OHMR Funded Research Directory

Gene therapy, or the use of genes as medicine, has immense therapeutic potential in the treatment of many genetic diseases and cancers that are currently difficult or impossible to treat. While progress in the development of the underpinning gene transfer technology (vectors) has been hard won, we are finally witnessing astounding successes in human clinical trials in both children and adults.

This in turn has led to a global upsurge in clinical trial activity for a vast number of troubling diseases, and unprecedented demand for gene transfer vectors prepared to the exacting GMP manufacturing standards required for human clinical use. This demand has dramatically out-stripped supply and has created a clinical trial log-jam that threatens to slow the realisation of therapeutic benefit to the many potential beneficiaries of gene therapy.

This project will develop CAR T cells to target a broad range of paediatric tumours, and CAR T cells to protect kidney transplants from chronic allograft nephropathy, as well as gene viral vectors to target blinding eye disease and to treat childhood kidney disease. This will allow us to quickly initiate desperately needed paediatric trials for cancer, eye and kidney disease.

Bone marrow transplants (also known as blood stem cell or stem cell transplants) are the only way to cure the worst types of leukaemia and lymphoma in adults and children.

Patients undergoing bone marrow transplant often die of infection rather than the disease for which the transplant was performed because for a year or more after the transplant, the patient’s new immune system is immature and does not function properly.

Cell therapy involves growing infection and malignancy fighting cells called T-cells in the laboratory, training them to recognize infection and disease, and then giving them to patients soon after the transplant. The idea is to make the patient’s immune system functional and strong soon after transplant and to avoid the period when the patient is most vulnerable to dying.

The proposed clinical trial will test the theory that adding cell therapy to standard antibiotic treatment for infection in patients after bone marrow transplant will improve the immune system leading to better control of serious infections, less serious illness and fewer deaths.

In Australia chronic pain is estimated to cost over $30 billion per year to the overall economy, and current therapies do not adequately address pain for most patients.

The primary aim of this proposal is to generate GMP-grade clinic ready transplant material and then test the safety and efficacy of this material in rodents and large mammals. By moving these new technologies to the pain clinic, we can start to provide some relief to the millions of people currently living with untreatable and devastating chronic pain.

We have developed a long-lasting stem cell therapy that can reverse neuropathic pain, and here we will develop this technology for human use.

The adeno-associated virus (AAV) is gaining widespread use in gene therapy due to its ability to safely and efficiently deliver a genetic payload into a broad range of tissues.

In the clinic, AAV has successfully been used to treat patients with the bleeding disorder haemophilia by delivering a good copy of the Factor IX gene to replace a faulty copy in patient livers. Limitations of previous studies have included a failure to achieve a sustained therapeutic dose and recognition of the AAV particle by the host immune system.

While these problems have been addressed by designing custom AAVs, a tremendous opportunity still remains to further boost therapeutic efficacy by identifying the specific cell entry mechanism or receptor used by AAV’s. We will identify the specific receptors that allow entry of two liver-specific AAVs, one which is already in clinical use, using biochemical and genetic approaches.

We will identify genetic variants that may affect receptor expression and enable us to screen patients for those who will be better responders. We will then screen a ‘library’ of clinically-approved drugs to boost receptor expression and AAV uptake in liver cells in mice. This study will identify new avenues to enhance therapeutic efficacy in patients undergoing gene therapy.

Sudden death or cardiac arrest occurs when the heart goes into a fatal heart rhythm called ventricular tachycardia (VT). These fatal rhythms almost invariable occur due to underlying scar tissue in the heart from a variety of heart diseases. Cardiac arrest survivors receive a specialised form of pacemaker, called an implanted cardiac defibrillator (ICD) placed under the skin that automatically delivers an internal shock if VT recurs, thereby aborting otherwise inevitable sudden death. However, ICDs do not prevent VT from occurring in the first place, they only treat VT when it occurs. Cardiac arrest survivors will experience recurrent VT at an annual rate of 30-50 per cent/year. Recurrent shocks are painful, cause tremendous psychological trauma and lead to increased risk of death. They also lead to frequent hospital visits, and exponential health care utilisation.

Recurrent VT can be treated with strong doses of anti-arrhythmic (AAD) medications but these tend to be minimally effective, and with potent side effects. An alternative is to perform a cardiac ablation (CA) procedure that entails electrical wires navigated up through the veins to the heart, to identify, cauterise and thus destroy the electrical short circuits causing VT. Some studies have shown that CA is highly effective in curing VT, reducing VT burden and improving quality of life in patients with scar tissue due to coronary heart disease (blocked arteries). It is unknown if CA is just as effective for a large population of patients who have scar related to genetic (familial) disease, or infection or inflammation of the heart (termed non-ischemic cardiomyopathy). This group is important as the incidence of non-ischemic cardiomyopathy is rising; such patients tend to be young (30-60 years), and are very likely to experience toxic side effects from AAD and thus stand to gain the most benefit from CA. This research proposal is for a randomised trial that will examine if CA is superior to AAD in the treatment of VT in patients with non-ischemic cardiomyopathy.

Results of this study will be disseminated through clinicians at scientific meetings/publication in journals (and via their social media channels), and by engagement of Sydney Health Partners, NSW Agency for Clinical Innovation and major national/international cardiac societies. Findings will lead to major practice and policy change nationally and globally. Engagement with patients and the general public will be via novel e-health social media channels such as Facebook and Twitter, as well as involvement of charitable foundations.

Atherosclerosis and related complications are a major cause of death and disability in NSW. This project will use see-through zebrafish to literally shed new light on what happens in atherosclerotic plaques using microscopy of the disease inside living zebrafish. We will be able to ask fundamental questions about how plaques form, mature, and harm us by observing the course of disease in zebrafish embryos.

To find new cures of atherosclerosis and it’s complications, the project will take two arms. The first arm will investigate a treatment that may prevent the blood vessel damage necessary for atherosclerosis to get a foothold in our blood vessels while a second arm of the project will set up a zebrafish system to discover new drugs to prevent or reverse the build up of bad fats in atherosclerotic plaques.

Death and disability from stroke is a massive burden on the healthcare system and society. In Australia, it is estimated that one million people will be living with the effects of stroke by 2050 - more than double the number of strokes in 2017. Ischaemic stroke is caused by a blocked artery, leading to a lack of blood flow and oxygen supply to a specific region of the brain supplied by that artery, resulting in brain cell death (infarction). Up to 38 per cent of ischaemic stroke patients present to hospital with mild or rapidly improving symptoms, yet final outcomes are poor, >50 per cent require assistance with self-care at three months post stroke. This delayed progression of stroke due to early neurological deterioration (END) within the first 24hrs post-stroke remains a clinically significant, yet unresolved problem - the number of patients totalling more than the annual number of new cases of multiple sclerosis, Huntington’s disease and motor neuron disease combined. However, its cause and the underlying mechanisms are poorly understood. Currently there are no guidelines or diagnostic tests that can predict the outcome of these patients. Understanding the true pathophysiology and recognising those at risk are key first steps.

Dr Patabendige and her team will use advanced medical imaging analysis and a novel non-invasive method to measure the pressure within the skull, intracranial pressure (ICP) to provide definitive evidence to confirm that ICP elevation causes infarct expansion, and that it is associated with neurological deterioration. In addition, their previous studies confirm that oedema (swelling of the brain) was not the primary cause for this ICP rise. Therefore, Dr Patabendige will investigate whether cerebrospinal fluid (CSF, the fluid that bathes the brain and spinal cord) volume increase is responsible, and if confirmed, show that short-duration hypothermia reverses this.

These findings will provide evidence to confirm the cause for END, and provide for the first time a clear pathological explanation for why these patients, who seem to be improving when initially presenting to the hospital progress to neurological deterioration.

Expected key outcomes:
1. Provide significant fundamental knowledge about a highly clinically relevant, yet unresolved problem of END
2. Help future diagnosis, prevention and management of stroke patients that are at risk of developing END, thereby making a significant reduction in stroke morbidity in the longer term
3. Prove the effectiveness of a potential treatment that is safe, easy to apply and generalizable .

Chest pain is one of the most common presentations to adult emergency departments. Its management requires specialist assessment and tests, which places a significant burden on hospital resources and patients. To address this, Royal North Shore Hospital has implemented a rapid access Chest Pain Clinic (CPC) – a new model of care, for which I am director. As part of this, there is the need for cardiac investigations that are feasible, diagnostic, and cost-effective. Two advanced cardiac diagnostic techniques have untapped potential in this setting in Australia – cardiovascular magnetic resonance (CMR) and advanced electrocardiography (A-ECG). This fellowship seeks to develop new insights into health service of acute chest pain by the application and development of these state-of-the-art investigations to create a paradigm shift in chest pain management and improve healthcare costs.

CMR is the future of non-invasive cardiology, and is utilised widely in clinical practice and research worldwide but less so in Australia because of slow adoption and restrictions with Medicare rebate. In European and UK healthcare models, CMR with stress testing (‘stress CMR’) has been shown to be cost-effective in the management of suspected coronary disease with high diagnostic and prognostic performance. There is a lack of evidence of stress CMR in the Australian healthcare setting. Part 1 of this study will assess the cost-effectiveness of stress CMR in the CPC, in order to optimise its use in Australia.

The traditional ECG is a fundamental cardiac test. Standard analysis depends on visual assessment. Novel methods for computerised ECG measurement permit the application of advanced digital analysis techniques collectively known as A-ECG, which have dramatically higher diagnostic accuracy for detecting disease. Currently, A-ECG is only available in a handful of international centres outside Australia. Part 2 of this study will assess A-ECG in the CPC to show its diagnostic performance, ability to influence downstream tests, and power to predict cardiovascular outcomes. A-ECG could be the much needed paradigm shift in chest pain management – to allow patients to be managed safely as outpatients, thus avoiding hospital admission and unnecessary tests, and improving healthcare costs.

The overarching goals are aligned with Sydney Health Partners’ Cardiovascular Stream and the Northern Sydney Local Health District. Collaboration with international centres of excellence will support the science and the technology. Translation of findings and implementation into clinical practice will be led by the research team, which includes engagement with key stakeholders and hospital administration.

The proposed projects will study new mechanisms that may be involved in a disease that results in increase in blood pressure in the lungs, which is called pulmonary hypertension. This disease is very deadly and despite the progress made, the survival rates within five years of diagnosis remain unacceptably low (up to 50 per cent of patients may die or require heart-lung transplantation). Therefore, research in this area is of high priority.

We will study two different drugs both in the basic science lab, and if these studies support our theories; and as suggested by the safety of the target drugs that are already in use in patients for other diseases; we believe that the second part of the project where we will test these drugs in patients is practically feasible, promising to add two new drugs for treatment of pulmonary hypertension.

I have studied new intricate methods in my post-doctoral studies In the United States which I am excited to establish back in my lab in Australia. This has also provided the team with the opportunity for collaboration with centers of excellence internationally, which will be key in conducting a multi-center clinical study. The proposed team consist of clinician-scientist who can lead both the basic science project and the human trial.

Cardiovascular diseases, including heart attack and stroke, are a leading cause of disease and death. In patients who have experienced a cardiovascular event such as a heart attack, smoking increases the risk of future events and death. Programs supporting cardiac patients to quit smoking improve survival and quality of life, and reduce the burden on the hospital system. However, smoking remains undertreated in cardiac patients. Prescribed medicines, including Zyban, Champix and Nicotine Replacement Therapy, are the most effective strategies available to help smokers quit, but there have been highly publicised concerns regarding their safety among cardiac patients, contributing to reluctance to prescribe and use these treatments.

This project will examine whether these safety concerns are supported by Australian data. It will also determine which of the three medicines is most likely to have the greatest long term benefit for cardiac patients, and the extent to which each of these medicines are currently used by cardiac patients after discharge from NSW hospitals. It will achieve this by linking records of filled prescriptions with other data from health services in NSW. This will be the largest study of the safety and effectiveness of prescribed medicines for smoking cessation conducted to date, and the first conducted in Australia. It will use sophisticated statistical techniques that allow data to be analysed in a way that closely replicates the characteristics of a clinical trial.

This project will provide clinically useful information about the risks and benefits of prescribed quit aids when used by cardiac patients. This will allow cardiac patients and health care providers to make informed decisions about whether a smoking cessation medicine and which one(s), should be used. This evidence, together with statistics on how many patients receive these quit aids after they leave hospital, will indicate whether efforts to promote or discourage use of any of these treatments among cardiac patients are needed. The research team will communicate the findings to staff of NSW Health services, cardiology units in particular, so that protocols and guidelines for the discharge of cardiac patients can be updated. Likewise, the findings will be shared with general practitioners to guide the in-community prescribing of smoking cessation aids to patients with cardiovascular disease. By informing changes to the care of cardiac patients who smoke, this project has the potential to improve the survival of patients with cardiovascular disease and reduce healthcare costs.

Atrial fibrillation (AF), the most common abnormal heart rhythm (arrhythmia), is a major risk factor for both stroke and heart failure. With an ageing population tackling the problem of arrhythmias, in particular AF, will be a major challenge for healthcare in the coming decades. At present, we lack good drugs to treat AF. As a result there is a pressing need for new strategies to study and better understand the molecular basis of these arrhythmias. This is the best way to identify and develop novel therapeutic avenues.

While clinically we accept that altered mechanical load in the chambers of the heart leads to structural and electrical changes, the molecular mechanisms of how these mechanical forces underpin arrhythmias are not understood. This project aims to identify novel mechanical pathways that underlie arrhythmias in conditions like AF.

This project will identify these new cellular pathways underlying arrhythmia generation by evaluating how mechanical stress affects the cells that line the chambers of the heart. We have access to a unique cell type mimicking the single cell layer that lines the inner wall of the heart chambers. Using state-of-the-art technology to simulate blood flow this project will assess how these cells may provide mechanically-regulated signals to the underlying heart muscle cells and assess how this may contribute to arrhythmias. This crucially acknowledges the inseparable function of the specialized cells that line the heart chambers and the muscle cells in the overall performance of the heart. Understanding these molecular pathways and their effect on the underlying heart muscle will likely identify novel therapeutic targets for prevention but also for management of arrhythmias.

Aside from unearthing targets for therapy, these pathways are also likely to contain candidate genes for genetic studies in patients with inherited heart arrhythmias and atrial fibrillation. Thus data generated in this study will be used to look for disease causing gene variants in studies already ongoing such as a NSW Health funded project aimed at sequencing the genomes of a large cohort of patients with cardiomyopathies, many of whom will develop AF and associated arrhythmias. As a result this project is likely to provide tangible outcomes for patient and family management and counselling.

Cancer and heart disease are the two most common disease conditions and the leading causes of death. Chemotherapy is more effective than ever at treating cancer, but has a price. There are over 400,000 cancer survivors in Australia and this figure is expected to increase due to a continuous decline in cancer death rates: there is a 70 per cent chance of survival from cancer in Australia. However, up to 25 per cent of these cancer survivors die from chemotherapy-induced cardiotoxicity (CIC) within 7 years, making it the leading cause of death in cancer survivors.

Cardio-oncology, an under-recognised area in Australia, is the intersection of heart conditions in cancer patients, an emerging field with immense potential to improve quality of life and cardiovascular burden in a growing number of cancer survivors.

The main reason for long-term cardiovascular and healthcare burden is delay in early detection of CIC due to imperfect diagnostic techniques. This is a major limitation, as early detection and treatment of CIC can lead to prevention of heart failure, and recovery of heart function. In addition, lack of an integrated, patient centred approach in Australia results in the fact that most cancer patients are still largely unaware of this adverse drug reaction and tend to neglect care for risk factors that may precipitate cardiotoxicity.

Thus, our program aims to address poor outcomes for the many cancer survivors who go on to develop CIC by discovering simple blood test(s) that could detect early onset of CIC as well as providing better education and facilitating self-care and empowerment for cancer patients/survivors.

Specifically, I will utilise state-of-the-art high through-put techniques that can gather a large amount of data to identify:
1) proteins in blood that change with early onset of CIC
2) genetic markers
3) chemotherapy-induced changes in genetic dispositions (epigenetics).

This data will be combined with latest imaging modalities to develop an individualised risk prediction tool for our patients. As risk assessment and early detection are cornerstones of early treatment and improved outcomes, this could in future lead to change in clinical practice/guidelines and translate in earlier discontinuation/change in chemotherapeutic regimen and initiation of cardioprotective therapy. I will also establish and facilitate a dedicated cardio-oncology nurse-led program of patient education and empowerment. This would achieve both improved interdisciplinary communication related to the diagnosis, monitoring and therapy of cancer treatment related cardiovascular complications and improved patients’ journey and outcomes through improved and dedicated cardiovascular care.

Blood clots blocking the blood supply to the heart and the brain, known as arterial thrombosis, cause heart attack and stroke – the leading cause of death and disability in the Australia. Platelets are the cells that form these blood clot, thus drugs targeting platelets such as aspirin are the mainstay of heart attack and stroke prevention. Yet current treatment has limited effectiveness with optimal therapy – up to 30 per cent of patients will have a recurrent event within three years, and more effective therapies often lead to bleeding side effects.

Our work has identified a particular sub-set of platelets within people with cardiovascular disease that increase blood clots, but are not turned-off by aspirin. These are called procoagulant platelets. Measurement of procoagulant platelets in patients has initially been very difficult due to the lack of sensitive and specific tests. We have recently developed a way to measure procoagulant platelets in people at risk of heart attack and stroke, and have shown that more procoagulant platelets are indeed formed during stroke and heart attacks. It is therefore this sub-set of platelets in people with cardiovascular disease that we would like to target more specifically when designing new drugs, in order to increase the beneficial effect and at the same time reduce the bleeding side effect when treating patients.

Interestingly, a simple non-invasive process called remote ischaemic preconditioning (RIPC), which is performed by inflating and deflating a blood pressure cuff three times, was able to reduce procoagulant platelets in people with heart disease when aspirin and other anti-platelet drugs could not. Others have previously shown that RIPC can protect the heart muscle and brain from damage during heart attack and stroke, but the mechanism by which it does this is unknown.

My studies indicate that RIPC affects procoagulant platelets by affecting the platelet mitochondria. Mitochondria are organelles inside the platelet that converts glucose to energy. My project investigates the link between procoagulant platelets, platelet mitochondrial function and cardiovascular disease. In addition to providing the rationale for RIPC, these studies aim to identify platelet mitochondrial pathways as a novel target for cardiovascular disease that will work in addition to existing cardiovascular drugs without causing bleeding. Ultimately, our work would be able to provide more tailored therapies for patients, reduce our patients’ waiting time, pain and risk of receiving treatments, improve their disease outcome, and reduce medical cost for the NSW health system.

