CathWorks

Executive Summary

CathWorks is a digital health and medical device company pioneering the FFRangio® System, an AI-powered platform that enables wire-free, drug-free fractional flow reserve (FFR) analysis from routine coronary angiograms. This technology provides interventional cardiologists with real-time, intraprocedural assessment of the entire coronary tree, aiming to improve treatment decisions and patient outcomes while reducing reliance on invasive pressure wires and vasodilators. Founded in 2013 and headquartered in Irvine, CA, the company operates at the intersection of cardiovascular care, medical devices, and digital health, with a focus on enhancing workflow efficiency in catheterization labs. The FFRangio® System addresses a significant unmet need in coronary artery disease assessment by offering a non-invasive alternative to traditional FFR measurement, which requires additional equipment and drugs. With growing adoption of AI in healthcare and increasing emphasis on value-based care, CathWorks is well-positioned to capture market share in the global PCI planning and diagnostic angiography market. The platform's ability to provide comprehensive physiological data without extra steps or risk could streamline procedures and reduce costs. As the company scales commercial efforts, key milestones include clinical evidence generation, regulatory expansions, and strategic partnerships to drive adoption.

Upcoming Catalysts (preview)

• Q3 2026FDA approval for expanded indications (e.g., left main coronary artery assessment)70% success
• Q2 2026Publication of pivotal clinical trial results demonstrating superiority over standard FFR80% success
• Q4 2025Strategic partnership or distribution agreement with a major cardiovascular device company60% success