Monash, BiVACOR-led consortium to develop and commercialise world-first durable total artificial heart
- A national consortium of universities, hospitals and industry, led by Monash University and BiVACOR, are looking to develop and commercialise a world-first durable Total Artificial Heart.
- Heart failure is an epidemic that impacts more than 300,000 Australians. There is a clear gap in the market for patient-friendly devices to provide a solution to this chronic health challenge.
- The research team seeks to take this new artificial heart technology to market within the six-year duration of MRFF Frontiers program.
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A consortium of universities, hospitals and industry, led by Monash University and BiVACOR, have received $1 million in Federal Government funding to develop and commercialise a world-first durable Total Artificial Heart.
Made possible through funding from the Federal Government’s Medical Research Future Fund (MRFF), the Artificial Heart Frontiers Program will develop and commercialise these new devices through the use of novel, innovative technology applied to this global health problem.
Importantly, the research team seeks to take this new technology to market within the six-year duration of the MRFF Frontiers program. Through this program, the research team hopes to save lives, create jobs, and establish Australia as a worldwide leader in the medical device sector.
A healthy heart supplies the body with the right amount of blood at the rate needed to work well. If disease or injury weakens the heart, the body’s organs will not receive enough blood to work normally.
The BiVACOR Total Artificial Heart is an implantable total artificial heart based on rotary blood pump technology. Similar in size to an adult fist, it is small enough to be implanted in many women and some children yet capable of providing enough cardiac output to an adult male undergoing exercise.
The design, using magnetic levitation (MAGLEV) technology - the same principle used in high-speed trains - includes left and right vanes positioned on a common rotor to form the only moving part, a magnetically suspended double-sided centrifugal impeller.
The team has already engaged partners across Australia, Asia-Pacific, USA and Europe, established regulatory approval pathways, and recently closed a $19 million Series B to fund the company’s preclinical verification activities and the addition of key team members to support the first in-human studies.
“The Artificial Heart Frontiers Program will apply cutting-edge ideas and technology to develop and commercialise new-to-world applications to support all patients with heart failure. This will be achieved initially with our Australian-born, innovative BiVACOR Total Artificial Heart, which is a complete replacement for a native heart,” Professor David Kaye, Heart Failure Research Laboratory Lead at Monash University and Lead of the Artificial Heart Frontiers Program, said.
“This platform technology will then be leveraged in the Artificial Heart Frontiers Program to develop the next-generation of devices to support more patients with heart failure. This will provide a suite of devices for heart support to the Australian and global population.”
More than 300,000 Australians are estimated to live with heart failure, with an additional 30,000 new cases diagnosed every year.
Heart failure is a global pandemic affecting at least 26 million people worldwide and increasing in prevalence. It is the second leading cause of death in the US and Europe kills 118 Australians daily - or one every 12 minutes - and costs the Australian economy more than $5 billion each year.
The huge discrepancy between supply and demand for donor hearts necessitates the use of mechanical circulatory support devices that assist or take over the blood-pumping function of the native heart as either a permanent alternative to transplant or until a donor heart is received.
The majority of patients suffer left ventricular failure, and receive support from left ventricular assist devices (LVADs). LVADs leave the heart in place and provide support to only the left ventricle.
However, many patients also suffer from right ventricular heart failure, and the lack of durable total heart support devices mean these patients receive suboptimal or no support, and unfortunately succumb to their condition.
The BiVACOR-created Total Artificial Heart has world-first technology including an optimised hydraulic system to support both sides of the heart, powerful magnetic levitation and rotation systems that significantly enhances durability and biocompatibility, small device size to support more patients, and flow adaptation that responds to patient requirements without user input.
Dr. Daniel Timms, Founder of BiVACOR, said, “no durable, permanent Total Artificial Heart exists clinically for full heart support, thus presenting a clear gap in patient treatment that the research team was keen to fill.
“The smaller size and improved anatomical fitting of our devices will expand the population who are able to be treated by this form of therapy, including women and children. Most importantly, no immunosuppressive drugs are required.
“The quiet operation of our device combined with the smaller, lighter and lower power consumption of the pump controller will provide a less cumbersome experience to the patient. Furthermore, the adaptive nature of the blood flow output from our devices, with the maximum output enabling patients to exercise, will provide for a greatly improved quality of life.”
Dr Shaun Gregory, Senior Research Fellow in the Department of Mechanical and Aerospace Engineering at Monash University, said this project aims to significantly reduce the burden of heart failure in Australia, and globally, through ground-breaking multidisciplinary research that will lead to the development and commercialisation of cutting edge devices that support or replace the heart.
“We hope that at the conclusion of the Artificial Heart Frontiers Program we can create a new medical technology enterprise within Australia through world-leading multidisciplinary research and development, building the capacity and capability for translational research of Australia’s health and medical research sector,” he said.
“We are the right team, with the right technology, at the right time, to lead a new frontier in artificial hearts.”
The Artificial Heart Frontiers Program involves a consortium of partners including Monash University, BiVACOR, The University of Queensland, The University of Sydney, The University of New South Wales, Griffith University, Baker Heart and Diabetes Institute, One Ventures Pty Ltd, The Alfred & St Vincent’s Hospitals.
BiVACOR® is a preclinical stage medical device company developing the BiVACOR Total Artificial Heart (TAH), the first long-term therapy for patients with severe heart failure. The TAH is designed to replace the complete function of the native heart and address the global unmet need of patients with end-stage heart failure (HF) by providing a life-extending solution.
Headquartered in Houston, TX, with an engineering office in Cerritos, CA, and an international office in Brisbane, Australia, BiVACOR was founded in 2008 by a team of internationally renowned biomedical engineers and cardiac surgeons. CEO/CTO Daniel Timms, Ph.D., leads the organization along with Chief Medical Officer William Cohn, MD, and is supported by a scientific advisory board composed of veteran surgeons, inventors, and researchers devoted to developing technologies to fix or replace the human heart.
Today, BiVACOR has a robust collaborative network that extends nationally and internationally and boasts a team of world-class engineers, medical specialists, and business executives fervent to advance this ground-breaking technology.
The company benefits today from six patents and patent applications.
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