Heart failure rates are increasing exponentially in Australia and worldwide. One in two people diagnosed with severe heart failure will die within one year of diagnosis. This burden of heart failure is underpinned by the heart’s limited capacity for self-repair after injury. This limitation could be overcome by stimulating newly discovered stem cell populations residing within the adult heart itself. We recently discovered a cardiac colony-forming stem cell population and have found that the molecule Platelet Derived Growth Factor (PDGF) can improve the heart function of mice and pigs after induced heart attack. PDGF does this by activating and rejuvenating resident heart stem and stromal cells. Before this promising therapy can be considered for clinical trials in humans, further testing to validate its safety is required.

This project will build on over a decade of preliminary work in mice and pigs, validating our results in a preclinical large animal model. In the second phase of this work, new materials such as nanoparticles will be used to more selectively deliver PDGF therapy to the heart. Outcomes of this project include expedited progression of this promising therapy, from the laboratory into the clinic, where thousands of heart failure patients could one day benefit.

Note: This project received project funding only. This project did not received full Fellowship funding.

Heart defects are the most common form of birth defects, occurring in ~1 per cent of live born babies. In 80 per cent of families it is not known why they occur. We use the latest technologies to study the genetic code of families with children that are born with heart defects. We aim to identify mutations, i.e. changes in the genetic code that are the cause of these defects.

The genetic code of each individual is stored in large datasets. Our goal is limited by the current methodologies to analyse such large datasets to identify causal mutations. Currently, a large percentage (~70 per cent) of families we study cannot receive a personalised genetic diagnosis. We propose to develop new quantitative and analytical approaches to improve our ability to identify mutations that are the cause of heart defects in every family.

Our research has specific and immediate clinical benefit for the families affected with heart defects that have been recruited. Increasing the genetic diagnosis of heart defects will help more families receive an accurate genetic diagnosis, personalised advice concerning the disease in their family and a better estimate of the risk of having a subsequent child with a heart defect.

Identifying the genetic causes of heart defects not only has benefits for the patient and the family but also for the community. Currently, efforts to identify causes of disease require large costs, and it can include multiple medical screens and procedures. We expect that systematic adoption of genetic testing in clinical practise will improve the financial sustainability of the health system.

Note: This project received project funding only. This project did not received full Fellowship funding.

Hypertrophic cardiomyopathy (HCM) is a clinically variable disease, ranging from asymptomatic diagnoses, to heart failure and sudden cardiac death. It occurs in 1 in 200-500 of the general population, and given it is an inherited disease close family members are recommended to undergo lifetime clinical surveillance. Due to the wide variability in disease presentation and features, there is little ability to predict who will develop the worst outcomes, despite decades of research.

Recent advances in genetic technologies have allowed an opportunity to better understand the underlying genetic causes of HCM, but have also challenged the prevailing view that HCM is primarily an inherited disease. My recent paper in Circulation: Cardiovascular Genetics proposed for the first time that a non-familial sub-group of HCM exists and that it occurs in approximately 40 per cent of cases. Non-familial HCM patients have a less severe disease and while current clinical guidelines recommend lifetime clinical screening of their first-degree relatives, our finding suggests this is not necessary.

No study to date has focused exclusively on the familial HCM sub-group. Reassessment of risk algorithms in a more homogeneous patient population will allow development of accurate risk prediction scores. Until now, risk scores have been developed in populations including both nonfamilial and sarcomere positive HCM and not surprisingly show poor predictive ability. To date, no scores have incorporated genetic variables, and based on my recent work there is a strong likelihood that genotype can impact outcomes.

For the first time, genetic testing could offer a clearer way to understand the disease, allowing us to make more precise recommendations for family screening and better predict those more likely to have poor outcomes. This will reduce uncertainty, but also minimise unnecessary health care resources from clinical screening family members who are not at increased risk of disease.

Note: This project received project funding only. This project did not received full Fellowship funding.

The purpose of this research project is to develop and validate a blood test that can be widely used, e.g. hospital outpatients, and general practitioner offices, to detect a new molecule in blood that we discovered. It will indicate whether a patient has liver fat and whether they are at risk of developing diabetes, which frequently leads to heart disease and stroke.

We are facing a global epidemic of obesity and related diseases. Almost three-quarters of Australians are now overweight or obese, and childhood obesity is at an all-time high. Overweight and obese people have a high risk of developing fatty liver disease and/or type 2 diabetes. Fatty liver disease is often the first stage leading to type 2 diabetes, and puts patients at increased risk of fat deposits in their blood vessels that may cause heart attacks and strokes, which are the most common causes of death in these patients.

We are failing to prevent the catastrophic obesity epidemic. It is a global challenge. The numbers are far greater in developing countries. In China, for example, 114 million people have type 2 diabetes and half a BILLION have prediabetes. These staggering numbers underscore the enormity of this healthcare challenge globally.Although obese people with diabetes most commonly die from heart attacks and strokes, the rate at which this occurs is highly variable, and until now, we cannot predict who is most at risk and who will have an event.

Our results indicate that the new blood molecule discovered by us can predict, more than a decade in advance, who will develop diabetes. This is tremendously important, as it will allow us to target those most at risk with interventions to prevent them from developing diabetes, thereby reducing complications such as heart attacks and strokes. It has been repeatedly shown that the best way to prevent diabetes and its complications is early intervention – by the time of diagnosis a lot of damage has been done, most of it irrevocably.

The way we currently measure this molecule is not widely accessible, limiting its availability to populations that need it most. In this project, we aim to develop a test that can be used everywhere -- even at the bedside, outpatients, general practitioner offices -- and will be fast, precise, and reliable. We will ensure that the public, patients, and clinicians are fully aware of all aspects of this assay.

Note: This project received project funding only. This project did not received full Fellowship funding.

Increasing life expectancy has resulted in a higher proportion of older individuals (≥65 years) in the population compared to a decade ago. As the population ages, demand will increase for hospital and aged care services, including permanent residential aged care (RAC), respite RAC, and transitional care (TC). The number of injury-related hospitalisations for older individuals are growing, accounting for 27 per cent of hospitalised injury.

Following an injury, older individuals may require assistance to perform activities of daily living (ADL), either transitionally as they return to their prior ability, or on a more permanent basis. Prior research has identified that age, functional ability, cognitive impairment, depression, multimorbidity and falls are commonly associated with aged care placements. However, individual and psychosocial characteristics associated with admission/return to RAC have not been examined following a hospitalised injury at a population-level, nor have factors associated with entry into supplementary care programs, such as TC or respite RAC, been identified. For older individuals, there is limited information available regarding their care transitions between the home, hospital, RAC, respite RAC and TC following a hospitalised injury in NSW. Suboptimal care transitions may result in diminished ADL and increased costs, including through re-hospitalisation.

This research will examine factors that influence older individuals transitioning between services and will advance the understanding of the influence of individual and psychosocial characteristics on post-acute care placement of individuals who are hospitalised following an injury. Ultimately, this information will be invaluable in influencing policy, driving change, and informing planning of the post-acute phase healthcare for older individuals in NSW and to identify future priority areas for research.

The promise of e-health interventions as a solution to overcome current healthcare challenges such as accessibility and cost have been hampered by poor translation into the community. Despite major advances in the availability of evidence-based mental health programs there is a serious shortfall in the delivery of such programs in practice, with an estimated 17-year delay between the identification of an effective program and its integration into practice and policy domains (IOM, 2001; Westfall, 2007). A significant contributor to this problem is the lack of available skills and knowledge to conduct rigorous interdisciplinary implementation science research.

The goal of this project is to inform the implementation of an evidence-based e-health intervention to prevent the onset of depression in youth. The intervention, SPARX, is a six-session online ‘serious game’, based on the principles of Cognitive Behaviour Therapy, which we have adapted into a prevention program (SPARX-R) for adolescents. In an randomised-controlled trial conducted across 10 Sydney high schools we showed that SPARX-R prevents the onset of depression, with gains maintained at 6-month follow up (Perry et al., 2005; the trial is ongoing and 18-month outcomes are expected in August 2016). SPARX-R does not require extensive training to support its delivery, making ideal for the school context.

A better approach to bridging the gap between ‘what we know’ and ‘what we do’ in health could make a substantial contribution to improving health outcomes and efficiencies. Increasingly it has been recognised that research to bridge this gap (implementation research) requires the expertise of researchers, policy makers and practitioners to be combined; implementation projects require both a deep understanding of the real world and how it operates, along with the often sophisticated research skills necessary for complex research designs. This is commonly referred to as partnership or co-production research.

Co-production, where researchers and research users work together throughout the research process from question formation through to interpretation and dissemination of findings, appears likely to be the most effective model for partnership. Such partnerships are a relatively recent phenomenon, however, and there is much to be learnt about how best to bring the diffuse skills, needs and priorities of these groups together to drive more effective implementation research and reduce research wastage. In Australia, the promise of co-produced research has led to the creation of funding schemes designed to foster collaboration (e.g. NHMRC partnership grant, NSW Health Translational Grant Scheme) but it is unknown how effective these partnerships are or how they operate in practice.

The specific aims are to:
1. Understand how research/end user partnerships are currently enacted in New South Wales, what works and what does not: and
2. Evaluate, for the first time internationally, a suite of tools to strengthen coproduction in implementation research:
a. A training course for early career researchers to build their capacity to develop and sustain effective research partnerships with policy agencies;
b. A tool for research users to help them navigate the process of working with researchers, from the initial agreement to partner through to dissemination.

This project is a joint collaboration between the Northern Sydney Primary Health Network (PHN), Healthdirect Australia, Hornsby General Practice (GP) Unit (a NSW Health entity), Macquarie University Health Services, and the Australian Institute of Health Innovation. It is designed specifically to realise the vision of “a digitally enabled and integrated health system delivering patient-centred health experiences and quality health outcomes”, set by NSW Health in its recently released eHealth Strategy (2016-2026).

General Practitioners (GPs) tend to refer patients to the Emergency Department (ED) in order to ensure their patients receive affordable specialist care without extensive delays. They may not be aware of outpatient services available at their local hospital. This contributes to unnecessary ED access block and increased waiting times. Patients are frustrated by months of waiting for outpatient appointments, and they lack skills in self-management in the interim.

To address this, health pathways (a collaborative initiative between primary and secondary health providers to improve the referral and management of patients) have aimed to build capacity in general practice to help patients navigate the health system. Supported by the NSW Agency of Clinical Innovation (ACI), health pathways are implemented and evaluated across NSW.

This research will make use of the unique opportunity at the NHMRC Centre of Research Excellence in eHealth which is co-located within the Northern Sydney PHN. The PHN will develop its first 20 local health pathways over the next six months. We will work closely with the PHN to select two high-priority health pathways and conduct studies to 1) understand the pain points experienced by consumers in their journey through the current service landscape (e.g. inability to get timely access to specialist care; lack of self-management skills due to limited health literacy); 2) co-design a consumer portal to address these challenges with input from consumers, GPs, clinicians and health service practitioners; and 3) evaluate the acceptance of the portal from consumer, GP and health service practitioner perspectives.

Burn injury can be a traumatic event for both the child and their carer, requiring extensive, specialised care and protracted hospitalisations. For paediatric burn injuries, optimal outcomes are associated with good multidisciplinary care, consistent follow-up with high quality burns units, functioning family units, and early return to pre-burns activities. In Australia, Aboriginal and Torres Strait Islander children are over-represented in burn-related hospitalisations yet, no research until now has examined the outcomes of these children nor their access to care either immediately after the burn injury or following discharge from hospital.

In addition to being more likely to be hospitalised following a burn injury, unpublished data suggest Aboriginal and Torres Strait Islander children are less likely to be treated in a specialist tertiary burn service.(Moller, unpublished). The NSW ACI Statewide Burn Injury Service, NSW Burn Transfer Guidelines provides clear guidelines for paediatric burn referral to tertiary burn services. However, there is evidence to suggest these guidelines are inconsistently applied. The proportion of Aboriginal and Torres Strait Islander children treated at specialist tertiary burn services in NSW is lower than population expectations. Further, numbers treated in regional centres appear to be higher, suggesting children are not referred as per the guidelines.

PIDs result from monogenic mutations in genes crucial to the functioning of an intact immune system. Currently, mutations in ~290 genes have been identified that cause PID. However, there are many more cases where the genetic lesion is unknown. This project will perform WGS on these PIDs to reveal the underlying gene mutation.

This “from bedside to bench and back” approach incorporating genomics and bioinformatics will identify novel gene mutations in PID patients and provide an explanation for disease pathogenesis. While PIDs are rare, they have played an instrumental role in pinpointing the essential and non-redundant roles of genes in the development and function of immune cells. Furthermore, some of the complications affecting PID patients are prevalent in the healthy population; for example, the incidence of thrush due to chronic fungal infections. In addition to having direct affects on clinical policy/practice ie treatment regimens for affected patients, results will be disseminated via the publication of manuscripts, presentations at national/international conferences and via media outlets through the work of the Garvan Research Foundation.

The top causes of disease burden among Australians (15–44yrs) are dominated by mental health and substance use disorders. Of particular concern is the common co-occurrence (i.e. comorbidity) of disorders, with up to 50 per cent of people presenting to services with more than one disorder. Despite increased awareness and public concern leading to a major government initiative (National Comorbidity Initiative), comorbid mental health and substance use remains a major cause of disability, poor quality of life, early mortality and poses a significant challenge for the Australian health system.

Evidence suggests that integration of substance use and mental health treatment is ideal for optimal patient outcomes and to avoid patients falling through the gaps. Individuals with comorbidity however, continue to receive disparate care targeting either the mental health or substance use disorder. NSW Health is well placed to be the leader in responding to this crisis by translating high quality comorbidity research evidence to practice. The improved clinical management of comorbidity is a priority for NSW Health and is consistent with the NSW State Health Plan: Towards 2021 which aims to deliver truly integrated care by providing right care in the right place at the right time.

The purpose of this project is to directly address this priority by implementing effective models of translation to increase the capacity for NSW treatment services to respond to comorbidity. The specific objectives are to:
1. Employ standardised US toolkits for assessing comorbidity competency (DDCAT and DDCMHT) and adapt them for adolescent and adult treatment services in NSW and Australia
2. Implement these adapted toolkits and evidence-based recommendations in NSW treatment services to examine utility in assessing comorbidity competency and enhancing capacity to respond to comorbidity.

A transient Ischemic Attack (TIA) is a major warning sign for stroke. There is a 15 per cent risk of stroke ≤ 90 days following initial event and the risk of cardiovascular events remains high 10-15 years post-TIA. It is best practice for TIA patients to receive secondary medical care to determine TIA cause and to commence preventative pharmacological therapy early post-event.

Behaviour change programs which include education and group exercise (ie. advice and support to address modifiable cardiovascular disease risk factors including hypertension, inactivity, poor diet etc) significantly reduce the odds of further cardiovascular events. These programs significantly increase the time TIA patients spend in moderately vigorous physical activity (ie. brisk walking) (5). The latter extremely important as increasing physical activity independently contributes to significant reductions in cardiovascular risk, with an inverse relationship between time spent in moderately vigorous physical activity and risk of cardiovascular events and all-cause mortality.

This project aims to :
1. Develop and implement a new service- a behaviour change program for people who have had a recent TIA (Study 1: Implementation Study)
2. Increase the minutes/week people who have had a recent TIA spend in moderately vigorous physical activity (Study 2: Outcomes Study).

Antibodies are the effector molecules of the immune system and are responsible for neutralising pathogens with remarkable specificity and memory. However, 5 per cent of Australians suffer from autoimmune diseases, such that their antibodies recognise their own cells, tissues and organs (autoantibodies). Autoantibody-mediated disorders account for a large burden of chronic disease and can be difficult to diagnose and treat due to heterogeneous symptoms ranging from arthritis, dry eyes/mouth to kidney failure and giving birth to a child with cardiac abnormalities. The unpredictability of disease outcomes reduces patient quality-of-life, while posing significant costs to healthcare systems for ongoing monitoring and treating symptoms as they occur. Treatment options are limited to non-specific steroids and expensive biologics that are only effective in a subset of patients.

The objective of this research is to use cutting-edge genomic technology to characterise human autoantibodies to improve diagnosis and monitoring of disease. This approach traces the cellular source of autoantibodies revealing novel and specific therapeutic targets.

There are two ways to characterise an antibody: i) antigen specificity - what the antibody interacts with; ii) the genes that form the antigen binding site on the antibody (variable (V), diversity (D) and joining (J) genes). For the last 40 years, the former method has been employed by clinical diagnostics to detect autoantibodies but has limited value for predicting disease outcome. For example, maternal autoantibodies binding the Ro self-antigens are associated with foetal cardiac abnormalities such that weekly echocardiograms from 12-22 weeks gestation are recommended for all Ro autoantibody-positive pregnancies. However only 2 per cent of these pregnancies result in this disease. A more specific biomarker would identify patients at highest risk, allowing for early intervention and improved disease management.

Advances in genomic technologies for sequencing antibody genes now make it possible to evaluate VDJ-genes for diagnostic purposes. Specific VDJ-genes have become useful diagnostic and prognostic indicators of lymphoma. Extending this approach to autoimmunity creates the exciting possibility of stratifying autoantibodies according to VDJ-gene usage and clinical symptoms. Previous research by others and myself has revealed distinct subsets of Ro autoantibodies that cause disease pathology. These “pathogenic” Ro autoantibodies cannot be distinguished from “quiescent” Ro autoantibodies by routine diagnostic assays. Genetic analysis of Ro autoantibodies is limited but has revealed biases in VDJ-gene usage across multiple patients. This research will extend these promising preliminary studies to evaluate the diagnostic utility of sequencing VDJ-genes and reveal where autoantibodies come from.

Mental and substance use disorders account for more years of life lost due to disability than any other disorders and are second only to cardiovascular disease and cancer as leading causes of disease burden. Comorbidity of mental and substance use disorders pose a significant challenge for the Australian health system. The silo structure of the healthcare system has historically treated clients in parallel by different treatment providers. Typically, treatment is incomplete and outcomes are poor.

The NHMRC Centre of Research Excellence in Mental Health and Substance Use (CREMS) leads the way in new research examining innovative treatments for comorbidity. NSW health services provide a unique context into which new approaches to comorbidity treatment can be embedded. Our research has demonstrated that an integrated, stepped care (ISC) approach is ideal for optimal client outcomes and to avoid clients falling through the gaps.

