BiVACOR Awarded $13M to Support Total Artificial Heart Trials

BiVACOR was awarded $13 million from the awarded from the Australian Government’s Medical Research Future Fund (MRFF) grant through the Artificial Heart Frontiers Program (AHFP) to support the company’s Total Artificial Heart (TAH) program and future product enhancements.
 
The award will support clinical work for the BiVACOR TAH and start development for integration of wireless power sources for the device. The company expects to begin a U.S. Food and Drug Administration (FDA)-granted investigational device exemption (IDE) first-in-human early feasibility study (EFS) for the TAH in the first half of 2024.
 
The AHFP, led by Australia’s Monash University, is a consortium of Australian research centers in partnership with BiVACOR. The $13 million grant comes from a larger $50 million grant from the MRFF to the AHFP to develop and commercialize devices to treat common forms of severe heart failure and bring technology to underserved patients.
 
“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,” said Daniel Timms, Ph.D., BiVACOR’s founder and chief technology officer. “We are honored 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. 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.”
 
The company named former BioVentrix CEO Jim Dillon as its new leader in January 2024.