InnovHeart

Executive Summary

InnovHeart, founded in 2015 and headquartered in Milan, Italy, is a private medical device company pioneering the Saturn Transcatheter Mitral Valve Replacement (TMVR) system for mitral regurgitation (MR). MR affects millions globally, yet many patients remain untreated due to the high risks of open-heart surgery. Saturn is designed as a fully percutaneous, transfemoral, transseptal device, aiming to offer a less invasive option with potential for broader patient access. The system's unique delivery approach could address the anatomical challenges that have hindered prior TMVR technologies. InnovHeart is currently advancing through preclinical and early clinical phases, with a focus on demonstrating safety and feasibility. The company's innovative platform positions it to capture a significant share of the expanding transcatheter mitral valve market, projected to exceed $5 billion by 2030. Key near-term milestones include initiating first-in-human studies and securing additional funding to support clinical development and regulatory submissions.

Upcoming Catalysts (preview)

• Q2 2026Initiation of First-in-Human Study for Saturn TMVR75% success
• H2 2026Series B Financing Round60% success
• Q1 2027CE Mark Submission for Saturn TMVR35% success