Integrated care involves both substance use and the mental health condition being addressed by the same provider. This can be facilitated by a stepped approach where additional care is provided for a mental health diagnosis after stabilisation from substance use, enabling the distinction between substance-related mental health symptoms versus symptoms remaining or emerging once use has resolved.

This project aims to:
i) Evaluate the impact of a Multi-modal Translation Intervention Package (MTP) to (a) increase ISC proficiency and uptake; (b) enhance clinician knowledge and attitudes; (c) improve substance use and mental health outcomes.
ii) Examine barriers and facilitators of ISC implementation using the MTP.
iii) Deliver MTP resources and sustainability recommendations to NSW Health for future rollout.
Promote identification, assessment and clinical management of comorbidity within the drug and alcohol services of NSW local health districts.

Genomic technologies, including targeted sequencing, and more recently, whole genome sequencing (WGS) have generated unprecedented insights into the molecular basis of disease. The application of WGS to patients with rare Monogenic Disorders is now identifying a molecular diagnosis in approximately 50 per cent of patients. The ability for WGS to characterise structural variants (SV) has redefined the genomic landscape of many cancers, providing treatment insights that were not possible from targeted sequencing approaches alone. One of the greatest challenges for precision medicine is the translation of bioinformatic methods developed in the research setting, often to study cohorts, into the clinic. Methods must be accurate, fast, comprehensive, interpretable by a multidisciplinary team, and must apply to the n-of-1 patient-centred situation.

The purpose of this proposal is to improve the clinical management of patients with inherited genetic disease, through increasing the diagnostic yield in rare disease, or improved tumour characterisation. The objectives of the proposal are to continue to develop a suite of bioinformatic approaches to uncover different aspects of genome biology and assess how these influence disease, and ultimately to translate these methodologies into clinically accredited tests. Many of these aspects of genome biology can only be uncovered by WGS. As we have already developed Australia’s first clinically accredited^ WGS-based diagnostic test for investigating single nucleotide variants (SNVs) and small insertions and deletions, we are uniquely positioned to achieve these objectives.

This proposal will develop critical bioinformatic and translational capability to improve patient care in NSW, and beyond.

This screening and secondary prevention project could help reduce the burden of stroke worldwide by introducing a novel, scalable, cost-effective technology to screen for post-operative atrial fibrillation (POAF) following cardiac surgery discharge. This project could influence policy and AF management guidelines to include routine monitoring for POAF recurrence.

POAF occurs in 25-40 per cent of cardiac surgery patients, and is associated with increased mortality and stroke risk. POAF is thought to be transient and self-correcting, thus patients discharged in stable sinus rhythm are rarely followed up. POAF recurrence is often missed as it is largely asymptomatic or has non-specific symptoms. Additionally, patient knowledge of the extent of AF symptoms is poor despite inpatient education. In my systematic review (n=6 studies) active monitoring post-discharge identified POAF recurrence in 33 per cent of patients with transient in-hospital POAF, and late-onset POAF in ~4 per cent with no prior POAF. I have shown self-monitoring for POAF recurrence is feasible using a smartphone handheld ECG (iECG).

The outcomes from this study will assist development of a risk score to better identify patients at highest risk of devastating complications, such as stroke, allowing clinicians to better target effective preventative therapy. The project aims to:
1. Determine the incidence and predictors, and explore the prognostic significance of recurrent POAF and late-onset POAF
2. Determine if education using a 'graphic app' improves patient knowledge, particularly awareness of POAF symptoms
3. Determine scalability of self-monitoring using an iECG.

Cardiovascular disease is the leading cause of premature death among Aboriginal Australians and there is increasing disparity in rates of cardiovascular-related deaths between Aboriginal and non-Aboriginal Australians. From 2008-2012, non-communicable diseases, such as cardiovascular disease and diabetes, accounted for 81 per cent of the gap in mortality rates. Obesity (16 per cent) and physical inactivity (12 per cent) are leading risk factors in the development of chronic disease and the overall health gap in Aboriginal Australians.

Obesity is responsible for 1-3yrs of the 10-yr gap in life expectancy. Higher levels of these modifiable risk factors that contribute to this health disparity among Aboriginal adults are already present in Aboriginal children. Compared with their non-Aboriginal peers, Aboriginal children are 1.4 times more likely to be overweight or obese, 1.8 times more likely to exceed screen time guidelines and 1.6 times more likely to have unhealthy eating habits. The risk of type 2 diabetes in Aboriginal children is 8 times higher than in their non-Aboriginal counterparts.

As cardiovascular disease is one of the leading contributors to the life expectancy gap, there is a need to better understand the key modifiable behaviours of cardiovascular disease, such as physical activity (PA) and sedentary behaviour (SB), and better understand culturally acceptable ways to promote healthy levels of these behaviours among Aboriginal children. This evidence is currently lacking for Aboriginal children and is critical to improving cardiovascular health behaviours in Aboriginal Australians.

Conducting research with Aboriginal communities is a long-term commitment, requiring respectful negotiations within the research partnership, which can only occur through continuous and consistent relationship building. This fellowship will build on a 2-year partnership with three Aboriginal communities in NSW. A priority identified by these communities is to raise healthy children and provide their children with opportunities to connect with Country and culture. This fellowship will use a behavioural epidemiology framework to understand PA and SB behaviours among Aboriginal children and how these health behaviours relate to cultural connectedness.

Specifically, this project aims to:
1. Determine the prevalence and patterns of PA and SB and their associations with cardiovascular health.
2. Identify the cultural determinants of PA and SB;
3. Design, implement and evaluate an afterschool Aboriginal cultural program to promote healthy lifestyle behaviours; and
4. Translate the evidence into dissemination strategies of Australia’s Physical Activity Guidelines to 5-12 year-old Aboriginal children.

This project will address an internationally-important healthcare problem in hospital emergency departments: with a surging demand for services, how can we ensure a safe environment for patients while still maintaining throughput?

In the first quarter of 2016 there were 672,483 presentations to NSW emergency departments (EDs) – a 9 per cent increase in triage Category 1 patients, and a 4 per cent increase in presentations overall compared with 2015. Despite introduction of National Emergency Access Targets across Australia in 2010, 25 per cent of patients were not ‘seen on time’ in accordance with Australasian Triage Scale standards, and 26 per cent of visits were not concluded within 4 hours. Increasing numbers of patient presentations, coupled with limited in-patient bed capacity, can result in long waiting times and prolonged lengths of stay in the ED. Overcrowding is becoming more prevalent, and has been associated with an increase in medical errors and poor patient outcomes, including death.

When EDs get overloaded, things are more likely to go wrong (e.g diagnostic errors, medication errors, delayed treatment). The processes we put in place to prevent errors from occurring often add to workload in the ED, paradoxically making it even more likely that things will go wrong. A new way to solve this dilemma is to shift our focus from preventing things going wrong, to increasing the number of things that go right. We call this ‘productive safety’. The purpose of this project is to design and implement ED processes to improve productive safety in NSW public hospitals. This project will seek to identify key quantitative and qualitative measures that are predictive of productive safety in response to unexpected events and periods of peak patient demand in the ED. Based on these measures, processes will be developed for assessing and improving productive safety. By doing so, we will assist ED leaders and clinicians to evaluate their organisation, and implement action to improve the number of things that go right when faced with challenging or unanticipated conditions. Such a proactive effort is likely to strengthen ED responses to threats and crises, and thereby save money and lives.

The project aims are to:
1. establish baseline measurement of productive safety in EDs in NSW public hospitals
2. refine productive safety processes, following an in-depth study of two NSW ED cases
3. develop a suite of context-dependent and generic tools to support re-design of processes to improve productive safety in EDs in NSW public hospitals.

Mitochondrial diseases are the commonest group of inherited metabolic disorders. Children often present with severe disease that is fatal in two thirds of patients before the age of 16. Adults tend to endure chronic and progressive disease that is often be severely debilitating and precludes them from employment. Mitochondrial diseases are notoriously difficult to diagnose due to the diversity of genetic causes (>300 mutations in mitochondrial DNA and >150 known nuclear disease genes), the extreme variability in clinical presentation (the same mutation in a family can manifest very differently) and a lack of comprehensive and definitive diagnostic tools.

The current diagnostic pathway involves invasive, expensive and inaccurate testing that often results in patients going undiagnosed or being misdiagnosed and spending years trying to access appropriate healthcare. This project will evaluate two new diagnostic tools, metabolomic biomarker profiling and genomic sequencing, in order to define a rapid, cost-effective, comprehensive and accurate diagnostic pathway that will improve the diagnosis of mitochondrial diseases.

Accurate diagnosis enables specialist clinicians to encourage disease modifying lifestyle changes, to administer appropriate treatments, identify and avoid contraindicated pharmacological agents (e.g. the common antiepileptic sodium valproate can cause death in mitochondrial disease patients presenting with seizures) and to provide informed family planning. The accurate diagnosis of mitochondrial diseases would also have a significant impact on the cost to NSW Health associated with undiagnosed or misdiagnosed patients, would enable treatment development through better understanding of disease pathophysiology in defined disease-specific cohorts, would define patient cohorts for genotype-specific clinical trials and enable appropriate treatment administration to those who will benefit most.

As genomic sequencing and bioinformatic analysis costs are still considerable, the first objective of this project is to develop metabolite signatures (combinations of small molecules that can be used to define a disease discriminatory test) of the mitochondrial disease group and individual mitochondrial diseases. This frontline indication of disease will inform clinical decision-making on whether to progress to other diagnostic testing, including comprehensive genomic sequencing.

As a result of recent technological advances, it is now possible to simultaneously and comprehensively sequence both mitochondrial and nuclear genomes. However, the very recent introduction of this technique means that objective research evidence for its applicability to genomic healthcare and how best to integrate it into clinical practice is lacking. Therefore, the second objective of this project is to develop a robust bioinformatic approach for the identification of causative mitochondrial disease mutations.

Inflammation is central to the pathogenesis of atherosclerotic plaque progression and athero-thrombotic vascular events with systemic inflammatory markers correlating strongly with prognosis in acute coronary syndrome (ACS) patients. Indeed, these patients are particularly vulnerable to recurrent ischaemic events in the early post-ACS period, likely driven by pan-coronary inflammation, resulting in a higher prevalence of vulnerable non-culprit plaque.

Moreover, percutaneous coronary intervention (PCI) to treat culprit coronary stenoses in the setting of ACS, is strongly associated with a relatively high rate of peri-procedural myocardial infarction and adverse cardiovascular outcomes, due in part, to distal embolisation of inflamed plaque fragments with microvascular obstruction. Therefore, suppression of atherosclerosis-associated inflammation is of critical importance to stabilise vulnerable plaque (AIM 1); to decrease inflammatory mediator release after PCI of vulnerable lesions (AIM 2); and to reduce plaque progression/instability, which itself is strongly linked with adverse cardiovascular outcomes (AIM 3).

The principle aim of this project is to investigate a new, innovative, and cost-effective approach to reduce the deleterious effects of atherosclerosis-associated inflammation, based on our discovery that oral colchicine, a safe and well established drug, widely used in non-vascular inflammatory disorders, has marked anti-inflammatory properties in ACS patients. Notably, SP’s recent published studies have elucidated that colchicine, within hours of ingestion, markedly reduces (1) secretion of the pro-inflammatory cytokine IL-1β by circulating monocytes and (2) local coronary levels of the inflammatory cytokines IL-1β and IL-18, together with downstream IL-6, a cytokine strongly linked with future coronary events.

Based on these findings, colchicine’s acute effects on plaque stability will be studied, as well as its more long term effects on plaque volume/inflammatory content. Such studies have enormous clinical relevance as they have the potential to directly improve outcomes in patients presenting with unstable coronary syndromes, particular in the context of PCI, as well as ‘stable” patients with established atherosclerosis. Moreover, as colchicine is safe, readily available and cost-effective, it can be rapidly included as part of the standard therapy for both ACS and stable coronary disease patients.

Delirium, a transient confusional state, is an increasing problem for Australia’s ageing inpatient demographic. Incidence rates from international studies range between 3-29 per cent for patients over 65 years, equivalent to 116,731 – 1,128,400 inpatients using Australian 2013-14 admissions data.

Higher rates of 47-63 per cent have been observed in surgical patients over 65 years, and critically ill patients with delirium have substantially higher prevalence rates (up to 70 per cent) and longer hospital stays (by 6.5 days). Delirium has a significant health impact as inpatients developing delirium are 2.6 times more likely to die during admission, and have a higher risk of developing dementia (adjusted relative risk of 5.7, CI 1.3-24.0). The presence of pre-existing dementia increases the risk of developing delirium two to five times.

A key factor for this research is that delirium is largely preventable, using evidence based guidelines for implementing pharmaceutical, physical, and care delivery changes to inpatient care. The Australian Commission for Safety and Quality in Health Care is releasing a new Delirium Clinical Care Standard (Standard) in 2016 which incorporates this multi-component approach. This is therefore a critical time to investigate and evaluate the impact and effect size of implementing the new Standard, whether the Standard is being implemented as planned, and whether the Standard is effectively addressing the need to identify, prevent and treat delirium.

This study will provide critical data for assessing the benefits to patients and cost-savings gained through preventing and treating delirium in a rapidly ageing population, using a novel combination of applied health economic and implementation science principles. Delirium incidence rates in study hospitals will be measured before, and after, the implementation of the multi-component intervention that forms the basis of the Standard. In addition to standardised clinical outcomes, the study will assess barriers and enablers to the implementation and provide vital feedback to policy makers to understand and improve translation of the evidence based guidelines into practice. Despite existing research on the design of the multi-component interventions, the financial impact of delirium to the health system, and effectiveness of interventions for clinical outcomes, the unique contribution of this study is in determining the cost-effectiveness of these multi-component interventions in Australian acute care and the factors that ensure success.

3D Fractional Moving Blood Volume is a non-invasive measurement of perfusion using ultrasound. This technology combines medical image analysis and power Doppler ultrasound, to enable a sonographer or doctor to evaluate the amount of blood flow (perfusion) in a particular organ, tissue or tumour. This technique provides a marker of organ function and can detect change over time. The technology uses machine learning and image analysis to automatically and in real-time generate a value of blood flow in a given area that compensates for differences in machine settings, depth and attenuation.

Having understood the challenges of commercialisation of this device, I intend to continue its development to provide strong clinical evidence of its efficacy. In parallel with this, I intend to work with partners at public clinics and eHealth NSW to understand potential cross-over in image collection and analysis at a State level.

Congenital heart disease is associated with high levels of morbidity. At least a third of patients born with congenital heart disease will require one major open-heart operation. Often, this heart surgery involves construction of a valved conduit connecting the right ventricle and pulmonary artery to repair complex defects. Current modalities for tissue repair are homografts (from cadaver) and xenografts (from animal). Both have shortfalls in biocompatibility and durability, and most importantly, growth potential. As such, paediatric patients require up to four operations to replace the conduit throughout childhood and adolescence.

At TrueHeart, we aim to overcome the key complication of reoperation through the research and translation of novel medical implants. We have conceptualised a tissue engineering solution that utilises bespoke implant fabrication and 3D printing. This technology will allow us to improve the health are outcomes and quality of life for young patients affected by congenital heart diseases.

During the Medical Device Commercialisation Training Program, we have developed a straightforward business model canvas for this technology. In the next 12 months, we will focus on two aspects of this technology. From a technical point of view, we need to conduct large animal studies to prove the functions of the designed biomaterial. On the business side, we need to continue interviewing potential customers and key partners to finalise the business model canvas boxes.

Device-related infection represents a significant public health issue and financial burden on governments around the world. Antimicrobial coatings based on antimicrobial peptides and quorum sensing inhibitors were developed by our group at University of New South Wales to prevent such infections.

Quorum sensing is a cell-to-cell communication mechanism between individual bacterial cells, which coordinates gene expression and behaviours for bacteria cells in close proximity.

Our antimicrobial coatings have broad spectrum activity against bacteria, including drug-resistant strains, as well as fungi and protozoa. The coating could be applied to a variety of materials such as polymers and metals, making it suitable for a range of applications such as contact lens and implants.

The antimicrobial coatings are composed of two classes of bioactive agents, antimicrobial peptides and quorum sensing inhibitors with unique advantages over current antibiotics. Antimicrobial peptides are nature’s defence against bacteria found in humans as well as a variety of animals and plants. These peptides act primarily through the disruption of bacteria membrane, which bacteria is unlikely to develop resistance for, leading to cell death.

I would like to apply all the things I’ve learnt in the Medical Device Commercialisation Training Program to make the technology into a viable business. In the next 12 months, we will look to conduct further experiments and product development to gather data to satisfy the substantial regulatory approval process required for the future.

StandingTall is an engaging home-based exercise program using mobile technology for preventing falls in older people. StandingTall runs on any tablet device and can be used at home. It is tailored to the user’s ability and utilises advanced algorithms to progress difficulty over time. Because of this and the large variety of exercises, it is motivating and effective.

Now that I have completed the Program, I plan to revisit some of the topics. I will perform additional customer interviews to validate my current business model. These steps will allow me to advance the business case for StandingTall and put us in a good position to seek funding.

With a current world population of 900 million people aged 65 and over, a number that is expected to double by 2050, injurious falls and their prevention are a major, and growing societal issue. Implementation of cost-efficient and scalable fall prevention, such as StandingTall, is timely and urgent.

The Allegra Orthopaedics fully synthetic spinal cage, works to regenerate bone under spinal load conditions and be completely resorbed by the body, leaving it and the intervertebral space free of foreign materials. This is a one-of-a-kind innovation.

The device is 3D-printed from a synthetic bone bioceramic (Sr-HT-Gahnite) invented at the University of Sydney and licenced globally by Allegra Orthopaedics. The synthetic bone possesses the mechanical strength required for load-bearing conditions, bioactivity needed for outstanding bone regeneration, and resorbability that reduces the risk of rejection and infection all in a customisable structure. No bone graft is required as the device material induces bone graft.

Over the next 12 months I will continue with my customer interviews and discussions with surgeons who are supportive of the technology. My key goal is to design and implement much of the pre-clinical studies.

SIXTH SENSE – Your Balance Right tests peripheral vestibular (balance) function. If you have ever had motion sickness or alcohol poisoning, then you may have experienced a balance sensor dysfunction. For vestibular patients these acute symptoms last weeks and chronic symptoms can be permanent and notoriously difficult to diagnose. Patients are incapacitated and terrified they have a brain tumour, a stroke, are dying or ‘going crazy’. Patients go from general practitioner to neurologist to rehabilitation for years, with no diagnosis or the wrong diagnosis (migraine, depression, mental illness) in some instances.

