We’ve all experienced pain. But dealing with chronic pain day in and day out for years on end affects every aspect of your life…your work, your mood, your sleep.
Chronic pain affects a staggering 1 in 4 people worldwide, but there is still no reliable treatment. Opioids, commonly prescribed for pain conditions, give inconsistent and often inadequate relief of symptoms, and can lead to serious side-effects, addiction, and overdose.
Nerve stimulators are available as an alternative to medication. Placed on the spinal cord or peripheral nerves, they use electricity to mask pain signals. While they can be effective, for many people, they fail to provide long-term benefits.
One reason for this is that it is extremely difficult to give enough stimulation using electricity to relieve pain without causing unwanted activation of other nerve fibres.
Bionics Institute researcher Professor Rachael Richardson and her team are investigating a potential treatment that combines the benefits of electrical stimulation with a novel, highly precise stimulus based on light that can be applied directly to the affected nerve. The combination of electrical and optical stimuli is called hybrid stimulation.
Our aim is to develop a hybrid stimulation device that suppresses pain with greater precision than pain medications and allows greater masking of pain than electrical-only nerve stimulators, transforming the lives of people with chronic pain. Prof Rachael Richardson
In their natural state, nerves cannot be stimulated by visible light, but Prof Richardson is a world leader in an emerging technology called optogenetics that uses a genetic modification in specific nerve fibres to make them sensitive to light.
The benefit of stimulating the nerve with light is that only the modified nerve fibres are activated while the other nerve fibres are completely unaffected, making the potential hybrid stimulation treatment much more precise.
In the context of pain, the highly precise neural signals generated by this potential hybrid stimulation therapy are processed in the spine, effectively giving pain signals a red stop light, while all the other neural activity have a green light, ensuring normal movement and sensation.
Prof Richardson’s team have had some excellent results from early research into this method and are now progressing this research to the next stage, which includes a plan to:
- Measure the effectiveness of hybrid stimulation on varying levels of chronic pain
- Develop clinically relevant tools to modify the affected nerves locally so they respond to light
- Engineer a nerve stimulator that can apply light directly to the nerve
- Perform safety studies with the aim of progressing the therapy to clinical trials.
Welcome to the Spring 2025 edition of The Current.
So much has happened since our last update, it’s been difficult to fit it all into one newsletter! Clinical trials with our devices in infants with hearing impairment, people with tinnitus, Alzheimer’s, Crohn’s and Parkinson’s disease continue to progress well, and we have reached major milestones in our early-stage and established research programs. You can find out more in the next few pages, where our lead researchers summarise their recent achievements.
In March, we launched the Vagus Nerve Stimulation Centre of Excellence at our Preview Event, officially opened by the Victorian Minister for Health, The Hon. Mary-Anne Thomas. This exciting initiative will enable our researchers to investigate the viability of a unique method of vagus nerve stimulation as a treatment for a wide range of conditions including gastrointestinal disorders, neurological disorders, mental health conditions, and even cancer.
In April, the Institute was delighted to receive the news that Epiminder’s Minder® device for epilepsy, pioneered by world-renowned neurologist Professor Mark Cook and Bionics Institute engineers, had gained FDA approval. This is an incredible testament to the commitment of a dedicated team of people, and we are all extremely proud that the
technology was originally developed here at the Bionics Institute.
In this edition, I’m very proud to describe a PhD Scholarship set up in partnership with my siblings to support a truly amazing young researcher named in honour of our parents. It really is a wonderful way to support the career of a promising researcher, and I hope that you may be willing to consider similar types of support.
If you would like to find out more about supporting the Bionics Institute, I encourage you get in touch and arrange to come for a tour – it’s fascinating!
As always thank you for your invaluable support, and I look forward to seeing you in our labs or at an event very soon.
Best wishes,
Robert Klupacs
We couldn’t do what we do without your generous support. Here’s a roundup of the progress we have made with your help.
