AngioSafe

Executive Summary

AngioSafe is a privately held medical device company headquartered in San Francisco, California, founded in 2018. The company is focused on addressing a critical unmet need in the cardiovascular space: the treatment of severely or totally occluded arteries. Its proprietary Atheroplasty™ platform, led by the Santreva™-ATK System, offers a novel, wire-free, single-step solution for crossing and preparing such challenging lesions. This technology aims to simplify complex endovascular procedures, potentially reducing procedure time, complications, and the need for multiple devices. Chronic total occlusions (CTOs) remain a significant clinical challenge, and current crossing techniques often fail or require extensive experience. AngioSafe's differentiated approach could expand the treatable patient population and improve outcomes. As a pre-revenue company with no disclosed funding rounds, AngioSafe likely operates at an early clinical or preclinical stage. The company's success hinges on demonstrating safety and efficacy in human trials, securing regulatory clearances, and attracting partnerships or investment. Given the large addressable market in peripheral and coronary CTO interventions, positive clinical data could position AngioSafe for rapid adoption. However, the lack of publicly available milestones and financial backing suggests higher risk. The next 12-24 months will be critical for validating the technology and progressing toward commercialization.

Upcoming Catalysts (preview)

• Q4 2026First-in-human clinical data for Santreva-ATK System60% success
• Q2 2027FDA Breakthrough Device designation or similar regulatory milestone50% success
• Q1 2027Series A funding round or strategic partnership40% success