Around four per cent of adults report a chronic problem with balance and 35 per cent of adults 40 years and over have experienced vestibular dysfunction. For older people (aged 65 years and older), 80 per cent have experienced dizziness.

Sensory disorders are a large health burden. The dominant test for the last 100 years, caloric irrigation, evaluates only two of 10 sensors. In 2009, we published one of our dozen vestibular testing tools (vHIT) that evaluates six sensors. Our new device, Micro Vestibular Evoked Myogenic Potentials (uVEMP), tests the remaining four sensors. Together vHIT and uVEMP can test all 10 sensors.

Coeliac disease is a condition in which the body’s immune system is unable to properly process gluten – a protein found in consumed wheat, barley and rye. It causes inflammation and damages the small intestine, and if undiagnosed can lead to small bowel cancer.

Coeliac disease effects on average one in 70 Australians. Around 80 per cent of coeliac sufferers are undiagnosed as many symptoms are similar to other disorders.

Our team has developed a noninvasive test to screen for coeliac disease by simply using saliva and obtaining a result within minutes. Our saliva-based test offers a cheap, accurate, simple and safe point-of-care test that could potentially be available to the general public and clinicians.

This Program has helped us to shape our idea and create a solid evidence for the need of our technology. We will put into practice all the skills the Medical Device Commercialisation Training Program has equipped us with and start our commercialisation journey.

We leave Cicada with a better understanding of our market and the network of people who can help us navigate the next 12 months.

InKardia is a dream that started over 10 years ago in the United States and is based on the development of the biological ink (or “bio-ink”) that acts as a mini-human heart tissue in a test tube. This technology starts from understanding how the heart develops in nature and uses patient-derived stem cells. The bio-ink is used to build human heart tissues using a “bioprinter” that 3D prints, layer-by-layer, within a cardiac-tailored bio-paper (“hydrogel”). Patient-specific bioinks are used as diagnostics for cardiovascular disease patients or to prevent side effects. Bioprinted heart tissues are also used to treat heart failure in patients that cannot receive a heart transplant.

In Australia, only 95 out of over 13,000 heart failure patients received a heart transplant in 2015. Given the calibre of the potential market for this technology and the lack of heart transplants available for patients, in the next year my main goal is to establish a company based on this novel technology, and seek funding to support clinical studies. I will also look to partner with experts with different skills in the commercialisation of medical devices to take with me in this long journey.

Respia is an asthma management system that tracks and records the wearer’s respiratory health. It’s a wearable patch for children with asthma that detects early signs of asthma before they become noticeable symptoms or worse, asthma attacks. It’s a communication link between parents and children with asthma. Our goal is to reduce the number of preventable hospitalisation events for kids with asthma. In doing so, we will save children from trauma, parents from stress, and the public health system money.

In the next 12 months Respia will open a seed round of funding. We will use this funding to build a higher fidelity prototype for upcoming clinical studies and trials. Respia is also looking to strengthen its management team with business and regulatory expertise.

The long-term vision of Respia is to provide preventative health solutions to markets where reactivity is the established norm. Respia wants to help parents understand their child’s asthma and make informed decisions on how to best manage the condition.

Rheumedica is a precision medicine company that is transforming the way we diagnose patients with autoimmune arthritis. The company has made a ground-breaking discovery that explains the pathological mechanisms involved in autoimmune arthritis. The device is a companion diagnostic to the current test and the first specific test for these patients. This technology has greater accuracy compared to the current test which has on average a 30 per cent false-negative result. This is the only specific test which is accurate and specific to autoimmune arthritis.

Over the next 12 months we will work in collaboration with rheumatologists and dermatologists to complete a clinical trial using our technology. We will publish the results in a reputable journal and apply for compliance/registration of the technology in the main continents. We will work with our early market adopters to achieve market share and partner with an established company to distribute our technology.

We are establishing a new service to test for human papillomavirus (HPV) and vaginal microflora for women to take their own vaginal swab samples in the privacy of their own home. Self-sampling is a simple procedure which involves collecting a vaginal sample by the woman. After collection, the sample is sent to a registered pathology lab for testing with the results sent to the woman via a general practitioner. This provides an alternative to presenting at a doctor’s office in managing a woman’s vaginal health and can increase the detection of HPV by encouraging more participation in screening.

My goal after completing the Medical Device Commercialisation Training Program is to gain more knowledge about business. As most ambitious people, I came into the course thinking that I could be an entrepreneur and start my own business. The course has made me recognise that in order to be a successful entrepreneur I need to obtain specific business knowledge and develop my skills, which is now my goal for the coming year.

The invention is a bioresorbable subdural drain to be used for the treatment of chronic subdural haematomas. The drain design includes a z-bend in the cranial end for ease of insertion through a burr hole, bioresorbable tubing to be tunnelled through subcutaneous tissue to land within a pouch formed for drainage and interstitial absorption. This drain will reduce recurrence rates of chronic subdural haematomas, the need for surgical revision, allow patients to move soon after the procedure, and reduce the overall hospital length of stay.

Over the next few months my goal is to continue working on a viable prototype which will eventually be implanted and trialled. If the drain proves viable and becomes the standard for treatment of chronic subdural haematomas, I would like to see its possible applications expanded beyond neurosurgery into other surgical specialties.

A diagnosis of a brain disorder is often made worse by the lack of effective treatments and the substantial side effects of current treatment. Despite over 200 million people facing this problem, many companies have stopped developing new brain disorder treatments. Current methods for predicting the effectiveness of brain disorder drugs have shown to be of little help, with failures costing the industry many hundreds of millions of dollars in the past decade.

VitroQuest is addressing this problem by providing a drug validation service built on the actual human disease biology to test ineffective treatments early in development. By using our validation platform, drug developers will reduce the risk of future efficacy failures and increase their confidence in the remaining treatment candidates. This will improve the financial viability of developing brain disorder treatments.

The Program content together with the learnings from the customer discovery interviews has given me the confidence to bring this technology to the market. I am confronted daily by the desperate need for better treatments of brain disorders. I believe I can help improve this dire situation by putting all my energy into making this technology available to drug developers.

Proton-X is a revolutionary patient positioning system for use in proton therapy systems. This patient positioning device integrates into current Proton therapy systems. It introduces two major changes to proton therapy:
- positioning the patient in an upright position from the horizontal plane delivers better clinical results and allows proton vendors to fix their radiation beams, and
- rotating the patient rather than the machine reduces infrastructure size and cost.

Having completed the Medical Device Commercialisation Training Program, I have strengthened my commercial skills along with my overall understanding of how product development fits within the wider business context. Over the next 12 months I would like to take the business model canvas developed during this course and expand on it, working with a proton therapy vendor to strengthen the business case for upright proton therapy.

The end goal will be to see an upright proton therapy patient positioning device delivered to the market through an Original Equipment Manufacturer relationship between Leo Cancer Care and a leading proton therapy vendor.

Watery, blurry, red, itchy or dry eye, are all symptoms of dry eye disease. This disease is caused by the tears of the eyes not forming an effective protective film over the eyes after blinking. In severe cases, this diminishes the quality of life to the same level as having a badly broken hip. Confirmation that these symptoms represent dry eye
disease is difficult because it is a complex disease with multiple causes and current diagnostic tests for dry eye disease are not effective. Even though dry eye disease
affects 15 per cent of the population, 82 per cent of clinicians believe it is under-diagnosed. As diagnosis is a problem, treatment is generally a best guess for a particular tear substitute and the treatment cannot be monitored objectively. TearView breaks this cycle because it enables visualisation of the tear film in real time which can be used to determine the nature of the dry eye disease. Consequently, the treatment can be targeted and the effects of treatment can be objectively observed and evaluated. The ability of TearView to see the tear film means that it can also be used for diagnosis of other eye problems that affect the tear film.

Focal therapy is a well-established technique of targeting and treating benign and cancerous lesions throughout the body. It has been used for years for brain, lung, liver,
bladder, pancreas and kidney cancers. In recent years more powerful MRI (magnetic resonance imaging) machines have become available and enabled clinicians to
visualise prostate cancer for the first time. The visibility of these cancers with MRI has enabled the development of ProFocal-Rx targeted laser therapy. ProFocal-Rx allows
for at least 30 per cent prostate cancer patients to have minimal invasive therapy instead of surgery or radiotherapy. It also allows curative treatment and peace of mind for patients who would have chosen active surveillance for their prostate cancer.

The ProFocal-Rx laser delivery unit is introduced in the proven abnormal cancerous area. ProFocal-Rx allows for real-time interactive treatment ensuring that the cancer is
eradicated and ablated. The treatment is performed as a short outpatient procedure with the patient going home the same day. The side effects of the treatment are less
than the diagnostic biopsies that are currently performed.

Blount’s disease is a form of bowleg, which means that as a child grows their tibia grows at a different angle to the rest of their leg. It is a progressive disease, meaning surgical intervention is required to prevent the deformity getting worse. Currently, if the child is older than around four years, the treatment of Blount’s disease involves an osteotomy, or cut in the bone, with a gradual correction using an external fixation frame. These frames are bulky, uncomfortable and require a significant and costly four to six month commitment on behalf of the patient, family and healthcare team.

The Blount’s plate is an orthopaedic plate that can be used for the internal correction of Blount’s disease. This approach transforms the surgical management of Blount’s disease into a fully internal one, meaning that there is no need for an external fixation frame. The Blount’s plate would give the patient the freedom to play as a child without the restrictions of an external frame. This plate has the potential to save the healthcare system from 4 to 6 months of intensive outpatient follow up care, including appointments with the surgeon, radiology, physiotherapy and a specialist care nurse. This plate has the potential to improve the experience and effectiveness of patients being treated for Blount’s disease without sacrificing quality of care.

Two out of every three Australian women are overweight or obese, equating to 6.5 million women nationally. Research shows that women who are overweight or obese have 2-3 times the breast volume of women of a normal body mass. With a limited range and availability of bras designed to cater for these larger sizes, this can lead to problems finding a bra to both fit and sufficiently support their breasts during exercise. As a consequence of ill-fitting or unsupportive sports bras many women with large breasts are not gaining sufficient support from their sports bra. This can lead to pain and embarrassment during physical activity and can be a barrier to participating in physical activity. Removing the bra-barrier to physical activity for overweight and obese women with large and hypertrophic breasts is important from a public health perspective in order to enable these women to enjoy the benefits of physical activity, which in turn leads to improved health outcomes.

BraVo Sports Bras provide a better solution by using accurate and detailed three-dimensional body scan data of the breasts and torsos of women in conjunction with a deep biomechanical understanding of how the breasts move during motion. That is, sports bras specifically designed to comfortably fit and support the breasts of overweight and obese women with large and hypertrophic breasts.

Current methods of obstetric monitoring are cumbersome, restrictive and rely on subjective interpretation which is known to increase intervention. This poses a problem for mother and baby, clinicians, hospitals and health systems. When a mother is monitored with current methods it can be a distressing experience, compromising her comfort and mobility while impacting outcomes for herself and her child. Subjective interpretation of data often results in inappropriate and late intervention, requiring substantial resources, placing significant burden on the health systems.

Oli is a non-invasive patch which monitors pregnancy and labour progression. The technology allows for more objective measures to identify complications, assess intervention performance and improve outcomes. Oli provides real time feedback on uterine activity, maternal and fetal well-being, exertion, movement and how these all correlate to progression. Oli allows for remote monitoring without impacting maternal activity.

One in six couples worldwide experience infertility and approximately 3-4 per cent of all babies born in most western countries are the result of advanced assisted reproductive technologies, such as in vitro fertilisation (IVF). Despite its widespread use, IVF remains inefficient with only a 17.9 per cent success rate (live birth/IVF cycle initiated) , and it is expensive. Egg (oocyte) quality is one of the key ratelimiting factors in IVF success.

Joi is the world’s first non-invasive in vitro diagnostic test that directly measures key biomarkers produced by the oocyte from multiple biological samples. By better selection and implanting a healthy egg, it is anticipated that the success rate in patients undergoing IVF treatment will be improved. Compelling evidence has been generated using a variety of clinical samples from healthy volunteers and patients with ovarian diseases. In addition, to assessing the quality of oocyte, this test may also be used to estimate the quantity of eggs available and to diagnose certain ovarian diseases such as endometriosis.

Exoskeletons promise to significantly improve the daily lives of the sufferers of paralysis, if they can be made easier to control. Spinal cord injuries are relatively rare in Australia, but they often occur to young people leading to lifelong disability. The direct costs to the healthcare system are consequently very high, estimated at more than $10 billion for cases that occurred in this year alone (Access Economics “The economic cost of spinal cord injury and traumatic brain injury in Australia”). The indirect costs to families and caregivers are even higher. XoCo is developing a closed loop neuroprosthetic controller for a lower body exoskeleton, to assist with balance and gait coordination during operation by spinal cord injured users.

With an ageing population and a growing number of people living with chronic or complex health conditions, people’s health needs are changing and demands on the health system are increasing. health.ly, a digital integrated healthcare platform, creates better connected models of healthcare that improves outcomes for health consumers by making it possible to access high quality care - anytime anywhere. health.ly improves health outcomes by providing patients with a more convenient and personalised service through informing, educating, and supporting treatment adherence. It helps with sharing of clinical information between hospitals, specialists and general practitioners, and reduces unnecessary duplication of pathology and radiology tests.

The technology also allows patients access to high quality cost efficient healthcare at home by using digital communication such as e-visits, e-prescriptions and two-way remote monitoring. As a result more patients can be cared for in the community with a reduction in avoidable hospitalisations and emergency department attendances. The patient experience is improved by enabling the right care to the right patient at the right time – each time and every time.

Incontinence affects over 5 million Australians with one in three women and one in four men over the age of 50 suffering from loss of urinary and/or faecal control. Within the ageing population, incontinence is highly prevalent affecting up to 70 per cent of all geriatric patients in residential age care and in-home community care. The problem of incontinence is not limited to the symptoms of urgency, frequency and night time waking to relieve urinary and faecal urges. It is often the loss of dignity patients feel when they are forced into managing their incontinence with adult diapers. Pharmaceutical options are often unsuitable due to polypharmacy interaction and side effects. Surgical treatment is invasive and comes with significant risk.

InConfidence is a discreet, non-invasive, wearable medical device worn around the ankle for twenty minutes a day. It works through transcutaneous electrical stimulation of the posterior tibial nerve found on the ankle. The posterior tibial nerve is a peripheral nerve of the sacral plexus which innervates both the bladder and bowel. Stimulation of this nerve normalises the neural communication between bladder/bowel and the brain. Just like a phone call on a clear line, the brain is able to ‘hear’ exactly what the bladder and bowel are trying to communicate and restore normal continent function in the patient.

Modern radiotherapy techniques allow highly conformal radiation dose delivery to cancer. Accurate positioning of patient/tumour during the delivery of treatment is paramount to ensure the correct dose is delivered to kill the cancer cells and avoid damage to nearby normal tissues. However, the tumour position during radiation delivery can be affected by patients’ involuntary movement and the motion of internal organs. Real time tumour position monitoring ensures the accurate positioning of the tumour during radiotherapy delivery. General purpose linear accelerators (radiotherapy machines) do not have this functionality.

RO-TrackerSuite is a software system that enables the real time tumour position monitoring functionality in a general purpose linear accelerator that comes with standard x-ray imaging capability. With RO-TrackerSuite, real time tumour position monitoring can be performed for the majority of treatment sites such as prostate, liver, pancreas, lung, brain and spine. RO-TrackerSuite has the functionality to perform real time position monitoring based on the radiopaque markers implanted in or in the vicinity of tumour. In the treatment sites where implants are difficult or not possible, RO-TrackerSuite has the functionality to perform real time position monitoring based on the internal anatomical surrogates that are closer to tumour.

More than 10 per cent of men experience prostate cancer in their lifetime. The prostate-specific antigen (PSA) test is the current golden standard method of prostate cancer detection. However, more than of half of PSA tests produce false-positive results which cause stress and anxiety in patients as well unnecessary biopsy examinations.

PC Diagnostics aims to revolutionise the way that prostate cancer detection and therapy are managed by introducing a urine test for the detection of the disease. This technology will avoid many unnecessary biopsy examinations by presenting more accurate results. This is important to reduce the psychological pressure on men who are screened for prostate cancer as well as avoiding unnecessary costs of biopsy tests. Development of this technology will also promote more regular check ups by men and may lead to earlier detection of cancer promoting more active surveillance. Solutions for more advanced prostate cancer are such asradiotherapy and surgery cause such as urinary incontinence and sexual dysfunction. The application of the PC Diagnostics technology will utilise simple urine tests for prostate cancer detection and will promote regular and more accurate prostate cancer screening.

According to the World Health Organisation’s Vision 2020 report, there are approximately 300 million visually impaired people in the world. In Australia alone, there are more than 2 million visually impaired people with nonrefractive eye conditions. These conditions obstruct the view, create blind spots or loss-in-detail at different locations of the eye. Due to the complex anatomy of the eye, the nervous system and how they interact together, an effective medical treatment has not yet been developed. However, technological advancement can offer an alternative pathway for people suffering from visual impairment.

SOOMA is an electronic vision enhancement device developed specifically for legally blind people who suffer from visual impairment. SOOMA is designed as a modular electronic eyewear capable of producing individually customisable images. Live videos are captured by cameras mounted in the eyewear which, through a novel near real-time image processing procedure, is then displayed in front of the eyes. This is a practical solution for addressing non-refractive eye conditions to meet the needs of individuals from childhood to adulthood.

Patients who are granted access to the clinical notes prepared by their doctor during a consultation report a greater sense of control over their healthcare and a better understanding of their health. Kyyron offers people the ability to regain a sense of control of their healthcare by helping them to manage their health and medical data.

Initially, the product is targeted at informed health consumers who either have chronic or complex health needs, or care for a person who does. The app will provide these individuals with the ability to keep track of, and prepare for, their multiple healthcare appointments, with multiple doctors and providers. It will also provide a place to make notes and collect the results associated with these appointments. This information will then be readily available to the individual, or a healthcare provider they share the information with, whenever and wherever it is needed.

Over time, the app will expand to become a personal, historical record of individual health, bringing together a personal copy of official medical records alongside the individual’s own notes and insights, to create a single, centralised repository of an individual’s health and medical data.

