EDAP TMS (FOCL) Investor Day 2026 summary

Strategic transformation and market leadership

• Transitioned to a pure-play robotic focal therapy company, discontinuing non-core operations to focus on high-growth HIFU markets.

• Three strategic pillars: scaling commercial execution in prostate cancer, expanding indications (BPH, endometriosis), and advancing technological innovation.

• Focal One platform positioned as the global leader in therapeutic ultrasound for organ-sparing, function-preserving cancer and benign disease treatment, targeting a $4B addressable market in prostate cancer.

• Installed base exceeds 175 systems globally, with strong adoption in top academic and community hospitals in the US and Europe.

• Commercial strategy emphasizes physician training, patient demand generation, and program independence to drive utilization and growth, with less than 10% market penetration signaling significant growth runway.

Clinical evidence and guideline evolution

• Landmark HIFI study and other trials demonstrated non-inferior cancer control to surgery, with superior preservation of urinary and sexual function.

• FARP and HIFU-SA studies further validate efficacy and quality-of-life benefits, supporting guideline inclusion in Europe and growing U.S. acceptance.

• Focal therapy now included in European guidelines without registry requirements; rapid increase in publications and academic adoption.

• HIFU is the fastest-growing focal therapy, now the leading ablation technology for prostate cancer, expected to capture ~40% of the market.

• Integration of advanced imaging (MRI, PSMA PET) and AI-driven mapping enhances patient selection and treatment precision.

Innovation and technology roadmap

• Investments in advanced imaging, AI, and remote connectivity (Focal Connect/FocalConnect) enable telecollaboration and scalable training.

• Collaboration with Telix Pharmaceuticals to integrate PSMA PET for improved targeting and outcomes.

• Expanding platform capabilities to include non-thermal histotripsy, leveraging 30+ years of ultrasound expertise.

• Focal One system offers a fully digital, software-driven workflow, enabling efficient, reproducible, and minimally staffed procedures.

• Ongoing development of intellectual property to protect combined HIFU and histotripsy modalities.