BiVACOR Receives Funding Boost for Total Artificial Heart Clinical Trials

13 March 2024

Pictured: BiVACOR Total Artificial Heart uses magnetic levitation (MAGLEV) technology, the same principle used in high-speed trains. The design includes left and right vanes positioned on a common rotor to form the only moving part, a magnetically suspended double-sided centrifugal impeller. (Photo: https://bivacor.com/#home)

BiVACOR, a clinical stage device company, recently received US$13 million as part of the Artificial Heart Frontiers Program (AHFP), to support the company’s Total Artificial Heart program and future product enhancements.

Led by Monash University, the AHFP is comprised of a consortium of research centres in Australia in collaboration with industry partner BiVACOR. BiVACOR’s grant is part of a larger A$50 million MRFF grant awarded to the AHFP to develop and commercialise devices to treat the most common forms of severe heart failure and bring novel solutions to underserved patients.

The funding will support clinical work of the BiVACOR Total Artificial Heart (TAH) and begin development for the integration of wireless power sources for the device.

MTPConnect has been supporting BiVACOR’s innovation since October 2022, when the company was awarded $750,000 through the Targeted Translation Research Accelerator (TTRA) for diabetes and cardiovascular disease, to develop a new, more portable, external controller to allow long-term use with its TAH. Through the program, BiVACOR’s project is also supported by TTRA partner organisation, Medical Device Partnering Program.

Significant investment into Australia's medtech sector

MTPConnect CEO Stuart Dignam said: “It’s great to see this significant investment into the medtech sector in Australia, and we are excited to be working with BiVACOR through our TTRA program.”

The BiVACOR TAH is designed to be the first long-term therapy for patients with severe biventricular heart failure. The device replaces the native heart and addresses the global unmet need of patients with endstage heart failure by providing a next-generation life-extending solution. It 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.

BiVACOR founder and chief technology officer Dr Daniel Timms says there is a huge gap between available treatment options and the number of patients with severe heart failure.

“Initiating human clinical work for the BiVACOR TAH is the first step to address critical patient needs from this non-curative disease.

“We are honoured to be a part of the Artificial Heart Frontiers Program, working with our close partners: lead institution Monash University, The University of New South Wales, The University of Queensland, and Griffith University, as well as our clinical partners, St. Vincent’s Hospital, Sydney, and The Alfred Hospital,” Dr Timms said.

Validating innovation and bringing lifesaving devices to market

“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 lifesaving devices to market over the next few years.”

Project co-lead and Director of Cardiology at The Alfred, Professor David Kaye, who also leads the Monash Alfred Baker Centre for Cardiovascular Research, says heart failure is a chronic progressive condition in which patients suffer from debilitating symptoms, including persistent breathlessness and fatigue.

“Heart failure patients frequently require hospitalisation at great cost to a patient’s quality of life and the health system. The average survival of a heart failure patient is comparable to some cancers at just five years and is even less for patients with advanced heart failure, who are the people our devices will most benefit,” said Professor Kaye.

An FDA-granted investigational device exemption (IDE) first-in-human Early Feasibility Study (EFS) for BiVACOR’s Total Artificial Heart is slated to begin in the first half of 2024, working with two pioneers and luminaries in cardiovascular surgery, William E. Cohn, MD and O.H. (Bud) Frazier, MD, of the Texas Heart Institute.

Listen to our podcast with BiVACOR's Dr Daniel Timms

We caught up with BiVACOR’s Dr Daniel Timms when we led the Australian delegation to The MedTech Conference in Anaheim California last year – you can hear his incredible story in episode 166 of the MTPConnect Podcast!

BiVACOR is a privately held company with offices located in Brisbane, Australia and California.