Alzheimer’s disease
“Nearly 30 people have been enrolled into our clinical trial investigating the use of brain stimulation as a potential treatment for Alzheimer’s disease out of a total of 132, and we are continuing to develop the technology with the aim of delivering highly personalised therapy.”
– Professor Kate Hoy
Balance disorders
“My team in the NeuroMovement Laboratory is working closely with Bionics Institute engineers to develop wearable sensors that collect real-time data on movement and coordination, allowing for a more accurate assessment of a patient’s balance condition. It has the potential to detect early signs heightened falls risk, even before they become noticeable to the patient or healthcare provider.”
– Associate Professor David Szmulewicz
Chronic pain
“The Bionics Institute has been researching the use of a combination of light and electricity to improve cochlear implants. We recently started applying this technique to treat chronic pain, and early results are looking promising.”
– Professor Rachael Richardson
Crohn’s disease
“The first patient in the clinical trial of our vagus nerve device to prevent inflammation in Crohn’s disease has completed his 18 months in the trial and continues to feel fit and well. With the support of the Helmsley Charitable Trust we are continuing research into an innovative way to refine the device to provide adaptive stimulation.”
– Professor James Fallon, Chief Technology Officer
Rheumatoid arthritis
“In June this year, we launched our clinical trial to assess safety of vagus nerve stimulation and its potential benefits in reducing swelling and pain caused by rheumatoid arthritis. The Bionics Institute is the sponsor, and the trial is run in collaboration with our clinical team from St Vincent’s Hospital and the Austin Hospital.”
– Associate Professor Sophie Payne
Tinnitus
“We are collaborating with several clinicians to use our tinnitus diagnosis technology to monitor potential tinnitus treatments under investigation, with the aim of finding new ways to relieve symptoms.”
– Associate Professor Mehrnaz Shoushtarian
Infant hearing
“We are engaging with leading clinicians worldwide to refine our EarGenie test of infant hearing so that, once approved for clinical use, it will fast track intervention for infants with hearing loss to optimise their language development. I am excited to be one of the Founders of a newly created company, EarGenie Pty Ltd, which is currently completing its early fundraising activities, to be the vehicle to undertake ongoing engineering and clinical development and to ultimately market products to the audiology community throughout the world.”
– Professor Colette McKay
Hearing loss
“We are currently developing the process to manufacture a clinical grade drug delivery system for potential use in a clinical trial of our innovative therapy that aims to improve quality of life for people with hearing impairment.”
– Associate Professor Andrew Wise
Epilepsy
“We recently published a scientific journal paper on our early research into the potential use of vagus nerve stimulation at abdominal level (aVNS) for neurological conditions. We have shown that aVNS activates the brain region important for alleviating symptoms of a range of neurological conditions, including mental health disorders and epilepsy.”
– Dr Tomoko Hyakumura
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Bionics Institute CEO Robert Klupacs is proud of his family’s history.
He and his siblings Allyson, Andrew and Christopher wanted to find a way to honour the memory of their parents Magdalena (passed away 2010) and Janos (passed away 1979), who arrived in Australia from Holland and Hungary in 1955 and 1950 respectively, to start a new life in Australia.
In 2023, he and his siblings approached the Bionics Institute with the idea of creating the “Magdalena and Janos Klupacs Memorial PhD Scholarship” to support a student who, like them, is the child of first-generation migrants to Australia.
Robert says, “Like so many post war immigrants to Australia, life was very difficult for my parents in the early days in Australia. But they worked hard to give their seven children the best start in life. We all received the best possible education and have gone on to lead rewarding lives. We know that for many children of first-generation immigrants, education is cherished but financial support is often limited”.
We wanted to give a promising student some of the advantages given to us by our parents, Magdalena and Janos. Robert Klupacs
Robert and his siblings, Allyson, Christopher and Andrew have each jointly committed to give a combined $20,000 a year over four years to provide top-up funding for Ella Trang, who is undertaking a PhD at the Bionics Institute in 3D histological imaging.
