Overview

BiVACOR is a clinical-stage medical device company developing the BiVACOR Total Artificial Heart (TAH) to replace a failing heart. The device is a compact, titanium implant that uses a single magnetically levitated rotor to pump blood to the lungs and the rest of the body, eliminating valves and mechanical bearings to reduce blood damage. It serves as a bridge-to-transplant and aims to become a long-term (permanent) alternative to heart transplantation. BiVACOR operates in the cardiovascular medtech space, pursuing regulatory approval through preclinical and clinical trials, including an FDA Breakthrough Device Designation and an Early Feasibility Study. Its strategy includes expanding from Australia to the US, securing funding, and advancing toward commercialization to address the large unmet need in end-stage heart failure.