Total Artificial Heart to be commercialised by Monash and BiVACOR

Total Artificial Heart

A consortium of universities, hospitals and industry have received $1 million in federal government funding to develop and commercialise a durable Total Artificial Heart, led by Monash University and BiVACOR. 

Through the federal government’s Medical Research Future Fund (MRFF), the Artificial Heart Frontiers Program will develop and commercialise these new devices to remedy this global health problem. 

The research team seeks to take this new technology to market within the six-year duration of the MRFF Frontiers program. Through the program the research team hopes to save lives, create jobs and establish Australia as a worldwide leader in the medical device sector. 

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.  

Using magnetic levitation (MAGLEV) technology – the same used in high-speed trains – the design includes left and right vanes positioned on a common rotor to form the only moving part. This is a magnetically suspended, double-sided centrifugal impeller. 

Partners across Australia, Asia-Pacific, USA and Europe have been engaged and regulatory approval pathways have been established. The team has also 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,” Monash University Heart Failure Research Laboratory lead and Artificial Heart Frontiers Program lead Professor David Kaye said. 

“This will be achieved initially with our Australian-born, innovative BiVACOR Total Artificial Heart, which is a complete replacement for a native heart. 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.”  

The huge discrepancy between supply and demand for donor hearts necessitates the use of mechanical circulatory support devices, to assist or take over the blood-pumping function of the native heart as a permanent alternative to transplant, or until a donor heart is received. 

While most patients suffer left ventricular failure and receive support from left ventricular assist devices (LVADs), many patients also suffer from right ventricular heart failure. The lack of durable total heart support devices means these patients receive little to no support. 

The BiVACOR Total Artificial Heart includes an optimised hydraulic system to support both sides of the heart, powerful magnetic levitation and rotation systems that significantly enhances durability and biocompatibility. It is also small, so it supports more patients, and has flow adaptation that responds to patient requirements without user input. 

“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,” BiVACOR founder Dr Daniel Timms said. 

“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,” he said. 

The Artificial Heart Frontiers Program aims to significantly reduce heart failure in Australia and worldwide through multidisciplinary research, leading to the development and commercialisation of devices to support or replace the heart, Monash University Department of Mechanical and Aerospace Engineering senior research fellow Dr Shaun Gregory said. 

“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,” Gregory said. 

“Building the capacity and capability for translational research of Australia’s health and medical research sector. 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’s other partners include University of Queensland, University of Sydney, University of NSW, Griffith University, Baker Heart and Diabetes Institute, One Ventures Pty Ltd, The Alfred & St Vincent’s Hospitals.

To discover more about the Total Artificial Heart, click here.