A University-born start-up has developed a world-first device that helps severely paralysed patients operate digital devices with their minds. Securing AU$52 million venture capital funding, it is set to begin clinical trials in the US.
- The University of Melbourne
- The Royal Melbourne Hospital
- The Florey Institute of Neuroscience and Mental Health
- A minimally invasive device that allows paralysed patients to operate computers with their minds is beginning clinical trials in the US
- Synchron was co-founded by University of Melbourne researchers to commercialise the Stentrode and is the first company to develop a minimally invasive, fully implantable brain-computer device
- The motor neuroprosthesis (MNP) system – known as the Stentrode – is developed by leading medical and engineering experts through a multi-partner project
- Over 30 million people suffer from paralysis, and traditional research has been performed via open brain surgery posing multiple risks.
A tiny, fully implantable device that helps people with paralysis text, email and shop online via thought is about to begin clinical trials in the US. Synchron has raised a total of AU$97 million including AU$52M raised this year from investors led by Silicon Valley capital firm, Khosla Ventures.
Developed by Synchron in collaboration with researchers from the University of Melbourne in partnership with the Royal Melbourne Hospital and the Florey Institute of Neuroscience and Mental Health, the device translates neural information (from a blood vessel near the motor cortex) into on-screen commands, like click and drag.
The US trials, which build on those ongoing in Australia, mark a significant milestone toward making the technology available to physicians.
“These trials pave the way toward a first FDA approval for a brain-computer interface implantable, a critical step to realising the therapeutic potential of this emerging industry,” says University of Melbourne Associate Professor Thomas Oxley, Neurointerventionist and CEO of Synchron.
Established to translate the technology into a commercial product, Synchron is now a leader in the field of implantable brain-computer interfaces (BCI). In the past month Synchron has won the BCI Award for 2021 and the Society of Vascular and Interventional Neurology (SVIN) Innovation Award, as well as been named among TIME’s Best Inventions of 2021 and Fast Company’s Next Big Things in Tech.
Paralysis is an irreversible condition affecting over 30 million people. Traditional brain computer interface procedures involve open-brain surgery, with sensors implanted directly into delicate brain tissue to read neural signals and enable patients to operate external devices.
But open-brain surgeries carry many risks, including infection and bleeding. In addition to causing immediate, localised trauma to the brain, penetrating electrodes also induce an immune response, which has been reported to cause device failure within six months.
A means to bypass complex, invasive surgery and provide a permanent solution to enable patients to regain functional mobility would make it much safer for people with paralysis to carry out everyday activities, and benefit a wider range of people.
The research – coming together to solve the problem
The Stentrode technology is based on research conducted by a multi-disciplinary team of over 40 medical and bioengineering specialists, including many from the University, led by Associate Professor Oxley and Professor Nicholas Opie (co-heads of the Vascular Bionics Laboratory and co-founders of Synchron).
Drawing on the capabilities of each partner, the research team explored all facets involved in developing a safe and permanent BCI that could be inserted via blood vessels, along with the procedure to implant it.
The challenge was to engineer a tiny device that could be embedded with electrodes, collapse to a few millimetres during delivery and self-expand to conform to the curvature and diameter of the implanted vessel once deployed.
“The ability of the device to become incorporated into the vessel and maintain blood flow while also being able to reliably and safely acquire and transmit neural information pertaining to user intent was also crucial.
The University has long-standing relationships with both industry and other institutions. Access to the Florey Institute and the Royal Melbourne Hospital allow access to a wide range of experts.
Technology development history – from bold idea to practical execution
Inspired by various research and an early interest in interventional neurology, the idea for the Stentrode – or using the blood vessels to enter the brain over open surgery – was given wings in 2011 after a meeting with the US Defense Advanced Research Projects Agency (DARPA).
After an initial investment of $1million from DARPA for proof of concept drawing on expertise across the Melbourne Biomedical Precinct, a further development grant of $2.2 million was secured from Australia’s National Health and Medical Research Council.
“Thanks to coordination from Professor O’Brien and an ecosystem of expertise and facilities, we were able to into tap some of the world’s best medical and engineering minds in one place,” Associate Professor Oxley says. “By bringing together neurointerventionists and neurosurgeons, coders, engineers and other disciplines, the concept started to become a reality, and it was very exciting to see it all coming together.”
After three years, the team had the winning design and in 2016 began pre-clinical trials in sheep. With those deemed a ‘success’, in-human trials followed in 2019, initially with two participants.
Early results showed the Stentrode enabled each patient to control texting and typing through direct thought, following a short period of machine learning-assisted training.
A significant leap in brain-computer technology, in 2021 Synchron secured AU$52 million through a Series B investment round led by Khosla Ventures and USD$10M from the National Institutes of Health (NIH) to launch US trials, which will further assess safety and efficacy and finalise protocols for a future FDA-approval trial.
Associate Professor Oxley says Stentrode is remarkably close to becoming the first commercially available implantable brain-computer interface.
“This is a breakthrough moment for the field and we’re excited to have delivered a fully implantable, take home, wireless technology that doesn’t require open brain surgery, which we hope will one day restore freedoms for millions of people with severe disability.”
Additional researchers involved with the project were:
Dr Sam John in the University of Melbourne Faculty of Engineering and Information Technology helped design algorithms to decode neural signals under the guidance of Professors David Grayden and Anthony Burkitt. Professor Clive May at the Florey Institute of Neuroscience and Mental Health helped guide the necessary preclinical studies, and Professor Peter Mitchell and Associate Professor Andrew Morokoff of the Royal Melbourne Hospital gave key advice from a neurointerventional and neurosurgical approach.
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