I am very grateful for the support of the Klupacs Family, not only for the financial support, but also for the moral support for my studies. It’s very special to receive a scholarship in memory of their parents. Ella Trang
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A growing number of business leaders are choosing to give back through their companies—joining forces to drive innovation and breakthroughs in medical research at the Bionics Institute.
The Institute is proud to receive regular monthly donations from a collective of generous companies. Together, these contributions are helping to transform lives through cutting-edge medical discoveries.
One such supporter is Jackson Barrett, Director of boutique law firm Barrett and Co Legal, which specialises in property, healthcare, business, and estate law.
“Barrett and Co Legal are proud supporters of the Bionics Institute,” says Jackson.
“We’re pleased to play a part in advancing its important research.”
Another contributor is Esha Frykberg, Director of Market Street Finance, a firm specialising in commercial loans, home loans, and SMSF loans for business owners and property investors.
It’s powerful knowing that our regular contributions are part of a larger wave of support, Esha
“We’re proud to stand alongside other companies making a real difference.”
Also giving monthly is Dot Advisory, led by Director Warrick Maddocks. Dot Advisory is an accounting and business advisory firm in Melbourne. They specialise in supporting entrepreneurs and small to medium-sized enterprises across all stages of business development.
“I encourage any business owner, director or team member who wants to support medical research to consider joining us in backing the Bionics Institute,” Warrick says.
I encourage any business owner, director or team member who wants to support medical research to consider joining us in backing the Bionics Institute, Warrick
The Bionics Institute is grateful to all its corporate partners for their ongoing generosity and commitment to research that is changing lives.
If you’re interested in finding out how your company can get involved, please contact Sam McLarty at [email protected] to register your interest.
Lean more about how your company can get involved: https://www.bionicsinstitute.org/corporate-giving-information/
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Researchers at the Bionics Institute have published a paper in the journal Neuromodulation: Technology at the Neural Interface demonstrating that vagus nerve stimulation (VNS) at abdominal level activates the brain and shows promise as a therapy for a range of neurological conditions, including mental health disorders, epilepsy and Parkinson’s disease.
Dr Tomoko Hyakumura, who led the research, says that stimulation of the vagus nerve, which runs from the brain to the gut and controls many functions in the body, is a clinically available treatment for drug-resistant epilepsy and depression.
Dr Hyakumura says: “Studies show that activation of a part of the brain called the locus coeruleus is essential for the therapeutic effect of VNS for neurological conditions.
“However, currently VNS is applied at neck level which cause side effects on the heart and lungs, which means that stimulation intensity needs to be reduced with evidence suggesting that this could reduce efficacy of the treatment.”
In response to this, the Bionics Institute has developed a groundbreaking vagus nerve stimulation device that is implanted at abdominal level, and the paper demonstrates that use of our abdominal VNS device in animal studies activates a central brain region called the locus coeruleus, to deliver sufficient therapy without causing side effects to the heart and lungs.
Dr Hyakumura says: “This research shows that abdominal VNS could provide an effective therapy for brain disorders such as drug-resistant epilepsy and depression.
“Our next step is to show efficacy of this device for treatment of these disorders, with the aim of moving towards a clinical trial.”
Dr Hyakumura’s research is conducted within the Bionics Institute’s Vagus Nerve Stimulation Centre of Excellence, led by A/Prof Sophie Payne. Researchers in A/Prof Payne’s team will be investigating the viability of abdominal vagus nerve stimulation as a treatment for a wide range of conditions including gastrointestinal disorders, neurological disorders, mental health conditions, and even cancer.
A/Prof Sophie Payne says the VNS device under investigation for epilepsy, is currently in clinical trial for Crohn’s disease and soon to enter clinical trials for rheumatoid arthritis.
“We have a shortlist of over 20 conditions that could potentially be treated using abdominal vagus nerve stimulation and we will be undertaking research as soon as the necessary funding is secured.”
Read the paper here.