One in four young people in Australia suffer from mental health disorders such as depression. Further, around half of all adult mental illnesses emerge by the age of 15. Failing to address these issues in adolescence is associated with more severe clinical presentation throughout life, as well as poor academic performance, social dysfunction, substance abuse and suicidal thinking. As the human, social and economic consequence of this can be devastating, mental health is one of the greatest challenges of the 21st century. While there is considerable evidence to demonstrate that early intervention can dramatically change the course of an individual’s mental health trajectory, up to 60 per cent of young people will not seek help. The stigma associated with mental illness prevents many from reaching out, along with accessibility and cost of existing best practice treatment - face-to-face psychological therapy.

Delivering early intervention strategies to young people using technology will remove these barriers. Smartphone use is ubiquitous with more than 80 per cent of young people owning their own phone. As such, the Black Dog Institute developed an app that delivers best practice psychological therapy. The app focuses on sleep problems, a common precursor to the development of depression, which is less stigmatising and more appealing to young people. By utilising gaming technology to engage young people in treatment, the app overcomes existing barriers to help-seeking and ensures support is available 24/7. With young people preferring the privacy, anonymity and interactivity that this technology allows, this app will be key in preventing the emergence of mental health symptoms during the critical adolescent period.

Heart disease kills one Australian every 27 minutes. Heart attack as an endpoint of heart disease is unpredictable. During a heart attack, heart muscle is damaged as it is deprived of its normal blood supply. The extent of damage depends on severity of heart attack as well as the time between the attack and treatment.

Condicion is a non-invasive medical device that exercises the heart and stimulates the release of endogenous substances into the bloodstream that reach the heart to exert heart-protective effects. This may prevent damage to the heart muscle, or limit the extent of the damage during a heart attack.

The device can be used at home while sitting or lying down to prevent heart attacks. It can also be used in ambulance during patient transport to hospital to reduce the extent of heart damage following a heart attack. Another application of Condicion is in pre- and postoperative care of patients undergoing a heart procedure.

Currently CT scans are used to design and deliver radiotherapy treatments for cancer. However, MRI scanners provide more superior tumour and normal tissue imaging. Being able to use MR images in radiotherapy treatment and planning will allow the delivery of more targeted radiotherapy to cancers while reducing the impact on normal tissue. The technology required to combine a linear accelerator radiotherapy machine and an MRI scanner is complex and challenging.

MRI-Linac technology is working on a prototype combining a linear accelerator radiotherapy machine and an MRI scanner in order to deliver more targeted radiotherapy to cancers while sparing normal structures nearby. With $27 million of grant funding and world class research MRI-Linac technology is well placed to contribute to the future of radiotherapy treatment and transform the lives of cancer patients.

Over half of NSW adults are overweight or obese and this is now the second leading risk factor of disease in NSW, ahead of smoking. Malnutrition is also a major concern in requiring regular monitoring as it increases healing times, costs and readmissions.

This device provides an accurate measurement of percentage body fat in an instrument which is much smaller, safer and easier to use than comparably accurate devices that are much less practical.

Using IP developed at the University of Sydney and support from the Bill and Melinda Gates Foundation, the device has been validated against gold standards in over 650 participants. This device and service will aid dieticians, fitness instructors, nurses, and medical practitioners to address the clinical conditions of obesity, overweight and underweight.

The motivational way in which information is presented will increase adherence by participants and allow caregivers to track and provide quantified information on nutrition and exercise management. This will allow improved management of obesity and other clinical nutritional issues where optimised nutrition is desired including cancer care, paediatrics, aged care, intensive care, pregnancy, and eating disorders. Through better management quality of life will be improved and health costs reduced by reducing hospital readmissions and chronic disease.

One in three people in Australia die of cardiovascular disease. The underlying process causing the majority of these deaths is atherosclerosis. Atherosclerosis is a disease where fatty material is deposited in sections of the wall of the artery. Deaths occur when local atherosclerotic lesions rupture, stimulating clot formation, leading to occlusion of the artery. These lesions are termed ‘vulnerable plaques’. Both heart attacks and strokes can be caused by vulnerable plaques rupturing. Recent research has shown that vulnerable plaques can be identified prior to their rupture. The Stabilyzer device provides treatment that will prevent future heart attacks and strokes with the development of a locally applied treatment to stabilise these plaques.

The rise in rapid prototyping technologies has presented a unique opportunity for the creation of custom made implants. However, the logistical shift from generic high volume production systems to individually customised implants prevents its widespread usage. The Rapid Templating System aims to form patient specific implants quickly and effectively. The system involves the production of a 3D-printed guided mould, based on patient scans, to shape terminally sterilised generic materials into patient-customised implants. The generation of custom implants within packaged materials allow implants to be immediately ready for use, avoiding treatment delays due to sterilisation post production. This approach has the capacity to significantly reduce inventory costs for medical device companies, as abundant implant-size ranges are no longer required to accommodate all patient cases. Further developments in regenerative medicine may allow further customisation material properties, allowing the implant to be patient specific anatomically as well as a biomechanically.

Endoscopic retrograde cholangiopancreatography (ERCP) is an endoscopic procedure that allows access into the biliary system and has revolutionised the management of bile duct pathology. However, it is a notoriously difficult procedure to learn and even in experienced hands, this procedure is associated with complications including pancreatitis, bleeding, perforation and in rare cases, death. Cannulation of the bile duct remains the most challenging step of the procedure even with current sphincterotome technology. The Pivot Sphincterotome has been developed to facilitate easier, faster and ultimately safer biliary access. The ERCP sphincterotome US market alone is worth approximately $USD150 million and with an increasingly elderly population requiring less invasive procedures, it is expected to increase. Developed by an ERCP practitioner, the Pivot Sphincterotome aims to accommodate the shortcomings of current technology making the ERCP experience more user-friendly, efficient and safe.

To develop and commercialise a novel universal screening test for the detection of breast cancer that is highly accurate, safe, cost effective, and available to all women regardless of age, race and geographic location.

Breast cancer is the most common cancer among women, therefore, the effectiveness of the screening and diagnosis technology used is a high priority. The current model relies on a woman being physically present at a clinic for breast imaging which is not always convenient. While the present technologies are currently state of the art, there is a high cost involved. There are also well known performance limitations that result in only a small subset of women who are actually eligible for screening.

BCAL Diagnostics aims to shift the paradigm in breast cancer screening and diagnosis by introducing a blood test for detection of the disease. The implication of such a technology could revolutionise the way breast cancer is managed by allowing a blood sample to be taken remote from the site of analysis. This technology will allow access to more women, anywhere in the world, who could provide a blood sample, at a time and place convenient to them. Such a test would fit into a woman’s routine health regime and be incorporated into their personal lifestyle. In addition, with such high levels of accuracy, this technology would provide greater peace of mind between annual checks. The BCAL Diagnostics technology could utilise a single blood test on multiple levels for disease prevention, diagnostic mass screening and postintervention.

Mitral regurgitation is a condition caused by a leaking heart valve and affects more than four million individuals in the USA. The standard method of fixing valves is with open heart surgery, a complex operation performed on cardiopulmonary bypass. The operation is expensive, and recovery time from the operation is measured in weeks or months. The SeCure Beating mitral heart repair device enables heart valve repair while the heart is still beating, with no need for bypass or long anaesthesia time or surgical scars. Patients can recover in hours or days and the cost of surgery can be dramatically reduced. The heart repair can be repeated if necessary and conventional surgery can also be performed at a later date. With the new technology many patients who have been deemed unfit for surgery could be given life saving treatment.

Backed by experts at the University of Wollongong and Swinburne University of Technology, Geldom is helping make condoms more wearable by replacing latex with better feeling materials called tough hydrogels. These tough hydrogels are superior to latex and can improve the experience by offering more tissue like sensation. They also have other revolutionary benefits – no bad odours or tastes, no latex allergies, inherent self lubrication, and can even be embedded with anti-sexually transmissible infections agents or stimulants.

These new options have the potential to dramatically increase condom use. The impact – not only redefining what safe sex should feel like – but the added social benefits of improved family planning and disease prevention.

This work is geared towards disrupting the $6 billion condom industry desperate for innovation. This patent pending work has been supported by the Bill & Melinda Gates Foundation and has featured on ABC’s Catalyst.

CardioFlex is the next generation of cardiac pacemaker leads. Conventional pacemaker leads are comprised of a long, coiled metal wire running from the neurostimulator to the electrode implanted in the heart. These conventional leads are prone to infection, dislodgement and mechanical failure. They are also incompatible with MRI because they act as antenna and generate unsafe amounts of heat in the body under MRI. CardioFlex leads do not use metal wires but are instead fabricated from conductive elastomers, a novel material being developed at UNSW. Conductive elastomers allow the CardioFlex lead to be soft, flexible and totally MRI compatible. This means recipients are less likely to require a surgical lead extraction and they do not need to worry about their pacemaker interfering with ongoing or future medical treatments. Other applications of conductive elastomers being investigated include flexible electrode arrays and nerve cuffs for neural interfacing.

This product allows for simple medical testing remotely from home. The home diagnostics kit consists of a small device attachable to a smartphone and together with an app, it allows for the analysis of the same urine dipsticks that are commonly used in the GP’s office. The medical results can then be shared with the GP online instead of going to the doctor, when unwell or busy. This will assist in a comprehensive assessment of the patient’s health problem currently not possible via online consultations. This smartphone diagnostics device also features recording of the test results over time opening up numerous additional applications, ranging from personalised healthcare to new testing methods for diseases.

As the healthcare sector is moving towards a digital platform, these internet connected devices will be essential in the generation of digital medical records as well as the successful implementation of online medical services.

Breathe Well is an interactive medical device that allows breast cancer patients to help improve their own cancer treatment, simply by breathing. In breast cancer radiation therapy, nearby healthy tissues like the heart and lungs are at risk of receiving unnecessary, and potentially fatal, radiation damage. Breathe Well shows patients how to hold their breath to put as much distance possible between the heart and radiation beam to achieve the most accurate breast radiation treatment possible.

One in twenty cataract surgery wounds leak, causing infection and blindness to occur. Sutures cause scarring, are time-consuming to apply, require great skill, and distort vision, In addition to this, patients have poor compliance with postoperative eye drops. Cataract surgery is the most common operation and has the longest waiting list in NSW. Eye surgery costs are rising as the population ages.

Kleer-i is a next-generation “patch”, bonded over an eye wound by a low-powered laser. It falls off once the wound heals. Surgeons will use Kleer-i to rapidly seal eye wounds without sutures, while simultaneously delivering drugs. Kleer-i will save 25 to 40 per cent of operating time and promote faster wound healing, reducing vision loss from scarring, distortion and infection.

Kleer-i is unique in combining drug delivery with sutureless wound closure. It avoids the toxic side-effects and high failure rates associated with existing therapies: sutures, histoacryl glue and fibrin sealant.

Obesity is a growing global health problem with direct costs estimated at $21 billion annually (Australian Diabetes, Obesity and Lifestyle Study). Current therapeutic and policy intervention is not working. Evidence suggests that early directed intervention for individuals with a predisposition to obesity and related co-morbidities is more effective at maintaining long term positive health outcomes. This technology measures the levels of specific modifications to a person’s DNA (DNA methylation marks) that are associated with current or future health status. The core IP is in panels of such DNA methylation biomarkers that could be used to identify an individual’s risk and likely trajectory for obesity and Type 2 diabetes mellitus. This would help direct clinicians, such as endocrinologists and dietitians, in the clinical management of patients and identify at risk people early – reducing the health burden of chronic disease.

Metered dose inhalers (MDI) are a commonly used device to deliver aerosolise medications for the treatment of pulmonary diseases. The emitted aerosols from MDI contain millions of fine particles that carry intrinsic charge that is imparted on them during the atomisation phase. These static charges can cause variations in particle aerosolisation and dosage.

Moreover, the MDI requires manual actuation force to operate and its efficacy relies on patient’s co-ordination between actuation and inhalation, which can be difficult for elderly patients with chronic obstructive pulmonary diseases (COPD). The Electrostatic Metered dose inhalers (EMDI) is a novel electrostatic metered dose inhaler, which utilises electronic force and electrostatic charges to generate inhalable aerosol. It will reduce the need of excipients in the drug formulation to help with the aerosolisation process, and also minimise the difficulties that can occur when using conventional MDIs. EMDI can provide more efficient treatment to people with respiratory diseases, especially for the 65 million patients who currently suffer from COPD around the world.

Kico is currently bringing a customised total knee replacement technology platform to market. The platform has software and hardware components that provide orthopaedic surgeons and patients with dynamic, functional and patient specific solutions. It is primarily aimed at Australian and US markets.

The existing software platform helps orthopaedic surgeons personalise the positioning of the knee implant hardware components. It has been effectively used more than 4000 times in Australia and the US and is playing an important role in the current international debate surrounding alignment strategy selection and patient specific optimisation.

The next step is to accelerate implant hardware developments. The critical differentiated feature of the 360KS hardware program is the mass customisation of the tibial insert component. This allows for optimisation of the articular response between the tibial and femoral components.

Surgeons will be empowered to customise the care regime for every patient with a focus on improving post-operative functional performance. This feature will be unique in the world and is heavily protected by a series of awarded patents.

Company/Organisation Name: Kico Knee Innovation Company Pty Ltd
Public/Private Company: Private
Contact: Bede O’Connor
Email: bede@kneesystems.com
Phone: 0420 688 139

Indee Labs is developing hardware for gene delivery. The hardware is uniquely positioned for the efficient development and scalable manufacturing of gene-modified cell therapies (gene therapies).

The impact of gene therapies will be similar to that of antibiotics seen during the last century. In the near term, gene therapies will provide cures for most cancer cases that would otherwise be terminal, with minimal side effects. In the long term, gene therapies will be applied to other indications such as rare disease and autoimmune disorders.

Current price tags for a cure are higher than the average house in Sydney, and lead times may be too long for patients with an aggressive condition.

For a patient, a typical treatment will involve having blood taken, sent to a facility where immune cells are reprogrammed, before they are reinfused weeks or months later. At this facility, engineered viruses are typically used to deliver new genetic material into a few cells before they are cultured to obtain a quantity suitable to treat a patient. This is a lengthy process and risks associated with it mean that the patient
will need to be monitored for up to 15 years after treatment.

Indee Labs technology uses a mechanical method to deliver genetic material (constructs) into cells as an alternative to viruses. Cells and constructs are passed through a microfluidic chip, which uses microfluidic vortex shedding (μVS) to disrupt the cell membrane allowing new genes to enter. The process is fast, efficient and very gentle on cells. Importantly, it is the only manufacturing technology that has the scale to meet demand for patients who will need a gene therapy in the future.

Ultimately, the technology will make gene-modified cell therapies accessible to the masses.

Company/Organisation Name: Indee Pty Ltd
Public/Private Company: Private
Website: www.indeelabs.com/about-us/
Contact: Dr Warren McKenzie
Email: warren@indeelabs.com
Phone: 0400 059 509

Ellen Medical Devices is building a breakthrough dialysis system which will provide millions of kidney patients around the world access to this life-saving treatment for the first time. This transformation is achieved through a radical reduction in cost.

Dialysis is a safe and effective treatment for kidney failure, ‘but it is expensive, costing $50,000-100,000 per patient annually in Australia. In Australia, dialysis is provided by health care systems. But each year in the developing world, up to 7 million people die because dialysis is too expensive for them to access.

The system employs peritoneal dialysis. It is pain free, portable and solar powered, using water from any source, it meets all safety standards. This costs just $1,000 to build and $5 a day to run.

Traditional peritoneal dialysis requires manufacturing bags of fluid at a central sterile manufacturing site, then transport across long distances at high cost. This system fills the bag at the point of care, eliminating manufacturing and transport costs, creating a new low-cost business model.

The machine can be used at home or by rural health workers in remote settings. It will save lives, create a new global business for NSW, and reduce costs – wherever dialysis is needed.

Company/Organisation Name: Ellen Medical Devices Pty Ltd
Public/Private Company: Private
Contact: Professor John Knight
Email: jknight@georgeinstitute.org.au
Phone: 0414 614 189

Trimph Technology Pty Ltd is an Australian biomedical company that has developed a platform technology to repair bone, cartilage and connective tissues. The properties of this material can be tuned to treat a number of pathologies including osteoarthritis, bone injuries and soft tissue defects.

Since Trimph’s incorporation in August 2015, the company has established its own ISO13485 accredited production facility, received granted patents in the US and Europe and completed a first-in-man trial for a dental application. TrimphDent is the company’s first product to be used to accelerate hard and soft tissue healing post tooth extraction.

Tooth extraction is an inherently traumatic procedure that damages the underlying tissue and leads to inevitable jaw bone shrinkage. Clinically, loss of alveolar ridge bone results in aesthetic and functional
complications as well as the need for a secondary invasive operation prior to prosthetic placement.

TrimphDent is a ready to use, injectable scaffold that is applied immediately after tooth extraction and has been shown to preserve the socket in a pilot clinical trial. Unlike all other bone substitutes, TrimphDent is delivered to the extraction socket as a liquid, and quickly forms an elastic matrix at the site to provide a predictable platform for bone regeneration. TrimphDent requires no specialised preparation, socket packing or additional surgical expertise. These unique properties save time for surgeons and allow more general dentists to perform the procedure.

Improving access to dental services is aligned with the vision of both State and Federal health Governments. Bone anchored prosthetics improve quality of life by allowing better mastication and speech and improving general health outcomes. However, economic barriers and poor access to specialist oral surgeons are recognised limitations to the widespread use of implant secured prosthetics.

With the aid of NSW’s Medical Devices Fund, Trimph will run a clinical trial and complete the requirements for European and Australian registration.

Company/Organisation Name: Trimph Technology Pty Ltd
Public/Private Company: Private
Contact: Dr Ali Fathi
Email: ali.fathi@trimph.com.au
Phone: 0413 721 939

iFix Medical, a NSW consortium of researchers, surgeons and industry have developed a novel medical treatment technology that incorporates 3D printing for corneal diseases and injuries.

The cornea is the clear window at the front of the eye, and corneal disease is the third most common cause of blindness worldwide. Corneal ulceration is extremely painful and accounts for 55,000 presentations to hospitals each year across Australia. Current medical treatments do not adequately address issues of pain relief, infection or the development of scar tissue. Infection and scarring may necessitate lengthy
hospital stays and further treatment.

The iFix system can be used to deliver a 3D-printed structure directly onto the eye to treat defects. It comprises of two components: iFixInk™ and its delivery device, the iFixPen®. The system involves the printing of a transparent structure that seals the wound and prevents pathogen infiltration. It relieves pain, accelerates healing and is biodegradable. The ink formulation can be tailored to clinical need and can
contain antibiotics and or other active regenerative agents.

