BiVACOR

Executive Summary

BiVACOR is a private medical device company based in Houston, Texas, developing the BiVACOR Total Artificial Heart (TAH), a biventricular rotary blood pump designed to replace the failing heart in patients with severe heart failure. Heart failure affects over 26 million people worldwide, including 6.2 million in the U.S., yet heart transplants remain limited to a small fraction of patients due to donor shortages. BiVACOR's TAH addresses this critical unmet need by providing a durable, long-term mechanical circulatory support solution that can serve as a bridge to transplant or destination therapy. The device is constructed from a single moving part (a rotating impeller) and is fully implantable, offering potential advantages in durability and reduced thrombogenicity compared to existing pulsatile total artificial hearts. BiVACOR has received FDA approval for an early feasibility study (EFS) and has already performed initial human implants. The company is actively enrolling patients in its EFS in the U.S. and has engaged with leading heart transplant centers. The TAH has also been granted Breakthrough Device designation by the FDA, expediting its regulatory pathway. With a strong intellectual property portfolio and a seasoned management team, BiVACOR is poised to become a leader in the mechanical circulatory support market, which is projected to exceed $2 billion annually. The company's technology has the potential to transform the standard of care for end-stage heart failure, offering a lifeline to thousands of patients who currently have limited options.

Upcoming Catalysts (preview)

• Q3 2026Completion of enrollment for the U.S. Early Feasibility Study (EFS) and release of interim safety and performance data90% success
• Q4 2026FDA approval to initiate a pivotal clinical trial (IDE supplement) for the BiVACOR TAH70% success
• Q4 2026Strategic partnership or licensing agreement with a global cardiovascular device company for commercialization outside the U.S.50% success