EDAP TMS (EDAP) Piper Sandler 37th Annual Healthcare Conference summary

Market environment and sales dynamics

• Hospitals are under spending constraints, making strategic investments in clinically necessary, premium-priced equipment with strong economic rewards.

• Sales processes are longer due to strategic capital nature, but recent quarters saw 167% growth in capital sales for Focal One.

• U.S. and OUS markets differ; OUS sales are growing, especially in Western Europe, with expanded commercial teams in the U.K., Nordics, and Middle East.

• Clinical value and economic arguments resonate most with customers, supported by growing reimbursement and outpatient procedure status.

• Workflow and value analysis committees are key hurdles, but Focal One is positioned as a leading solution in a fast-growing treatment category.

Clinical evidence and adoption

• Advanced imaging enables better diagnosis and risk stratification, making focal therapy a compelling option for prostate cancer.

• Recent studies (HIFI and upcoming FARP) provide strong evidence for oncologic control and improved patient outcomes, supporting adoption.

• Adoption is in the early adopter phase, with increasing system sales and procedure growth; over 50 top U.S. academic centers have adopted the technology.

• Data from leading centers and ongoing studies are expected to further accelerate adoption.

Indication expansion and strategic focus

• The company is shifting from legacy ESWL business to focus on HIFU, leveraging existing market presence for broader expansion.

• HIFU holds promise for multiple indications beyond prostate cancer, including women’s health and BPH, with feasibility studies underway.

• BPH studies are enrolling in the U.S. and Europe, with plans for multi-center expansion and regulatory engagement; updates expected next year.

• Indication expansion strengthens the value proposition and ROI modeling for hospitals.