Consortium to develop and commercialise world-first durable total artificial heart

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

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.

The consortium said it seeks to take this new technology to market within the six-year duration of the funding program. 

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 consortium has already engaged partners across Australia, Asia-Pacific, the US 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,” said Professor David Kaye, heart failure research laboratory Lead at Monash University and lead of the Artificial Heart Frontiers Program. 

“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 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, the 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.”