EvaHeart

Executive Summary

EvaHeart, Inc. is a Houston-based medical device company developing the EVAHEART®2 Left Ventricular Assist Device (LVAD) for patients with advanced heart failure. Unlike traditional continuous-flow LVADs, the EVAHEART®2 uses a centrifugal pump designed to preserve native pulsatility, potentially reducing complications such as gastrointestinal bleeding and aortic insufficiency. The device is currently undergoing a pivotal clinical trial in the United States to support FDA approval for the North American market. With its differentiated technology and a growing addressable market of over 200,000 advanced heart failure patients, EvaHeart is positioned to compete with established players like Abbott and Medtronic. The company's success hinges on positive trial data and regulatory clearance, which could unlock significant commercial opportunity. EvaHeart remains privately held and has not disclosed recent funding rounds, suggesting a potential need for capital to support commercialization.

Upcoming Catalysts (preview)

• Q4 2026Pivotal trial completion and data readout75% success
• Q1 2027FDA premarket approval (PMA) submission65% success
• H2 2026Partnership or distribution agreement for US market50% success