To find out more, about the VNS Centre of Excellence, watch this short video:
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Support Us
Help us find answers to even the most complex conditions, like cerebellar ataxias.
We’re researching new ways that can help improve the lives of people like Dianne.
Dianne’s Story
Dianne used to be a hairdresser. She used to drive. She used to care for her grandchildren.
But as the years have passed, simple everyday tasks have become impossible.
“I don’t like the person I’ve had to become.”
Cerebellar ataxias are a set of cruel degenerative neurological conditions, one of which has slowly stolen Dianne’s independence, her confidence, and the life she once knew.
Associate Professor David Szmulewicz and his team at the Bionics Institute are developing revolutionary wearable sensor technology to measure and track the progression of cerebellar ataxia.
These devices could change everything because there is no clinical way to do this.
Cerebellar ataxia symptoms often resemble those of being drunk, because both affect the cerebellum
Help fund pioneering research
What is cerebellar ataxia?
Cerebellar ataxias are degenerative diseases that affect the same part of the brain as alcohol.
You become increasingly out of control of your speech, balance, vision and ability to swallow.
There’s no way to accurately measure it, slow its progression, or treat it – without research.
Our solution
Associate Professor David Szmulewicz and his team are developing wearable sensors powered by artificial intelligence. These sensors will provide real-time data on movement and coordination, allowing doctors to track cerebellar ataxia progression accurately.
Will you please help to discover new ways to measure and treat currently untreatable conditions like cerebellar ataxia?
What can you do?
– You can break down barriers to diagnosis and care
– You can help develop respectful and equal medical care
– You can enable more tailored and timely interventions to slow progression and improve her quality of life
“If Dianne were to gain access to this technology and know how her cerebellar ataxia is progressing, it could make a huge difference in her daily life.
For starters, it would provide her with objective, measurable data about her condition, helping her and her healthcare providers better understand how her ataxia is evolving, and remove confounding factors that can contribute to misleading impressions of true disease progress and manifestations.”
– Associate Professor David Szmulewicz
Cerebellar ataxia does discriminate
In East Arnhem Land communities, it is estimated that the most common form of this condition can occur up to 180 times more frequently than worldwide.
Cerebellar ataxias disproportionately affect Indigenous Australians living in remote communities.
“My father walked strangely before he died 100 years ago. Now, people are getting sick younger and younger”
– Gayangwa, Angurugu on Groote Eylandt Elder
Want to support the future of research like this?
Research for life-changing devices & treatments like this is made possible by donations from our supporters.
Your support today could help progress new treatments for the future.
Find out how you can support research innovation here.
FDA authorises Epiminder medical device for epilepsy developed in collaboration with the Bionics Institute
We are proud to share that Epiminder’s Minder® device for epilepsy, pioneered by world-renowned neurologist Professor Mark Cook and developed in collaboration with the Bionics Institute, Cochlear Ltd, the University of Melbourne and St Vincent’s Hospital, has reached the major milestone of FDA authorisation.
The US FDA has granted authorisation for Minder® under its De Novo pathway creating a new classification of device, allowing for marketing and sale of the device in the US for patients with drug resistant epilepsy.
Minder® is an implantable device for continuous monitoring of brain activity brain developed to address one of the most persistent challenges in epilepsy care: the lack of accurate, long-term data on seizure activity.
Rohan Hoare CEO of Epiminder, founded in 2017 and headquartered in Melbourne with offices in the US, says that by extending the monitoring window of an EEG from days using current technologies to months or even years with Minder, can deliver unprecedented access to a high-fidelity stream of continuous EEG data to health care professionals and their patients.
He said: “The FDA’s clearance of Minder is a significant milestone for Epiminder and more importantly for the 52 million people around the world who have epilepsy.
“As the first and only implantable continuous EEG monitor approved in US, Minder can provide health care professionals and their patients with more accurate and timely diagnoses, enhanced therapeutic drug monitoring, and can better inform decisions on non-drug treatments like surgery.
