Fastwave Medical

Executive Summary

Fastwave Medical is a pre-clinical stage medical device company developing next-generation intravascular lithotripsy (IVL) systems for treating calcific artery disease in coronary and peripheral arteries. Founded in 2018 and headquartered in Burlington, Massachusetts, the company aims to address significant unmet needs in a large and growing market. IVL technology uses sonic pressure waves to fracture calcium deposits, improving vessel compliance for balloon angioplasty and stenting. Fastwave's systems are designed to offer advantages over existing IVL devices, such as enhanced energy delivery and ease of use. The company is currently in the pre-clinical phase, focusing on device design optimization and initial benchtop and animal studies to demonstrate safety and efficacy. As a private company with no disclosed funding rounds, Fastwave faces the typical challenges of early-stage medtech: securing capital for regulatory submissions and clinical trials. However, the strong market demand for less invasive calcium modification solutions and the proven commercial success of first-generation IVL devices (e.g., Shockwave Medical) provide a favorable landscape. Fastwave's success hinges on achieving key technical milestones and attracting strategic partnerships or venture funding to advance toward first-in-human studies.

Upcoming Catalysts (preview)

• Q3 2026Completion of preclinical bench and animal studies70% success
• Q4 2026Series A funding round or strategic partnership announcement50% success
• Q2 2027First-in-human (FIH) clinical trial initiation30% success