
Australia’s Medical Research Future Fund (MRFF) provided a grant through its Artificial Heart Frontiers Program (AHFP). It aims to support the company’s TAH program and future product enhancements. BiVacor received FDA investigational device exemption to conduct a first-in-human study for the system in November.
The grant comes from a larger grant from MRFF to AHFP totaling approximately $32.9 million. The government wants the program to develop and commercialize devices to treat common forms of severe heart failure and bring new solutions to underserved patients.
BiVacor said the grant will support the clinical work on its TAH as it begins development to integrate wireless power sources. The company plans to begin its FDA IDE study in the first half of this year. It plans to work with Dr. William Cohn and Dr. O.H. Frazier of the Texas Heart Institute for the trial.
“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, BiVacor founder and chief technology officer. “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.”
More about the BiVacor total artificial heart
The company designed BTAH to replace the function of the native heart completely. The long-term therapy, based on rotary blood pump technology, targets patients with severe biventricular heart failure.
Sized similarly to an adult fist, it uses magnetic levitation technology. Left and right vanes are positioned on a common rotor to form the only moving part, a magnetically suspended double-sided centrifugal impeller. BiVacor designed it to create pulsatile outflow by rapidly cycling the rotational speed of the impeller. The non-contact suspension provides large blood gaps to minimize blood trauma and eliminate mechanical wear.
BiVacor plans to eventually pursue further studies to explore short-term and long-term destination therapy as well.