The iFixPen is a handheld 3D-printing device, which can deliver the “ink” to the defect with high accuracy in a smooth and effective manner. The delivery process takes less than two minutes.

Company/Organisation Name: iFix Medical Pty Ltd
Public/Private Company: Private
Contact: Dr Gerard Sutton
Email: gerard.sutton@visioneyeinstitute.com
Phone: 0414 416 194

Eudaemon Technologies is creating the next-gen condom made from innovative materials called tough hydrogels. These tissue-like materials perform like latex rubber but with enhanced feel, self-lubrication, have no adverse odours or tastes, and do not cause allergic reactions.

Condoms are the only medical device that can simultaneously prevent pregnancy and sexually transmitted infections (STIs). However, condoms are often avoided because of the stigma of reduced sensation during sex. What if instead there was a condom that people couldn’t wait to try? Producing a condom that people actually want to use would revolutionise the definition of safe sex, enhance family planning
(reducing the 85 million unintended pregnancies per year), support sexual health strategies (reduce STI rates), save healthcare agencies millions worldwide, and disrupt a growing $8 billion global market.

The project will establish the manufacturing and clinical validation to create a market ready product for consumers. Through investment from NSW’s Medical Devices Fund, Eudaemon Technologies will demonstrate the ability to on-shore condom manufacturing in Australia and provide these superior condoms to address sexual health needs in NSW, Australia, and the world.

Company/Organisation Name: Eudaemon Technologies
Public/Private Company: Private
Contact: Dr Robert Gorkin
Email: info@geldom.org
Phone: 0401 071 021

Cenofex Innovations is an early stage medical device company that uses a novel, proprietary ultrasound technology to move fluids within the body. By controlling the output of the individual ultrasonic transducers in the device’s flexible array, acoustic forces are generated and used to move subcutaneous Innovations aims to treat lymphoedema.

Lymphoedema is a chronic and painful disease affecting millions of people. Linked to a poorly functioning lymphatic system, it is characterised by a painful swelling of a limb or body region. Along with pain and discomfort, it can also lead to dangerous infections, restricted movement, depression, poor selfesteem, and an overall poorer quality of life.

Patients therefore, are forced into a lifetime of symptom management. This is made more challenging because existing solutions to symptom management can be painful, taxing, difficult, or overly burdensome. This limits the access most patients have to regular, effective lymphoedema treatment and can lead to even more significant health risks if left unmanaged. There is currently no treatment device that is capable of providing personalised lymphoedema treatment wherever and whenever the patient needs it.

Designed with input from over 200 Lymphoedema Device delivers customisable, pain-free treatment using novel, proprietary ultrasound technology, empowering the user to control and monitor their lymphoedema.

In partnership with NSW Health, Cenofex Innovations will bring to market the only device capable of actively moving lymphatic fluid while incorporating a patient’s need for comfort, portability, and ease. This
unique, innovative technology will transform lymphoedema treatment and return freedom, dignity, and functionality to the millions of patients living with this debilitating condition.

Company/Organisation Name: Cenofex Innovations
Public/Private Company: Private
Website: www.cenofex.com
Contact: Dr Sheridan Gho
Email: sheridan.gho@cenofex.com
Phone: 0476 283 591

Antibiotic resistance in sexually transmitted infections (STIs) is a growing public health issue. STIs have the potential to become the first incurable bacterial infections since the introduction of antibiotics. To address this looming issue, SpeeDx has developed the ResistancePlus product line. These innovative diagnostic tests detect bacterial infection and genetic markers for antibiotic resistance in a single test.

The benefits of combining the testing of antibiotic resistance and detection of sexually transmitted infections include:
(i) patients receiving the correct treatment
(ii) expedited notification of sexual partner(s)
(iii) reduced health care costs
(iv) halting the spread of antibiotic resistant infections
(v) maintaining the efficacy of antibiotic treatment (antibiotic stewardship).

SpeeDx has commercialised the first test worldwide which simultaneously detects a sexually transmitted infection (Mycoplasma genitalium) together with antibiotic resistance. This test enables complex diagnostic information to be obtained from a single, cost-effective, and rapid test, guiding treatment decisions and supporting the antibiotic stewardship of important front-line drugs. Already the benefits are being seen in clinics accessing the tests, with demonstrated improvements in patient cure rates and reduced infection times.

Company/Organisation Name: SpeeDx Pty Ltd
Public/Private Company: Private
Stage/Category: Early and mid stage, In Vitro Diagnostic Device, MedTech
Website: www.plexpcr.com
Contact: Colin Denver
Email: colind@speedx.com.au
Phone: (02) 9209 4170

Focal therapy (or targeted therapy) is a well-established technique of targeting and treating cancerous lesions throughout the body. Focal treatment has been used for years for brain, lung, liver, bladder, pancreas and kidney cancers. In the last 4 years more powerful MRI (magnetic resonance imaging) machines have become available and for the first time clinicians can visualise prostate cancer. Focal Laser Therapy for prostate cancer continues this development. ProFocal-Rx is able to treat the tumour
as clinicians are able to see the tumour with precision. ProFocal-Rx allows more than 30% of prostate cancer patients to have minimal invasive therapy and preserve their prostate gland.

ProFocal-Rx is a patented laser delivery system that is introduced into the prostate gland with a needle cannula. The laser delivery unit is introduced through this cannula into the proven cancerous area and ProFocal-Rx allows for real time interactive treatment ensuring that the cancer is destroyed. The treatment is performed as a quick outpatient procedure with the patient going home the same day. The side effects of the treatment are less than the diagnostic biopsy interventions that are currently used.

ProFocal-Rx allows men with newly diagnosed prostate cancer to be treated without the risk of urinary incontinence whilst also preserving erections, ejaculation and fertility.

Public/Private Company :Private
Stage/Category: Early stage, MedTech
Contact: Dr Celi Varol
Email: celivarol@gmail.com
Phone: 0412 262 624

Due to the high rates of unnecessary caesarean sections performed globally there has been a push to reduce interventions and increase rates of normal vaginal delivery.

Oli™ allows real time observation of uterine activity, movements, exertion, maternal/fetal wellbeing and how they correlate to progression of labour. The device is a non-invasive patch capable of remotely monitoring pregnancy and labour.

This improves on current monitoring methods as it will show:
• a woman’s ability to progress to a normal delivery
• early identification of the need to intervene and the performance of those interventions
• expected time frames for delivery or prompt identification of failure to progress.

Oli™ has the potential to transform obstetric monitoring and management. It provides a way to identify how a woman’s pregnancy and labour is progressing. This will give clinicians and hospital staff a more definitive method of:
• differentiating between slow progression of labour and complications requiring intervention,
• identifying complications early and tracking performance of interventions
• scheduling required resources at the time they are required.

Oli™ is expected to improve patient outcomes and result in savings to the health system due to reduced caesareans and other interventions.

Public/Private Company: Private
Stage/Category: Early stage, MedTech
Website: www.baymatob.com
Contact: Sarah McDonald
Email: sarah.mcdonald@baymatob.com
Phone: 0467 712 886

Hypertension is a strong risk factor for cardiovascular disease, which is the leading cause of death worldwide. 28% of adults in NSW have hypertension, however up to one in eight patients fail to achieve blood pressure control despite multiple medications.

Western Sydney Local Health District has developed the Mu Catheter, a new generation microwave renal artery denervation system for treating hypertension. The device, which is introduced into the renal artery, ablates hyperactive renal nerves that course around the artery. These nerves are responsible for driving high blood pressure in patients who do not respond adequately to medications.

Clinically available renal artery denervation devices heat using electrical current, which has limited depth of penetration and cannot be applied circumferentially as it injures the renal artery wall. As many nerves can potentially escape ablation, these devices produce inconsistent denervation and clinical efficacy.

In contrast, the Mu Catheter radiates microwaves into the tissues surrounding the renal artery. These provide a deep and circumferential ablation to consistently reach more renal nerves while avoiding injury to the renal artery which is cooled and protected by blood flow. This is achieved through the Mu Catheter’s unique microwave
emitting antennae and centering mechanism.

The device is expected to improve patient outcomes and reduce the burden on the health system through better control of hypertension and cardiovascular disease prevention.

Stage/Category: Early stage, MedTech
Contact: David Markwell
Email: David.Markwell@health.nsw.gov.au
Phone: 0439 875 825

Nano-X is an Australian medtech company building novel radiotherapy systems for treating cancer. The Nano- X Latus device enables affordable, precision radiotherapy treatments to be decentralised and accessible in resource limited locations where the large capital and operational costs and high staff-to patient ratios of conventional radiotherapy systems limit their utilisation.

Nano-X leverages real-time radiotherapy at the core of its devices to deliver world leading clinical precision radiotherapy. This technology has been developed in partnership with The University of Sydney and has demonstrated superior cancer targeting accuracy, reduced treatment margins, better tumour dose coverage and lower toxicity.

The Nano-X Latus device is an innovative Australian-designed and developed cancer treatment system changing the delivery of radiation therapy. Its advanced on-board system captures 3D images in real-time and uses that
information to deliver the correct amount of radiation automatically to the cancerous tissue. Nano-X Latus is smarter and smaller than its competitors with smaller capital, operational and staffing overheads.

Nano-X is a portfolio company of ATP Innovations.

Public/Private Company: Private
Website: www.nano-x.com.au
Contact: Dr Ilana Feain, Founder & CEO
Email: ilana.feain@nano-x.com.au
Phone: +61 2 9209 4444
Address: Suite 145, National Innovation Centre, Australian Technology Park, Eveleigh NSW 2031

Respiratory Innovations has developed a device which utilises biofeedback to inform patients how to adjust their breathing. This biofeedback facilitates stable and regular motion of a patient’s anatomy and treatment area. This
increases the accuracy of medical imaging and cancer radiation treatment and also empowers patients to play an active role in improving their own treatment simply by breathing. This device will minimise radiation damage to
the hearts of breast cancer patients leading to better post-cancer treatment outcomes.

Respiratory Innovations’ flagship product: Breathe Well, guides breast cancer patients to perform breath holds so that their heart moves further away from the radiation beam, minimising cardiac complications that otherwise arise when radiation damages the heart. The design of the Breathe Well medical device has been informed by extensive customer engagement through 165 customer interviews representing over 60% of the Australian market.

Respiratory Innovations was recently awarded the NSW Industry Collaborative Solutions grant, fostering partnerships with NSW radiotherapy centres to be the first users of the Breathe Well device. Founder Sean Pollock recently moved from academia into a full time role with the company having completed his PhD in medicine at the University of Sydney, researching the Breathe Well technology. The Breathe Well device is protected by a granted patent, and two provisional patents have also been filed. Breathe Well is also a registered trademark. Respiratory Innovations has an executed IP licensing agreement with the University of Sydney.

The Respiratory Innovations team has taken Breathe Well through the Genesis and Incubate startup accelerator programs at the University of Sydney. Founders Paul Keall and Sean Pollock are 2014 and 2015 graduates of the Medical Device Commercialisation Training Program, respectively.

The immediate future of Respiratory Innovations is the Australian market launch of the Breathe Well product with radiotherapy centres and team expansion. NSW will be the launching pad to then scale across Australia and internationally.

Public/Private Company: Private
Stage/Category: Early stage, medtech-oncology
Website: www.breathewell.co
Contact: Sean Pollock, Chief Operating Officer
Phone: +61 404 759 239
Email: seanpollock@breathewell.com

The Auditory Cortical Discrimination (ACORD) test module, to be implemented in the HEARLab® platform, is a world-first tool that will change clinical management for infants identified with hearing loss through newborn hearing screening programs. ACORD will provide objective evidence at the critical earliest possible age to assist clinicians in making recommendations to parents as to whether their hearing-impaired infants will develop the best language abilities through either use of hearing aids or receiving cochlear implants.

Permanent childhood hearing loss has adverse developmental and health impacts on children’s lives – including speech and language, literacy, mental health, educational achievement, employment and social-economic opportunity in life.

Through its technology engineering projects, HEARworks has already developed three test modules for the HEARLab system, enabling hearing loss to be automatically detected in infants, adults and the elderly, and reducing the number of appointments required for hearing aid fitting. Installed in Australian Hearing Centres across Australia, HEARLab is improving healthcare services for Australians, while saving precious healthcare clinical resources through more efficient services. HEARworks has continued to develop its NSW-based sound processing engineering team, creating new commercial and employment opportunities for NSW graduates.

In 2013, HEARworks was awarded a NSW Medical Devices Fund grant to develop an Automated Cortical Assessment Test module for the HEARLab® platform. This module uses the electrical responses from the brain to automatically assess a patient’s hearing capabilities to produce an audiogram – a graphical measure of a patient’s hearing status.

The ACORD test module will be the game changer - clinicians will be able to identify infants (age 3 months) for whom a hearing aid will not effectively support normal language development. The ACORD test will monitor a baby’s brainwaves when speech sounds change from one sound to another and will automatically determine whether the baby’s brain can tell the sounds apart.

Despite early detection through newborn hearing screening programs and early device fitting, the decision on whether hearing aids are sufficient, or a cochlear implant is required, must often wait until a child has used hearing aids for their first critical years of life. Currently, half of hearing-impaired children present with delayed language skills by 5 years of age. It is currently not possible to identify which children should proceed to cochlear implants before they present with language delays at 3 years of age.

The ACORD module in the HEARLab® system will empower clinicians to (1) evaluate and fine-tune hearing aids so they have proper access to sound and can tell them apart, which both are crucial for language development; and (2) refer infants for cochlear implant candidacy at the earliest possible age (3 months) with confidence. The objective evidence will support counselling for families to make informed decisions about the best strategy for managing hearing loss in their child.

Use of The ACORD module will increase the efficiency of clinical management of infants with hearing loss, enabling precious hearing healthcare resources to be applied more effectively to serve NSW’s growing population. The ACORD module will be developed by HEARworks highly skilled engineering software development team based in NSW at the National Acoustic Laboratories.

Public/Private Company: Private
Stage/Category: Medical and Health Technology Research and Translational Activity
Website: www.hearworks.com.au
Contact: Professor Robert Cowan, Managing Director
Phone: +61 3 9035 5347
Email: rcowan@hearingcrc.org

Elastagen is a highly innovative NSW medical device company and a world leader in the development and application of products based on its unique tropoelastin-based biomaterial platform. Tropoelastin is the building block of elastin, a critical component of tissues such as skin, arteries and the lungs, providing physical properties of elasticity, resilience and recoil. Elastin and its precursor, tropoelastin, also play a significant role in the tissue repair process following injury or disease, attracting and guiding the growth of cells involved in tissue repair. This technology was founded on the work of Prof Tony Weiss at the University of Sydney who is a world leader in this field. This tropoelastin platform and products are underpinned by a strong portfolio of granted and pending patents in the major global markets as well as significant proprietary know-how.

Elastagen’s medical devices are focused on atrophic scars (including stretch marks and acne scars), aesthetics and skin regeneration. The Company’s injectable products for the treatment of stretch marks, acne scars and the rejuvenation of aging skin are all progressing through clinical development. Elastagen also has an advanced preclinical product for skin regeneration and wound repair that is ready to enter the clinic.

As a result of a previous NSW Medical Devices Fund award in 2013, Elastagen was able to establish proof of concept for a skin regeneration product that enabled the Company to attract additional funds from the Wellcome Trust. This was followed by an international Series B equity raise and securing a major development and commercialisation partnership with a leading international player in the wound repair space. Elastagen have previously shown that by incorporating the proprietary tropoelastin protein into dermal regeneration, the key biological and structural cues prime the device with improved vascularisation, dermal regeneration and re-epithelialisation – critical for the
regeneration of healthy skin and healing of chronic wounds. As such it is expected that this technology will create a second generation of the market leading products of Elastagen’s partner and improve medical outcomes for patients suffering from severe burn scar contractures and chronic wounds.

The 2016 Medical Devices Fund award will provide the funding for the commercial-scale manufacture of our proprietary tropoelastin protein and support the Company’s ongoing evolution. The corporate partnership in wound repair and the Medical Devices Fund award represent a transformative milestone in establishing Elastagen as a commercially successful NSW device company.

Public/Private Company: Private
Stage/Category: Clinical Stage/Medical Device
Website: www.elastagen.com
Contact: Robert Daniels, CEO
Email: rob@elastagen.com

PAFtec Australia specialises in innovative and quality respiratory protection device design and manufacturing.

Founded by a world class medical device engineering team with a vision to make respiratory protection wearable and easy to use. The team has previously designed medical products from concept to manufacturing that are currently being used by millions of people around the world. Their expertise is the reason our products (CleanSpace™ Respirators) are safe, robust and high performing even in the harshest environments. These award winning respirators are used by companies all around the world from mine sites in the Pilbara to manufacturers and specialists in transportation, infrastructure and energy. Sold in over 20 countries around the world, CleanSpace™ deliver significant safety and compliance benefits over traditional masks.

CleanSpace™ Respirators are the world’s smallest and lightest powered respirators and a game changer for respiratory protection. CleanSpace™ Respirators are certified to the high P3 protection (99.98% filtration efficiency for particles 0.3 micron and above) have patented, breath-responsive algorithm and a powerful, efficient micro-turbine motor which permits the airflow to be adjusted in situ to match the wearer’s breathing. The powered airflow offers both protection and comfort for long periods (up to 8 hours) – ideal for primary healthcare, screening, triage or treatment by first response in the field operations where traditional powered masks fail.

Every CleanSpace™ respirator is individually tested for quality and performance in our facility in NSW, Australia. The Company’s Quality Management System is accredited to the globally recognised ISO 9001 standard. An important element of using a CleanSpace respirator is our training. PAFtec was one of the first respirator manufacturers to develop an online training system with compliance tool enabling rapid high volume deployment in remote
locations. The Training Program has been developed with our customers’ in mind and is augmented by our product specialists and distribution partners.

There is an opportunity to extend the patented CleanSpace Technology to develop a respirator to meet the specific needs of healthcare workers. The device will be tested and used for protection of healthcare workers at high risk of airborne infectious disease (ie Ebola, Viral Haemorrhagic Fever, Tuberculosis). In conjunction with world class researchers in NSW in the areas of respiratory protection and infectious disease, PAFtec plans to clinically evaluate the performance and staff acceptance of the CleanSpace PAPR with full face mask in hospital and remote field operations.