“Looking ahead, Epiminder plans to develop a suite of integrated software solutions that will extend the clinical impact of the Minder device, for example by providing patients with advance notice of seizures through AI-enabled forecasting.”
Epiminder intends to formally launch Minder® in the US during H2 2025 undertaking a phased commercial roll out into leading epilepsy centres as part of a program to demonstrate the clinical utility of the system.
You can read more about the device on the Epiminder website: https://epiminder.com/minder-system
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“Long-term investment is key to harnessing Australia’s research and development strengths and further developing our healthcare sector as a global innovation hub.”
Debby Blakey, HESTA CEO
Talking about investment in innovation is critical for the future of Australia’s economy
Over the past three years, the Bionics Institute has been leading the conversation about how we can build Australia through innovation.
Why did we need to talk about this? Because we believe that Australia has so much to gain if we turn to innovation as an essential pillar of our economy.
We started with the launch of our Med Tech Talks podcast, where we interview leaders, investors, researchers and entrepreneurs to explore how we can improve the translation of innovation into commercialisation to change the lives of people living with challenging medical conditions.
The podcast launch was closely followed by our first Innovation Lecture, which has become a highly anticipated annual event convening med tech thought leaders to discuss different aspects of innovation.
Our first White Paper in 2023 drew on the conversations and insights provided by our keynote speakers and podcast guests to elucidate the four ways we can supercharge innovation through: Co-location; skills development and funding; storytelling and persistence; and leveraging mentorship and partnerships.
In this White Paper we are shining a light on investment into innovation: how to source investment; how our investment landscape differs to the United States; how to optimise investment; and finally, how to survive the Valley of Death.
Four critical innovation investment conversation points
Take a look through our White Paper to learn more about:
- Funding Australian innovation to change patients’ lives
- The lure of international markets – particularly the US – and the impact this has on talent retention.
- Keeping innovation onshore so that Australia reaps the benefits
- Navigating the Valley of Death, a challenge every start up must traverse.
1. Funding Australian innovation
In the Foreword to the White Paper, Hesta CEO Debby Blakey explores how investing in Australian healthcare innovation makes good financial sense, creating long-term value for businesses and investors while strengthening the nation’s economy for future generations.
“Australia has the opportunity to create an ecosystem where innovation thrives, and researchers and businesses can access the resources they need to turn discoveries into market-ready, commercial solutions. This will help create a strong pipeline of investment opportunities with the appropriate risk-return profile investors seek to deliver strong long-term investment performance,” Blakey says.
This is backed by ANDHealth’s Bronwyn Le Grice, who says: “The only way to impact millions and millions of patients is through commercialisation.”
She sees the future of Australian innovation building with access to non-dilutive funding from schemes such as the MRFF for medical research.
Co-Founder of Kali Healthcare, A/Prof Fiona Brownfoot says: “The commercialisation landscape in Victoria has changed substantially since we started this as a research project in 2018. In that time, I’ve seen a shift in the Victorian start-up ecosystem – it seems that there is a lot more funding especially in the pre-seed stage.”
2. The Lure of the USA
The White Paper also explores why med tech entrepreneurs are drawn to the United States.
“There’s a cultural fear of failure in Australia that is somewhat destructive for the med tech environment,” says Dr Jeremy Buzzard, co-founder of Induction Bio. “In the United States the motto is: fail fast, fail often and take multiple shots at goal.”
Dr Fouras, founding CEO of 4D Medical bluntly laments the “missing zeroes” in funding in Australia, saying “it’s costing this economy, this country … tens and hundreds of billions of dollars – in my opinion $50 million solutions are not how you solve $100 billion problems”.
To attract much needed capital from US investors he relocated with his wife and five children to Los Angeles in 2016. He still describes his company as driving Australian-led change for lung health. Of his 140 employees in 2023, 18 were in the US.
He says that Australia is challenged by the small size and scope of our VC sector and the disparity of tax incentives. “I could talk about policies that really discourage people from investing in things outside of, for example, real estate in Australia but I don’t want to turn this into a discussion about negative gearing,” Dr Fouras said.
