Protembis

Executive Summary

Protembis is a German medical device company developing the ProtEmbo Cerebral Protection System, designed to capture and remove embolic debris during transcatheter aortic valve replacement (TAVR) procedures, thereby reducing the risk of procedural stroke and long-term cognitive decline. Founded in 2013 and headquartered in Aachen, the company addresses the significant unmet need for cerebral protection in TAVR, which is increasingly performed in lower-risk patients. The ProtEmbo device features a unique dual-filter design that provides complete coverage of the aortic arch vessels, potentially offering advantages over existing single-filter systems. With CE mark approval already in Europe, Protembis is poised to expand its commercial footprint and advance toward U.S. market entry. The company's near-term focus includes enrolling patients in the PROTEMBO pivotal trial to support FDA approval, with enrollment expected to complete in late 2026. Protembis is also exploring strategic partnerships with major TAVR valve manufacturers to integrate its device into routine practice. Positive clinical outcomes from ongoing studies could drive adoption and reimbursement decisions. As cerebral protection becomes standard of care in TAVR, Protembis is well-positioned to capture a meaningful share of the growing global market, which is projected to exceed $2 billion by 2030.

Upcoming Catalysts (preview)

• H2 2026FDA approval decision for ProtEmbo Cerebral Protection System70% success
• Q3 2026Completion of PROTEMBO pivotal trial enrollment85% success
• 2026Partnership or distribution agreement with a major TAVR manufacturer50% success