Future+Fund 
) grant from the National Health and Medical Research Council (NHMRC) of the 
Australian Government to expand the current clinical study of Synchron's 
Stentrode(R)( 
https://c212.net/c/link/?t=0&l=en&o=2841110-1&h=1571069589&u=https%3A%2F%2Fwww.synchronmed.com%2Fstentrode%2F&a=Synchron%27s+Stentrode%C2%AE 
). The study is the first clinical trial to evaluate the safety and efficacy of 
the Stentrode, the first interventional neuromodulation platform. This 
technology is designed to translate brain activity from the inside of a blood 
vessel, and is being explored for its potential to enable hands-free control of 
devices for people with upper limb paralysis.

"Having this support from the Australian government further validates the 
importance of our work and our confidence that this technology will lead to the 
realization of a treatment option with the capability to transform the lives of 
patients with paralysis," said Thomas Oxley, MD, PhD( 
https://c212.net/c/link/?t=0&l=en&o=2841110-1&h=3913799485&u=https%3A%2F%2Fwww.youtube.com%2Fwatch%3Fv%3DmmiIz6ZJfq0&a=Thomas+Oxley%2C+MD%2C+PhD%2C 
), CEO of Synchron. "The potential to advance this important work that this 
grant offers cannot be understated."

The funds will be used to expand the current feasibility study to include:

 -- additional patient participants. 
 -- patient participants that experience paralysis due to conditions beyond 
motor neuron disease, also known as amyotrophic lateral sclerosis (ALS). These 
conditions may include stroke, spinal cord injury and muscular dystrophy. 
 -- additional trial sites. While the trial is currently being conducted at the 
University of Melbourne, the study will be expanded to Royal Prince Alfred 
Hospital in Sydney and Royal Brisbane and Women's Hospital in Brisbane

The safety and efficacy data from these first participants will be used to 
finalize the protocol for a pivotal FDA-enabling study, intended to support 
U.S. marketing approval. Synchron continues to engage in discussions with the 
FDA over its regulatory strategy, and the FDA's guidance has contributed to the 
planning for Synchron's first-in-human trial as a preliminary step on an 
approval pathway. 

In December, the company announced the first successful clinical implantation( 
https://c212.net/c/link/?t=0&l=en&o=2841110-1&h=3021201916&u=https%3A%2F%2Fwww.prnewswire.com%2Fnews-releases%2Fsynchron-achieves-first-successful-human-implantation-of-brain-computer-interface-300922195.html&a=first+successful+clinical+implantation 
) of the Stentrode. 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 preclinical results in top-ranking journals 
including Nature Biotechnology( 
https://c212.net/c/link/?t=0&l=en&o=2841110-1&h=464017205&u=https%3A%2F%2Fwww.nature.com%2Farticles%2Fnbt.3428&a=Nature+Biotechnology 
), Nature Biomedical Engineering( 
https://c212.net/c/link/?t=0&l=en&o=2841110-1&h=1081447972&u=https%3A%2F%2Fwww.nature.com%2Farticles%2Fs41551-018-0321-z%3Futm_source%3Dfacebook%26utm_medium%3Dsocial%26utm_content%3Dorganic%26utm_campaign%3DNJPN_2_KI_natbiomedeng_jpn_dec2018issue&a=Nature+Biomedical+Engineering 
) and the Journal of Neurosurgery( 
https://c212.net/c/link/?t=0&l=en&o=2841110-1&h=2220013270&u=https%3A%2F%2Fthejns.org%2Fview%2Fjournals%2Fj-neurosurg%2F128%2F4%2Farticle-p1020.xml&a=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 Stentrode does not require open brain surgery. Other 
neural interface devices, such as those being developed by Elon Musk's 
Neuralink( 
https://c212.net/c/link/?t=0&l=en&o=2841110-1&h=796378452&u=https%3A%2F%2Fwww.bloomberg.com%2Fnews%2Farticles%2F2019-07-17%2Felon-musk-s-neuralink-says-it-s-ready-to-begin-brain-surgery&a=Elon+Musk%27s+Neuralink 
) and BrainGate( 
https://c212.net/c/link/?t=0&l=en&o=2841110-1&h=2697915866&u=https%3A%2F%2Fspectrum.ieee.org%2Fthe-human-os%2Fbiomedical%2Fdevices%2Fparalyzed-individuals-operate-tablet-with-brain-implant&a=BrainGate 
), currently require drilling open the skull and a direct puncture into the 
brain to achieve device implantation.

About Stentrode
The only interventional neuromodulation platform, Stentrode(TM) is designed to 
function as both a neuroprosthesis and neuromodulation device. The tiny 
Stentrode motor neuroprosthesis is implanted next to the brain's motor cortex 
and interacts with the nervous system from inside a blood vessel to translate 
brain commands. The Stentrode brain-computer interface system is undergoing 
clinical investigation to evaluate its ability to improve functional 
independence for people with paralysis by restoring command control of external 
devices that facilitate instrumental activities of daily living. Future 
interventional neuromodulation applications may include the potential to 
diagnose and treat nervous system conditions, including Parkinson's disease, 
epilepsy, depression, and hypertension. 

About Synchron, Inc.
Synchron, Inc. is a clinical-stage neurovascular bioelectronics medicine 
company developing bloodstream-enabled solutions for previously-untreatable 
nervous system conditions. The company is pioneering the field of 
interventional neuromodulation and developing the world's first motor 
neuroprosthesis, the Stentrode(TM), a brain-computer interface in clinical 
trials to evaluate its ability to help paralyzed patients regain the ability to 
communicate. The company is also developing endovascular neuromodulation 
solutions for the potential treatment of Parkinson's disease, epilepsy, 
depression and hypertension, among other disorders. Development of this 
technology platform was spun out of the University of Melbourne and has been 
funded in part through grants from the U.S. Defense Advanced Research Projects 
Agency (DARPA) and U.S. Department of Defense (DoD). The technology was 
publicly endorsed by then-President Barack Obama as 'technology that has the 
potential to transform lives'. Neuro Technology Investors( 
https://c212.net/c/link/?t=0&l=en&o=2841110-1&h=834127037&u=http%3A%2F%2Fwww.themdadvantage.com%2F&a=Neuro+Technology+Investors 
), LLC, subsequently led the Series A round of financing, which also included 
METIS innovative( 
https://c212.net/c/link/?t=0&l=en&o=2841110-1&h=1782893968&u=https%3A%2F%2Fwww.metisinnovative.com%2F&a=METIS+innovative 
). Headquartered in Silicon Valley, California, Synchron has a presence at 
Newlab in Brooklyn, New York and R&D facilities in Melbourne, Australia.


SOURCE: Synchron Inc.


CONTACT: Tara DiMilia, TellMed Strategies, 908-369-7168, 
Tara.dimilia@tmstrat.com