3. Keeping innovation onshore
And the White Paper goes on to highlight what we need to do to keep innovation on shore.
Dr Andreas Fouras, founding CEO and CTO of ASX listed company 4DMedical said that for Australia to achieve its potential to harness innovation and incentivise top companies to stay onshore, the processes around funding need to be innovative, too.
“We can do better and we owe it to the people coming through to make it easier – if we do that, they will reward us 10 times over.”
Stephen and Angela Tomisich, co-founders of Trajan Scientific and Medical, listed on the ASX in 2021, spent four years in the US learning to embrace risk.
Mr Tomisich believes there needs to be a shift in the Australian innovation ecosystem to support developing sovereign capability and keeping it onshore.
“Australia doesn’t have an innovation problem, but we do have a momentum problem,” he says.
“If you take a country like Finland, manufacturing is 15 per cent of their GDP. Australia’s was 15 per cent in 1990, it’s now 5 per cent. Unless we fix that fundamental profile of our economy you don’t get momentum – instead you have start-stop activities.
The stop comes either because the innovation failed or because a multinational liked what they saw and took it offshore. Off that innovation goes and then you have to start all over again.”
4. Navigating the Valley of Death
The tech sector’s infamous Valley of Death is the challenge that virtually every startup must traverse.
Sometimes the dream-ending trek between innovation and profit, is an essential part of the startup ecosystem, says Dr Emma Ball, a biotechnology expert with 25 years’ experience.
She says: “When I’m looking at an investment opportunity, I often refer back to the Six Ts, which I learnt about through investor Professor Pedram Mokrian, who works with Stanford University and the Wade Institute in Melbourne.”
The Six Ts, explained in the White Paper, are:
- Team
- Total addressable market
- Technology
- Traction
- Trends
- Terms.
“There’s a high natural attrition rate in startups and that’s not a bad thing,” says Dr Ball.
“The key is to fail early and fail fast. Learn, iterate and move on. Resources are finite. Every dollar you spend or activity you undertake represents something that isn’t being done instead. So, the quicker you can terminate a project, or an unviable activity means that you can turn your attention and investment dollars to something else more worthy. Embrace the Valley of Death!”
Acknowledgements
The Bionics Institute would like to thank the following people for their contribution to this White Paper:
Dr Emma Ball
Associate Professor Fiona Brownfoot
Dr Chrus Burns
Dr Jeremy Buzzard
Mr Robert Klupacs FTSE
Dr Andreas Fouras
Dig Howitt
Bronwyn Le Grice
Sonya Sawtell-Rickson
Stephen Tomisich
Professor Andrew Wilks
Dr Chris Smith
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Bionics Institute researchers have been awarded a Medical Research Future Fund (MRFF) grant of more than $3.1M over five years to advance research into a debilitating group of disorders known as cerebellar ataxias.
The research is led by neurologist A/Prof David Szmulewicz who says there is an exponential rise in the number of people living in remote communities affected by these diseases, but many remain undiagnosed and untreated due to lack of access to specialist care.
He says: “The most common type of ataxia affects Indigenous people in Australia up to 12,000 times more commonly than the global average. Sadly, most die prematurely from a range of complications including malnourishment, falls, and severe pneumonia related to swallowing difficulties.”
The overall aim of the research is to gain a comprehensive understanding of the diseases and their progression facilitating insights for remote diagnosis, identifying people at risk, disease management and treatment trial readiness.
A/Prof Szmulewicz will work closely with the Bionics Institute Engineering team led by Dr Alex Thompson to develop a suite of diagnostic tools and algorithms to provide insights into the severity and progression of symptoms.
Alex says: “It’s an exciting project to be working on and brings to the fore a skillset of wearable medical device and algorithm development my team at the Bionics Institute is uniquely positioned to deliver.”
For more information about this research go to: https://www.bionicsinstitute.org/our-research/brain-research/measuring-neurological-disorders-of-movement/