EDAP TMS (EDAP) Jefferies London Healthcare Conference 2024 summary

Market opportunity and trends

• Prostate cancer represents a large and growing global market, with nearly 1.5 million new cases annually across six regions and 300,000 new cases in the U.S. alone.

• Focal therapy and HIFU are emerging as significant alternatives to traditional treatments, with HIFU showing strong growth while surgery and other modalities decline.

• Focal therapy is in early adoption, currently at mid-single digit penetration, but is expected to grow rapidly over the next five years, driven by clinical data and guideline changes.

• HIFU is already included in NCCN guidelines for salvage treatment and is poised for broader adoption as new evidence emerges.

• Commercial payer coverage and further guideline updates are key catalysts for accelerating adoption.

Technology and clinical evidence

• Focal One integrates advanced imaging, robotics, and proprietary HIFU technology, enabling precise, efficient, and repeatable prostate cancer treatments.

• The system is compatible with various imaging sources and features a five-axis robotic positioning system and dynamic focusing probe.

• Over 50,000 patients have been treated with HIFU, supported by more than 10,000 peer-reviewed publications.

• The upcoming HIFI study, the largest of its kind, demonstrates equivalent cancer control to surgery with superior functional outcomes, likely to impact market adoption.

• Focal One is installed in leading academic and community hospitals, including 7 of the top 10 U.S. News & World Report hospitals.

Financial and operational highlights

• HIFU business grew 51% year-over-year, improving gross margin by 400 basis points.

• Minimal debt and ongoing investments support top-line growth and market expansion.

• Medicare reimbursement for HIFU will increase by 5.4% effective January 1, with strong physician payment rates and efficient 40–60 minute treatment times.

• Reimbursement is not a barrier to adoption, and the gap between HIFU and surgery professional fees has narrowed over time.

• Focal therapy offers additional billable events for physicians, such as confirmational biopsies and follow-up imaging.