HeartWise · Artificial Right-Heart without External Power from Bench-to-Bedside

Addressing right ventricular (RV) failure through mechanical circulatory support remains an intricate challenge, impacting patients' overall Quality of Life. Existing solutions are hindered by exorbitant costs, intricate device setups, infection risks, limited blood flow control, and hemocompatibility. Additionally, all patients with left ventricular assist devices face the risk of chronic RV failure. Despite a substantial untapped market for adult RV failure, there remains a critical gap in clinically-approved mechanical assist devices. The HeartWise initiative aims to revolutionize RV support with a dedicated device tailored to disease and eliminating the need for external power sources or control units. HeartWise builds upon two societally viable early-stage ERC-PoC technologies initially developed for the niche yet humanitarian pediatric device market. We aim to extend their application to adult disease markets, beginning with the MENA and European regions. The project integrates these two PoC technologies: circulation support devices that operate without external power AND patient-specific customized cardiovascular surgical planning. HeartWise aims to advance a revolutionary, fully implantable MCS prototype, akin to an artificial mechanical heart, for practical clinical implementation. This disruptive innovation marks a significant departure in ventricle assist devices, as it operates autonomously within the body without reliance on external power. Offering powerless circulatory support and globally accessible interactive patient-specific hemodynamic customization through the internet, we aim to scale-up these technologies to penetrate adult cardiovascular disease markets. Notably, it addresses a substantial market, serving a significant number of adult right heart failure patients. Our strategy involves rigorous testing, refinement of business prospects, and close collaboration with EU stakeholders.