BiVACOR

The company's core product is the BiVACOR Total Artificial Heart (TAH), a device designed to completely replace the function of a patient's failing native heart. Unlike previous artificial hearts, the BiVACOR TAH utilizes a single, magnetically levitated spinning rotor to pump blood to both the lungs and the rest of the body. This design, which incorporates magnetic levitation (MAGLEV) technology similar to that used in high-speed trains, eliminates the need for valves or mechanical bearings, which are common points of failure and can damage blood cells. The compact, titanium device is small enough to be implanted in most men, women, and some children, yet powerful enough to support the circulatory needs of an active adult. The system is designed to serve as a bridge-to-transplant, keeping patients alive while they await a donor heart, with the ultimate goal of becoming a long-term, permanent alternative to transplantation.

BiVACOR operates in the medical technology market, specifically targeting the global population suffering from end-stage heart failure, a market with a significant unmet need due to the scarcity of donor hearts. The company's business model revolves around the development, regulatory approval, and eventual commercialization of the TAH. Having expanded from Australia to the US with headquarters in Huntington Beach, California, and offices in Houston, Texas, BiVACOR is actively engaged in clinical trials. The company has secured significant funding through various rounds, including a Series B led by Cormorant Asset Management and OneVentures, and grants from the National Institutes of Health (NIH), to finance preclinical and clinical studies. A major milestone was achieved in July 2024 with the successful first-in-human implantation of the device, part of an FDA-approved Early Feasibility Study. The FDA has also granted the TAH a Breakthrough Device Designation, which is intended to expedite the review and approval process.