Public/Private Company: Private
Stage/Category: Pre-clinical Respiratory Protection device with Revenues in adjacent applications
Website: www.cleanspacetechnology.com
Contact: Dr Alex Birrell, Chief Executive Office
Email: alex.birrell@paftec.com
Phone: +61 2 8436 4000

Thru-Fuze Orthopaedics Pty Ltd is an early stage NSW Biotech company formed to bring this development from UNSW Australia to benefit the people of NSW, Australia and the world.

Thru Fuze has received seed funding (AUD$2.3 million + IP costs) from Intellectual Ventures, this has provided Professor Walsh and UNSW Australia assistance in the research and development phase of this project and in protecting the related intellectual property.

Thru Fuze will use the support provided by the NSW Medical Devices Fund to more forward with clinical trials.

The Thru-Fuze™ device is a new orthopaedic device for the treatment of spinal disorders. The device is positioned between the transverse processes of adjacent vertebrae and facilitates rapid fusion of bone both on and through the device.

The Thru-Fuze™ device was conceived and invented at UNSW Australia by Professor Bill Walsh and Dr Matt Pelletier. Initial funding provided by Intellectual Ventures ($2.3 million) allowed a team of global industrial experts (Dr Andy Carter and Orchid Design (USA)) to assist in product development. The NSW Medical Devices Fund grant will allow this work to be taken into the clinical arena and assist this Australian innovation to realise its global healthcare potential.

The Thru-Fuze™ device helps alleviate chronic back pain, such as that caused by degenerative disc disease. During spinal fusion surgery, the device is fixed between transverse processes of adjacent vertebrae to hold them in place and thus stabilise the spine and alleviate pain. The geometry of the device encourages bone growth through the device providing rapid biomechanical fixation. Over time, the device then acts as a bridge between the adjacent vertebrae for additional bone to grow across thus fusing the adjacent vertebrae together, bone to bone.

Comparable devices include pedicle screw and rod systems with bone graft material. These systems are costly and difficult and time consuming to implant. They also have relatively low rates of fusion success. The Thru-Fuze™ device is simpler, cheaper, and allows faster surgery with less, or no, radiation exposure, and a faster biomechanical fusion.

Public/Private Company: Private
Stage/Category: Early stage biotech
Website: powcs.med.unsw.edu.au/research/groups/surgical-and-orthopaedicresearch-laboratory
Contact: Professor W.R. Walsh, Surgical & Orthopaedic Research Laboratories, Prince of Wales Clinical School, Prince of Wales Hospital, Randwick NSW 2013
Email: w.walsh@unsw.edu.au

Maverick Biomaterials (MBM) has established itself as a key provider of product & service into the emerging transcatheter device arena.

Strong skillsets and IP around materials selection, production and global Quality & Regulatory needs surrounding the use of animal derived biological (ADB) materials in medical products, has MBM working alongside numerous global partners optimising their business and product outcomes.

Over the next 2 years 3-4 of MBM clients will likely attain regulatory approvals for their product and commence market launch, 2 of these in developed markets and 2 in emerging economies. Behind these organisations is the next wave of development targeting mitral valve disease with world 1st products expecting to be on market in 2020.

MBM has been in long term collaboration with these entities, often since their benchtop R&D began, and have co-developed optimum material for product success, and eloquent pathways for Quality & Regulatory approvals being obtained.

MBM utilises its extensive IP developed in the ADB sector to meet the needs of global product developers. The market for aortic valve focussed products is about to experience a wave of new product approvals, and mitral focussed products will launch 2020-2025. The tricuspid arena is now the focus of very early stage R&D.

MBM has developed innovative bovine materials used in the manufacture of heart valves implanted via keyhole surgery techniques. This reduces the patient’s time in intensive care facilities (therefore reducing hospital costs) and allows for valve implantation into frail patients. The Maverick material supports client needs for optimising catheter loading and device performance.

MBM is investing in cleanroom facilities that will be operational Q3 2016 and given growth forecasts will be working diligently to strengthen and enhance the manufacturing process and overarching organisational capabilities.

Over the next 10 years significant growth will occur and MBM will be on the front foot in having the requisite facilities and human resources available to quickly respond to the need of the global market and our dynamic, innovative and entrepreneurial clientele.

Public/Private Company: Private
Stage/Category: Commercialisation / Medical Device / Cardiovasculars
Website: www.maverickbio.com
Contact: Cameron Crowley, Business Development Manager
Phone: +61 2 6885 1200

cmee4 productions is a content creation company focused on harnessing the power of mobile games to help address global health issues.

With over twenty-five years experience in medical and corporate content production cmee4 Productions Founder, Carolyn Mee, has applied her knowledge of creative engagement to the increasingly powerful medium of games with the belief that games can deliver and capture vital health information.

The company’s flagship project, Sound Scouts, offers a revolutionary solution to screen children’s hearing. Developed in collaboration with the National Acoustic Laboratories, led by Dr Harvey Dillon, Sound Scouts looks and feels like a game however it incorporates advanced scientific principles that enable it to detect and identify a range of hearing issues.

Statistics from Australian Hearing show that the second, third and fourth most common ages for children to be fitted with hearing aids are six, seven and eight years of age. Their hearing issues are being detected when they experience learning and social difficulties at school. The need to identify these children before or during their first year of school, to ensure they are not disadvantaged by two, three or more years of not coping, has been a
major driver throughout the project’s development phase.

Sound Scouts’ release meets the need in the hearing healthcare system for a low-cost, easily administered, reliable test of hearing that can be widely accessed. The game is played on a mobile tablet utilising headphones. Parents/caregivers input some details including their child’s age, as results are age dependent, and oversee their children playing, but otherwise the game is completely self-contained.

The game comprises three interleaved tests of hearing; two based on perceiving speech (one in noise and one in quiet), and one based on perceiving tones against a noise background. Each of these constantly adapts so that the child is always listening at the edge of his or her hearing capability. Algorithms within the game check that the child is responding reliably, as well as measuring the child’s actual ability. The results from the three tests are combined to automatically display a test result as soon as the game is completed.

Sound Scouts was recently presented at the International Collegium for Rehabilitative Audiology in San Francisco attracting international development partners.

The Medical Devices Fund grant will help Sound Scouts hearing screening solution to become a routine part of every Australian child’s preschool or kindergarten health check.

Public/Private Company: Private
Stage/Category: Commercialisation Stage and Continued Development
Website: www.soundscouts.com.au
Contact: Carolyn Mee, Founder
Email: carolyn@cmee4.com.au
Phone: +61 414 400 114

Allegra Orthopaedics (“Allegra”) is commercialising a synthetic “load bearing” bone graft medical device, which in one product, presents highly sought after physical, mechanical and biocompatible properties which are
currently not being met in the orthopaedics.

The medical device is a bio-ceramic scaffold with outstanding potential for supporting bone regeneration in load bearing applications. Preliminary studies indicate that it duplicates the mechanical strength, elasticity and bioactivity of bone grafts without the many recognised disadvantages of these current surgical practices; be they autograft (using patient’s own bone), allograft (same species’ bone), xenograft (different species’ bone) or metal implants.

The emergence of synthetic bone substitute materials, with and without biological bone growth factors has been increasing in orthopaedic surgery, however their use has been restricted to fillers or for use in non-load bearing applications.

Allegra’s synthetic bone substitute, Sr-HT-Gahnite has the potential to be the first commercialised synthetic bone substitute platform of products suitable for building bone in large bone defects under load.

Allegra’s technology has been developed by Professor Hala Zreiqat and her team from the Tissue Engineering and Biomaterials Unit, Faculty of Engineering and Information Technologies, University of Sydney. Allegra has licensed the exclusive rights from the University of Sydney to the late stage patent applications which cover the formulation, production techniques and application of this breakthrough material.

Sr-HT-Gahnite presents a major advance in synthetic materials by combining a highly porous and interconnected scaffold with outstanding mechanical and bioactive properties for regenerating large bone defects under load. There is no perceived restriction for the product as it has the potential for use in non-load bearing as well as load bearing applications in all ages.

There are no synthetic alternatives to Sr-HTGahnite as all options are indicated for non-structurally integral uses. The current practice to address load bearing implants is through either metal only, with slow to no bone integration, or through autogenic and allogeneic implants with their inherent disadvantages.

Bone graft products are used in a wide range of orthopaedic surgery applications; fusing joints to prevent movement in the spine and/or extremities; repair injured bone/joints; accelerating repair of fractures with bone loss, or simply repair bone voids from surgery, trauma, removal of bone tumour, disease and/or infection.

The clinical relevance of Sr HT-Gahnite’s potential include reduced morbidity associated with a second surgical procedure, reduced infection risk, reduced medication and based on the pre-clinical evidence to date, there is the potential for more rapid bone growth leading to improved patient recovery rates.

Allegra is a publicly listed company on the ASX and its sales, design and manufacturing team is based in St Leonards at its 2,000m2 manufacturing facility.

Public/Private Company: Public ASX: AMT
Stage/Category: Pre-clinical medical devices with orthopaedic revenues
Website: www.allegraorthopaedics.com
Contact :Tom Milicevic, Chief Executive Officer
Email: tom.milicevic@allegraorthopaedics.com
Phone: +61 402 304 015

Kico Knee Innovation Company provides orthopaedic surgeons with state of the art dynamic, functional and patient specific planning and simulation solutions. The technology is currently focused for application on total hip
and knee arthroplasty.

Using engineering techniques derived from aerospace and automotive industries, our software provides dynamic information about an individual’s joint performance in more depth than ever before.

Over 2,000 patients have already been analysed. In August a new milestone was achieved with 100 cases being simulated prior to surgery. Substantial clinical interest has developed around the world. In Australia, significant commercial progress has been made with our hip partner Corin and our knee partner Global Orthopaedic technology.

Public/Private Company: Private
Stage/Category: Early stage commercialisation
Website: www.optimizedortho.com
Contact: Bede O’Connor

The Kids Research Institute is a leading translation research centre for children, embedded in the Sydney Children’s Hospitals Network (SCHN) and located at The Children’s Hospital at Westmead. Our translational research provides patients and families early access to new and innovative treatments and improves the quality and efficiency of our clinical services.

The Orthopaedic Research and Biotechnology Unit, led by Professor David Little at the SCHN is focussed on advancing orthopaedic care through an improved understanding of bone diseases, advancing bone healing and development of orthopaedic implants. A pipeline of novel implantable devices is currently being developed.

The SCHN is commercialising a revolutionary paediatric implant (SyMaxys) to treat children born with brittle bones or malformed legs. The technology, which was developed by Professor David Little and Dr Justin Bobin, addresses an unmet clinical need for fixation devices which grow with the child’s bone. The SyMaxys technology provides constant stability and support to the limb necessary for correcting the disorder, while accommodating bone growth. The novel design extends the life of the device and minimises the need for invasive replacement surgery.

The underlying technology is subject to patent applications, and will be applied to other conditions such as spinal disorders where both stability and movement are equally important.

The SCHN is currently negotiating a licence agreement with a leading orthopaedics device company to complete the development and commercialisation of the device. Professor Little and his team will complete the development and testing of the SyMaxys device in NSW before seeking regulatory approval to start applying it in patients. They anticipate having the device available within three years, with the SCHN being the first to offer this device to its hospitals – Sydney Children’s Hospital, Randwick and The Children’s Hospital at Westmead.

Website: www.schn.health.nsw.gov.au/www.kidsresearch.org.au/
Contact: Professor David Little, Paediatric Orthopaedic Surgeon, The Children’s Hospital at Westmead, Head of Orthopaedic Research and Biotechnology Unit, SCHN Professor of Paediatrics & Child Health

SpeeDx is a medical diagnostic company focused on developing and commercialising clinical tests based on their patented, ground breaking DNA analytical technologies. Their innovative chemistries have a superior capacity to detect multiple clinically relevant genetic biomarkers in patient specimens. This provides a platform for developing a wide range of diagnostic tests based on detecting the genetic “bar-code” of disease-causing bacterium or viruses, or of human genes associated with cancers and other diseases.

SpeeDx has created a successful business based on licensing its inventions which are protected by an extensive patent portfolio. Their licensees market and develop products for clinical research and human diagnostics. For example, Bioline Australia has been licensed to sell kits to hospitals and private pathology laboratories for assessing efficiency of genetic testing procedures. These kits are widely used within Australia and are now being
launched internationally. Another licensee, Biocartis NV a European reagent and instrument manufacturer, anticipates launching a “companion diagnostic” using SpeeDx’ technology in early 2015. This product will allow oncologists to tailor therapy for patients by measuring features of their cancer. This information allows the prescription of the drug(s) most likely to be effective in treating the cancer. The product analyses more cancer
mutations in a single reaction than competitors’ kits, and is more sensitive.

Capital generated from SpeeDx’ early licencing and co-development activities has funded internal development of a pipeline of diagnostic products, in line with the company’s longer term goals. The most advanced is a test to detect eight bacteria and viruses known to cause meningitis in children and adults. This will provide a tool to identify the pathogen and aid rapid diagnosis of this potentially life threatening disease. Other products are in earlier stage development. SpeeDx’ initial tests will run on instruments already in routine use in pathology laboratories so that adoption will not require investment in new equipment or additional staff training.

The company is also working on next generation “point of care” solutions, aimed at moving testing out of laboratories and to the patients’ location. The team sees this as an area where significant value can be added, particularly in critical care and/or rural settings where access to equipment may be limited.

SpeeDx has a strong track record of developing and commercialising novel technology applicable to medical diagnostics. Inspiration for invention comes from staff at all levels of this innovative, dedicated team including graduate students enrolled through the University of NSW. The company strives to make an impact on human health both locally and globally.

Public/Private Company: Private
Stage/Category: Clinical Development Stage, Molecular Diagnostics
Website: www.speedx.com.au
Contact: Alison Todd, General Manager and Chief Scientific Officer
Email: info@speedx.com.au

Elastagen is a clinical stage medical device company that is pioneering elastatherapy™ using the human protein elastin to naturally repair the skin.

Elastin is a critical component of the skin, being present as fibres which confer unique physical properties to skin tissue. Elastin enables the skin to endure constant stress, especially in areas requiring repeated stretch and recoil such as at the joints. Elastin also plays a critical role during the wound healing process where it contributes to reduced wound contraction and improved skin tissue regeneration.

Elastagen’s technology has been developed over the past twenty years by Professor Anthony Weiss and his Elastin Laboratory at the University of Sydney. Elastagen has acquired exclusive rights from the University of Sydney to a broad patent portfolio which covers the production, formulation and application of this unique biomaterial.

Elastagen is the first company globally to have succeeded in the scalable, commercial, clinical grade manufacture of the full length recombinant human elastin protein. In addition, the company has completed a broad range of pre-clinical and clinical studies and successfully demonstrated the potential of its elastin biomaterials to assist in skin repair and regeneration.

A major focus for the elastin technology is on the medical repair and regeneration of the skin. For example, following recovery from burn injuries, patients will often have severe scarring which requires surgical revision due to discomfort and a lack of skin mobility. The surgical revision involves the removal of the scar tissue and replacement with a skin template to encourage the growth of a more natural skin.

Elastagen has worked closely with Prof Weiss at the University of Sydney and leading burns surgeons to demonstrate that elastin has the potential to improve the performance of the skin template.

The inclusion of elastin may enable both a reduction in the required number of surgical interventions and result in a significant improvement in the quality and physical properties of the repaired skin. The company is now planning to undertake further clinical studies of this promising technology prior
to seeking regulatory approval of the product.

Elastagen is located in Sydney, Australia, and is a venture backed private company.

Listed/Private Company: Private
Stage/Category: Clinical Stage/Medical Device
Website: www.elastagen.com
Contact: Robert Daniels, Chief Executive Officer
Email: r.daniels@elastagen.com
Phone: +61 424 439 481

Endoluminal Sciences is developing a breakthrough technology for the treatment of failing heart valves.

While minimally invasive techniques to insert heart valves are a significant improvement over open heart surgery, there is a major limitation with the therapy.

Critical leakage from around these valves inserted by the less invasive catheter technique occurs in up to 50 per cent of patients. As a result of this complication, some of the blood pumped into the aorta leaks back into the heart, weakening it and eventually leading to heart failure.

Endoluminal Sciences’ solution is a novel sealant-based medical device that uses a combination of
state-of-the-art mechanical engineering and polymer science to overcome the life-threatening failure mode of leakage from around the sides of minimally invasive heart valve implants. The technology addresses the problem of leakage in a manner superior to any device currently in clinical trials or on the market anywhere in the world.

The innovation is geared towards dramatically improving medical outcomes and safety for patients while at the same time significantly improving ease-of-use for the physician and reducing the financial cost to the health system.

The technology has received several accolades internationally including being recognised as the top five new technologies in structural heart disease at the world’s largest conference in Interventional Cardiology Medicine, Transcatheter Cardiovascular Therapeutics.

The leadership team of Endoluminal Sciences constitutes a pioneering profile in global medical device technology development and commercialisation. Endoluminal Sciences is further supported by a global network of clinical practitioners and researchers considered key opinion leaders in the fields of interventional cardiology, cardiovascular and vascular surgery.

Currently, the problem of leakage limits the extension of benefits of minimally invasive heart valve replacement to patients that are currently offered open heart surgery. Endoluminal Sciences’ technology has the potential to enable practically all patients with failing heart valves to be treated
by a minimally invasive technique – making open heart valve surgery a thing of the past.

Endoluminal Sciences’ immediate focus is the minimally invasive treatment of aortic valve stenosis (disease causing narrowing of the aortic valve) and mitral valve regurgitation (disease causing leakage of the mitral valve) – common conditions that together constitute the vast majority of serious heart valve disease affecting the population. The intellectual property portfolio developed by Endoluminal Sciences also has direct applicability for treatment of a much broader range of vascular and structural heart disease states, including the treatment of pulmonic and tricuspid valve disease, and the treatment of abdominal and thoracic aortic aneurysms.

Listed/Private Company: Private
Stage/Category: Early Stage/Medical Device Technology/Cardiovascular
Website www.endoluminalsciences.com
Contact: Ashish Mitra, Chief Executive Officer
Email: amitra@endoluminalsciences.com
Phone: +61 421 509 033

HEARworks Pty Limited is the commercial arm of the The HEARing CRC and works in concert with that
organisation for the common purpose of creating sound value™ through research and innovation to prevent, and to better remediate, lost productivity resulting from hearing loss in children and adults.

