EDAP TMS (NasdaqGM:EDAP) FY Conference Transcript

Summary of EDAP TMS FY Conference Call Company Overview - Company: EDAP TMS - Industry: Medical Devices, specifically focused on HIFU (High-Intensity Focused Ultrasound) technology for treating prostate cancer - Key Product: FocalOne platform, with the latest version being FocalOne-i launched in April 2025 [1][3] Strategic Shift - Management has shifted focus entirely to the HIFU business, de-emphasizing lithotripsy and distribution businesses [1][3] - Plans to expand HIFU applications to include endometriosis treatment and benign prostatic hyperplasia (BPH) [1][12] Market Opportunity - Prostate cancer is the most diagnosed cancer in men globally, with nearly 1.5 million cases annually, projected to double by 2040 [4] - The market for prostate cancer treatment is expected to grow significantly, with an increase in mortality rates [4] - FocalOne addresses a gap in treatment options between active surveillance and radical treatments, providing a less invasive alternative [5][6] Product Features and Clinical Data - FocalOne-i features a five-axis robotic positioning system and is compatible with various imaging technologies, including AI [3][4] - HIFU is showing exponential growth, while traditional treatments like cryoablation and surgery are stagnating [8] - The HiFi study, involving 3,328 patients, demonstrated superior functional outcomes for HIFU compared to traditional surgery [10][11] - A randomized controlled trial (FARP) showed that 25% of patients opted for FocalOne HIFU over surgery, indicating strong patient preference [11] Financial Performance - Reported a 77% increase in HIFU revenues year-over-year for Q2 2025 [15] - Increased guidance for HIFU revenue growth, indicating confidence in the strategic shift [17] Reimbursement and Market Access - Anticipated 5.6% increase in facility payment levels from CMS starting January 1, 2026, which is expected to enhance hospital investment in HIFU [18][19] - Hospitals are recognizing the ROI of investing in FocalOne due to its efficacy and quality of life outcomes for patients [18] Future Developments - Clinical studies for BPH are expected to begin in early 2026, with a potential labeling change following [21] - CE Mark received for endometriosis treatment, with limited launch currently underway [22] Financial Strategy - Agreement with the European Investment Bank for a €36 million credit facility to support investments in HIFU [23][24] - Transitioning to a domestic filer on NASDAQ effective January 1, 2026, to enhance market presence [26] Conclusion - EDAP TMS is positioned for significant growth in the HIFU market, with a clear strategy focused on expanding treatment applications and improving patient outcomes through innovative technology and clinical validation [1][12][15]