BiVACOR

BiVACOR is a clinical-stage medical device company developing the BiVACOR Total Artificial Heart (BTAH), designed to be the first long-term therapy for patients with severe biventricular heart failure. The BTAH is an implantable artificial heart based on rotary blood pump technology that utilizes magnetic levitation. Similar in size to an adult fist, it is designed to be small enough for implantation in many women and some children, yet capable of providing sufficient cardiac output for an adult male undergoing exercise.

The BTAH features left and right vanes positioned on a common rotor, forming the only moving part - a magnetically suspended double-sided centrifugal impeller. Despite lacking valves or flexing ventricle chambers, the device creates pulsatile outflow by rapidly cycling the rotational speed of the impeller. The non-contact suspension provides large blood gaps, minimizing blood trauma and eliminating mechanical wear, offering a durable, reliable, and biocompatible heart replacement.

In November 2023, the FDA granted BiVACOR an investigational device exemption (IDE) to commence the first-in-human Early Feasibility Study (EFS) for the BTAH. The EFS will evaluate the safety and feasibility of the BTAH as a bridge to heart transplant for patients with biventricular heart failure, initially enrolling three patients at the Texas Heart Institute.

In February 2024, BiVACOR received a USD 13 million grant from the Australian Government's Medical Research Future Fund through the Artificial Heart Frontiers Program to support the BTAH program and future product enhancements, including the integration of wireless power sources.