HEARLab is an innovation of the HEARing CRC and National Acoustics Laboratories, developed to meet the needs of clinicians for a portable, multifunctional instrument to conduct electrophysiology for the assessment of hearing. HEARLab comprises basic hardware that is driven by software modules running on a standard laptop computer.

The first two HEARLab modules are for Aided Cortical Assessment and Auditory Brainstem Response testing respectively. These modules were developed with funding support from the Commonwealth, AusIndustry and the NSW Government.

The Medical Devices Fund grant will help to fund the development of the third HEARLab module –
the Automated Cortical Assessment test.

This critical new piece of software will provide the world’s first fully automated and totally objective
test of hearing thresholds.

The test will safely and painlessly measure signals generated by the auditory cortex of the brain in response to sound, while not requiring any active automated, which will both decrease the time needed to perform the test, and also decrease the skill level needed to administer the test.

There is a need for this test at both ends of life.

Firstly, it will enable the testing of awake babies and older children with multiple disabilities, even
those with auditory neuropathy (a form of deafness that cannot currently be objectively assessed in any other way).

Secondly, it will enable the testing of elderly people who cannot respond behaviourally, typically because of stroke or dementia. The new test will therefore fill a gap in the tests available to clinicians who work with babies and elderly people with cognitive impairment. It will also have application in testing hearing to verify hearing loss in those seeking compensation for occupational noise injury.

HEARLab and the Automated Cortical Assessment test will be welcomed around the world, but the inclusion of Australian Hearing within the Hearing CRC will ensure that it is immediately available to
the people of NSW. In addition, the initial trials with the new module will occur here, at the Australian Hearing Hub in Sydney.

Listed/Private Company: Private
Stage/Category: Growth Stage/Biotechnology Commercialisation
Website: www.hearworks.com.au
Contact: A/Prof Robert Cowan
Email: rcowan@hearingcrc.org
Phone: (03) 9035 5347

MobiLIFE is a joint venture company established by medical device executives and the University of Newcastle (UoN) to deliver ideas and concepts into the medical device marketplace. Since its inception in 2002 the company has grown in strength with an exceptional team of individuals with a background of delivering results in the medical device sector.

MobiLIFE is nearing the commercialisation stage of its first project, which is aimed at significantly improving the choice and quality of treatment options available to medical professionals for the care of patients outside of hospital i.e. home care based treatments.

The mobiLIFE home care project is based on the mobiDRIP; an innovative new portable intravenous (IV) pump developed by researchers at UoN. The history of the project is that a conversation over
coffee resulted in a radically new conceptual design being sketched on a napkin!

The mobiDRIP is a unique, new, low cost, high accuracy, mechanical infusion device; the first hybrid device to combine the accuracy of an electronic pump with the low price tag of a disposable pump.

This new infusion pump, which is revolutionary in its simplicity, reduces costs and improves patient
care.

The mobiDRIP has been ergonomically optimised and can be worn discreetly by a mobile patient whilst aiding recovery by intravenously delivering continual dosages of medical fluids such as antibiotics, pain relief, chemotherapy and nutrition.

The device provides greater choice for nursing staff and facilitates more rapid hospital patient discharge; resulting in considerable cost savings for the health care system and better outcomes
for patients.

The future outlook for mobiLIFE is very exciting. The company has already established a Therapeutic Goods Administration approved clean room and rapid response drug compounding service that utilises the latest facility design to provide the high service levels demanded by the market. This new Good Manufacturing Practice licence approved facility provides for the filling and delivery of mobiDRIPs to NSW, QLD and beyond.

MobiLife’s next focus is to utilise the product refinement, reference sites and revenue stream created by the successful domestic commercialisation of the mobiDRIP device and service, to support the insertion of the mobiDRIP device into the globally significant home care markets.

Listed/Private Company: Private
Stage/Category: Early Stage/Medical Device & Pharmaceutical Services
Website: www.mobilifemedical.com
Contact: Prof Paul Dastoor, Director
Email: Paul.Dastoor@newcastle.edu.au
Phone: (02) 4921 5426

Saluda Medical is a Sydney based start-up company developing a groundbreaking new implantable device for the treatment of chronic neuropathic pain. The company was spun out of National ICT Australia, Australia’s leading ICT research establishment in early 2013 to commercialise a range of
neurostimulation technology developed there over 4 years.

Using a world’s first neural recording technology, the company will initially focus on developing a
closed-loop feedback spinal cord stimulation device.

The neural recording technology makes it possible to measure the minute electrical responses from
nerves immediately after they have been stimulated. Existing devices cannot make this measurement and so rely on manual intervention to establish an optimal level and location. Once commercialised,
experts believe this technology will make its way into every neuromodulation device implanted in a
human, be it for spinal cord stimulation, deep brain stimulation or other treatments comprising a global market worth $3 billion per annum.

Spinal Cord Stimulation is a treatment for chronic neuropathic pain where the electrical stimulation
replaces the pain with a buzzing or tingling feeling in the area of the pain. Current products suffer the
major problem that as the patient changes posture, the spinal cord moves relative to the electrode
causing the level of stimulation of the nerves to change. This variability causes many patients severe
discomfort leading some to elect not to have a permanent implant while others set stimulation levels below the optimum. It also results in patients needing to continuously manually adjust the level of
stimulation. Closed-loop feedback control of stimulation allows for the automatic setting of an
optimal level of stimulation.

The company has already trialled its technology on human subjects in acute settings using a prototype
externalised stimulator. Results so far indicate that a device using closed-loop feedback controlled
stimulation provides improved pain relief, more of the time, without unpleasant side effects or the
need for continuous manual readjustment by the patient.

These results have been presented at key US and European scientific conferences in the field to the
acclaim of leading neuromodulation surgeons and academics.

Saluda Medical is now in the process of engineering an implantable device and conducting clinical trials to support regulatory approval of the device to commence sales in 2016.

Listed/Private Company: Private
Stage/Category: Commercialisation Stage, Neuromodulation
Website: www.saludamedical.com
Contact: Dr John Parker
Email: john.parker@saludamedical.com
Phone: (02) 9376 2125

The purpose of this study is to examine how older people with cancer and their families living in rural communities are affected by the burden of treatment. The objective is to identify how to enhance their capacity to manage this treatment through appropriate use of resources, including their local networks.

PhD Supervisor: Professor Vicki Parker
Health Practitioner/ Policy Supervisor: Roslyn Everingham, Hunter New England Local Health District
Priority Area: Health systems research

This PhD aims to identify the most clinically useful method for measuring the QT interval on a patient’s ECG which will ensure that an appropriate tool is used to assess QT prolongation in patients using psychiatric medication.

PhD Supervisor: Professor Jennifer Martin
Health Practitioner/ Policy Supervisor: Roslyn Everingham, Hunter New England Local Health District
Priority Area: Epidemiology & Implementation science

The aim of the PhD research project will be to identify biomarkers of Anxious Depression, with a specific focus on biomarkers related to treatment prediction.Identifying biomarkers of Anxious Depression has the potential to enhance our understanding of its biological underpinnings, resulting in more accurate predictions of risk, prognosis, and treatment response.

PhD Supervisor: Associate Professor Anthony Harris and Dr Donna Palmer
Priority Area: Implementation science

This research will utilise a new and sophisticated health records data linkage platform, the Illawarra Health Information Platform, to investigate patterns of dementia identification during hospital admissions over a 10-year period, and to establish any relationships between dementia identification and patient outcomes. This will be accomplished through retrospective, longitudinal analysis of admissions for people with dementia and a matched cohort. Emergency department and inpatient data sets from the Illawarra Shoalhaven Local Health District, linked with mortality data, will be utilised.

PhD Supervisor: Dr Lyn Phillipson, Dr Luise Lago and Professor Kathy Eagar
Health Practitioner/ Policy Supervisor: Dr Jan Potter
Priority Area: Epidemiology

This project seeks to understand parent’s immunisation experiences with the NSW and Australian health systems.This project will identify the key areas in the NSW and Australian health systems that can be improved. Recommendations will be made that are based on the results of feedback from clinicians, policy makers and immunisation advocates, with the aim of preventing children from acquiring the flu and whooping cough.

PhD Supervisor: Associate Professor Kristine Macartney and Associate Professor Julie Leask
Priority Area: Health systems research

This study is based on the findings of completed research about HPV vaccination in 40 Australian secondary schools (HPV.edu) funded by the National Health and Medical Research Council. This study will work collaboratively with key stakeholders to implement evidence-based research findings into policy and practice within relevant health and education settings, and measure the effectiveness of these changes. Key outcomes include enhancing the communication of research findings and identifying best practices for implementation.

PhD Supervisor: Professor Rachel Skinner and Associate Professor Melissa Kang
Health Practitioner/ Policy Supervisor: Associate Professor Kristine Macartney
Priority Area: Implementation science

The aim of this research project is to develop an effective tool and method to gather patient feedback to train future doctors to be more ‘patient-centered’. To develop the tool, several groups of people will be consulted including patients, doctors in training, and doctors who are supervisors. The tool will then be tested with junior doctors and actors in a simulated environment. Following this, the tool will be piloted and tested in a hospital.

PhD Supervisor: Professor Wendy Hu
Health Practitioner/ Policy Supervisor: Professor Kevin Pile
Priority Area: Implementation science

This study aims to establish a clear understanding of the progression of behavioural symptoms in patients with Motor Neurone Disease, Corticobasal Degeneration & Progressive Supranuclear Palsy. These groups will be compared to a cohort of patients with behavioural variant Frontotemporal Dementia where behavioural changes are well established.The project will examine how these behaviours match with structural changes in the brain, using neuroimaging techniques like magnetic resonance imaging (MRI). This will help identify similarities and differences between the neurodegenerative diseases, allowing researchers to better distinguish between them.

PhD Supervisor: Professor Matthew Kiernan
Priority Area: Epidemiology

Lung cancer is one of the most common and lethal malignancies globally. About 3-7 per cent of patients with non-small cell lung cancer have a rearrangement in a gene called EML4-ALK (the ALK gene).New drugs that target this genetic alteration in ALK have been developed that can be effective in shrinking these tumours such as crizotinib. However, resistance to crizotinib treatment in these patients is inevitable and the cancer will begin to spread again. Recently, it has been shown that treating patients with a new anti-ALK drug, for example lorlatinib, may make the resistant tumours sensitive to treatment again.The research project will focus on why interchanging these drugs in a fixed alternating schedule may overcome drug resistance in these ALK patients.

PhD Supervisor: Associate Professor Nick Pavlakis, Professor Stephen Clarke, Dr Viive Howell, Dr Sarah Hayes and Dr Chee Lee
Priority Area: Implementation science

The study aims to measure the impact of the addition of a comprehensive evidence-based intervention to routine prenatal care in women referred to substance use in pregnancy services.

PhD Supervisor: Professor Amanda Baker
Health Practitioner/ Policy Supervisor: Conjoint Professor Adrian Dunlop
Priority Area: Health systems research

The project will develop a cohesive strategy to enable people living with cancer, their carers and health providers to use proven methods to better manage cancer nerve pain. Cancer nerve pain stops people from participating in society by causing worse physical, cognitive and social function.The project will use a national database with over 100,000 encounters to target interventions where greatest impact is expected.

Supervisor: Professor Meera Agar, Professor Jane Phillips and Professor Melanie Lovell
Health Practitioner/ Policy Supervisor: Professor Martin Stockler
Priority Area: Implementation science

Frailty in heart failure patients is linked to a significantly higher rate of hospitalisation and death. If heart failure patients who are frail can be identified earlier, solutions can be put in place to try and improve their frailty.The project will compare four different measurement tools used to assess frailty in the form of a clinical study currently taking place at St Vincent’s Hospital Sydney. The aim is to find out which is the most accurate and reliable tool for use in patients with heart failure.

PhD Supervisor: Professor Phillip Newton
Health Practitioner/ Policy Supervisor: Professor Peter Macdonald
Priority Area: Implementation science

Large studies to understand the cellular and genetic characteristics of mucinous cancers are needed to help guide diagnosis and treatment for these patients.The project will analyse large datasets of histological and molecular information to better characterise these cancers. The key aims are to find markers that improve diagnosis and uncover treatment targets.

PhD Supervisor: Professor Susan Ramus
Health Practitioner/Policy Supervisor: Professor Michael Friedlander
Priority Area: Molecular epidemiology

Preventing low blood pressure during shock is an integral part of treatment, but it is unclear what level of blood pressure is most effective for an individual patient.The aim of the research program is to compare standard care to implementation of a strategy, where patients’ pre-illness resting blood pressure is targeted during the management of shock in the intensive care unit.

PhD Supervisor: Professor John Attia
Health Practitioner/ Policy Supervisor: Professor Anthony Quail
Priority Area: Implementation science

A new taxon of a Gram negative bacterium, referred to here as GM1, has recently been discovered. GM1 appears to secrete an antibiotic-like compound, as yet uncharacterised.The PhD project will complete the genome sequence; characterisation; determine the chemical structure; and investigate the clinical usefulness of the antibiotic secreted by GM1.

PhD Supervisor: Dr Peter Anderson
Priority Area: Genomics

The focus of this research strategy is rare childhood cancers and their management.Our approach aims to increase the understanding of the biological factors that are both common to the disease types, but unique to individual patients.What is gained from the analyses of these disease paradigms is a better understanding for the treatment of cancer in the population as a whole. By increasing the understanding of the incidence of complex disease in our kids a better understanding will be gained of how to address the management of cancer in adults.

PhD Supervisor: Associate Professor Paul Kennedy
Health Practitioner/Policy Supervisor: Associate Professor Daniel Catchpoole
Priority Area: Bioinformatics

The purpose of the PhD is to test whether linking patients to existing clinical and healthy lifestyle services improves clinical outcomes and overall health risk, and reduces waitlists for specialist consultation. The PhD will specifically involve conducting a randomised controlled trial targeting healthy lifestyle behaviours in overweight and obese patients with low back pain, a systematic review of the literature, and thesis by publication.

PhD Supervisor: Dr Christopher Williams
Health Practitioner/ Policy Supervisor: Professor John Wiggers
Priority Area: Health Systems Research

This project will provide a comprehensive description of how NSW cancer biobanks are supported, what they produce, and resulting cost-benefit and cost-consequence analyses. The project will examine gaps in productivity reporting, and identify how cancer biobanks could better support researchers by considering the under-investigated perspective of biobank users.

PhD Supervisor: Professor Jennifer Byrne
Priority Area: Health economics

Doctors often care for dying patients who are cognitively impaired, and cannot make their own decisions. This can result in competing pressures on individual doctors.A national online survey of doctors will assess this problem from doctors’ own perspectives. A longitudinal study will follow up a group of doctors from early in their careers, exploring their experiences with in-depth interviews. The same doctors will be reinterviewed 2 - 3 years later, to see how they have adapted and coped, what support they have wanted or used, and what they have learnt.

PhD Supervisor: Prof Meera Agar
Health Practitioner/ Policy Supervisor: Prof Elizabeth Lobb
Priority Area: Health workforce

Geriatric hip fracture is a serious injury with high morbidity and mortality. Despite global efforts in reducing mortality with shared geriatric care models and expedited operative intervention, mortality is still high. The project is conducting ongoing epidemiological studies looking at management errors, cardioprotection, timing of surgery with anticoagulants and inpatient morbidity leading to mortality.

PhD Supervisor: Professor Zsolt Balogh Professor John Attia
Priority Area: Epidemiology

Sepsis is life-threatening organ dysfunction due to infection. The project is part of the largest ever study to determine whether giving steroids helps to reduce the mortality from septic shock. Alongside this study a cost effective analysis will be conducted to determine long-term costs and consequences of using steroids to treat patients with septic shock. This will enable an assessment of this treatment in terms of value for money. To do this, quality of life will be measured, the amount of time patients spend in intensive care and hospital, and how much each episode costs within the public hospital system up to 2-years after the episode.

PhD Supervisor: Professor Simon Finfer
Health Practitioner/ Policy Supervisor: Professor Stephen Jan
Priority Area: Health economics

Screening for domestic violence is a public health intervention introduced in NSW Health to identify domestic violence early, promote awareness, ensure safety for women and children and provide appropriate referrals connecting women with services. This research aims to:1. Identify if women who have disclosed domestic violence whilst pregnant are receiving universal child health services when they go home with their baby.2. Identify any barriers to them receiving these services.3. Develop a best practice model facilitating access to child health services for new mothers experiencing domestic violence.The results of this research will be used to inform policy and practice.

PhD Supervisor: Dr Joanne Spangaro
Health Practitioner/ Policy Supervisor: Ms Lorna McNamara
Priority Area: Health systems research

This PhD will focus on anxiety and depression among cancer patients, from an economics perspective, by exploring three questions:1. How does anxiety and depression affect cancer patients’ use of health services?2. What is the most cost effective approach to implement a clinical care pathway aimed to identify and manage anxiety and depression in cancer patients?3. Do cancer patients have preferences for how anxiety and depression are identified and managed?

PhD Supervisor: Professor Rosalie Viney
Health Practitioner/ Policy Supervisor: Dr Joanne Shaw
Priority Area: Health Economics

The research will study the ethnic differences in women affected with Gestational Diabetes Mellitus, focusing on the differences between European women and those from two ethnicities highly represented in Greater Western Sydney: the Polynesian and South Asian populations.The project aims to compare the prevalence of Gestational Diabetes Mellitus among the various ethnicities represented in Greater Western Sydney and to derive meaningful conclusions from epidemiological data collected in the region.

PhD Supervisor: Professor David Simmons
Priority Area: Epidemiology

The proposed project will aim to determine the number of infections that are caused by various protozoan parasites in NSW (including Giardiasis, Cryptosporidiosis, Blastocystis, Dientamoebiasis and Amebiasis) and will determine the pathogenicity of these illnesses. The second stage of the PhD project will concentrate on the infectious protozoan parasite Giardia intestinalis as it is one of the most important non-viral causes of human diarrhoea in Australia.

PhD Supervisor: Professor John Ellis and Dr Joel Barratt
Health Practitioner/ Policy Supervisor: Dr Stephanie M. Fletcher-Lartey
Priority Area: Epidemiology

Immune Thrombocytopenia is a serious bleeding disorder caused by damage to blood cells called platelets. Platelet destruction is caused by antibodies produced in the body which attack the body’s own platelets.This project will elucidate other ways of how these antibodies destroy platelets and what can be done to stop it. Two mechanisms will be explored: decrease in platelet life span (called apoptosis); and removal of sugars from the platelet surface (called desialylation).

PhD Supervisor: Professor Beng Hock Chong and Dr Jose Perdomo
Priority Area: Translational research