BiVACOR is gearing up to commence a first-in-human feasibility study for its total artificial heart. Image credit: Shutterstock/peakanucha.

US-based BiVACOR has been awarded $13m from the Australian Government’s Medical Research Future Fund (MRFF) to advance its total artificial heart programme.

With a presence in Australia, BiVACOR was chosen as part of an A$50m ($33m) grant by the government through the Artificial Heart Frontiers Programme (AHFP).

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Along with the medtech company, five universities and three clinical groups form the Australia-based consortium to develop and commercialise artificial hearts.

BiVACOR stated that the funding will help with the development of a wireless power source for the devices, along with supporting clinical trials.

US-based Syncardia Systems has developed the only total artificial heart approved by the Food and Drug Administration (FDA).

BiVACOR is gearing up to commence a first-in-human feasibility study for its total artificial heart. The device is designed for long-term treatment of patients with severe biventricular heart failure.

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The study (NCT06174103) will test BTAH as an option for patients with heart failure who are awaiting a heart transplant, for which patients can wait nearly three years. Total artificial hearts are used to bridge the time to heart transplantation by substituting the pumping of blood around the body.

The FDA approved the trial with an investigational device exemption. It is slated to start in the first half of 2024, with no estimate of data readout revealed as of yet.

In an email to Medical Device Network, BiVACOR said: “With BiVACOR soon starting its first-in-human cases, it is still being determined at this time on analysis timing/data readout.”

According to a ClinicalTrials.gov entry, the study is estimated to enrol five adult patients. The primary endpoints consist of survival six months after transplant and evaluation of device safety.

Using rotary blood pump technology, the device is small enough to be implanted in women and some children but can produce the same cardiac output as an adult male would when exercising.

BiVACOR draws comparisons to the magnetic levitation technology used in high-speed trains, outlining how a magnetically suspended centrifugal impeller can create pulsatile flow by changing its speed, without the need for valves or flexing chambers.

The global cardiovascular devices market had a value of nearly $60bn in 2023, with it expected to grow to $86.6bn by 2030, according to a report by GlobalData.

BiVACOR’s chief technology officer Daniel Timms said: “The Australian Government’s investment further validates the dire need for innovation in this field. It is a testament to the promise of our technology to bring these life-saving devices to market over the next few years.”