EDAP TMS S.A. Presents at Oppenheimer 36th Annual Healthcare MedTech & Services Conference

Key Highlights for Investors:

• Event Disclosure: On March 18, 2026, EDAP TMS S.A. (“EDAP” or the “Company”) announced its participation at the prestigious Oppenheimer 36th Annual Healthcare MedTech & Services Conference. The Company made available an in-depth investor presentation, which was also webcast and accessible via the Investors section of the corporate website.
• Presentation Focus: The presentation, furnished as Exhibit 99.1 to the SEC filing, highlighted EDAP’s position as a global leader in therapeutic ultrasound, particularly in the treatment of cancer and benign disease through its advanced Focal One® Robotic High-Intensity Focused Ultrasound (HIFU) technology.
• Market Opportunity: EDAP emphasized the large and growing global market opportunity in urology and prostate cancer. The 2022 data from the World Health Organization (Globocan) cites approximately 1.5 million new prostate cancer cases per year worldwide, with significant prevalence in Europe, Asia, and North America.
• Addressing Unmet Needs: The Company’s Focal One® HIFU platform is positioned as a first-line treatment, an option for patients progressing from active surveillance, and as a salvage treatment for prostate cancer. This addresses a substantial underserved patient population seeking alternatives to surgery and radiation, with a strong value proposition in preserving quality of life (urinary and sexual function outcomes) and providing proven efficacy in cancer control.
• Paradigm Shift in Prostate Cancer Therapy: The presentation underlined a shift in treatment preference, with focal therapy (HIFU) gaining rapid adoption, as reflected by Medicare claims data showing it as the fastest-growing treatment option in the US from 2022-2024, outpacing cryotherapy, brachytherapy, and radical prostatectomy.
• Technological Leadership: EDAP’s Focal One® offers best-in-class features, including compatibility with standard OR beds, advanced image-guided treatment planning (MRI, PSMA PET, 3D biopsy integration), dynamic focusing probes, robotic precision, and workflow enhancements such as streaming, recording, and telecollaboration functionalities. The platform is controlled by urologists and can expand into other indications (e.g., endometriosis, not available in all markets).
• Strong Clinical Evidence: The Company cited over 1,000 peer-reviewed publications supporting HIFU for prostate cancer, with clinical outcomes demonstrating the ability to preserve sexual function, maintain urinary control, and achieve effective cancer control—an optimal “trifecta” outcome highly valued by patients and clinicians.
• Favorable Reimbursement Environment: EDAP highlighted a strong reimbursement landscape for HIFU in the US. The 2026 CMS Outpatient Prospective Payment System (OPPS) places HIFU under APC Level 6, maintaining the significant 90% increase in reimbursement first established in 2023. For 2026, the national average Medicare payment for HIFU (CPT code 55880) is \$9,671, which is competitive with or higher than other prostate cancer treatments, including brachytherapy, cryoablation, and robotic prostatectomy.
• Market Penetration and Growth: As of December 31, 2025, the Company reported 41 fixed Focal One® systems in major European hospitals and 254 Focal One® treatment sites. The US market is experiencing rapid momentum, with compounded annual growth rates (CAGR) of 44% for Focal One installations and 52% for procedures performed between 2021 and 2025.
• Financial Performance: The Company reported accelerated revenue growth driven by both capital sales and recurring revenue from disposables and service contracts. Preliminary, unaudited 2025 results and 2026 financial guidance (as of January 12, 2026) point toward robust annual HIFU revenue expansion, reflecting increased adoption and utilization.
• Diversified Platform and Future Growth: EDAP’s robotic HIFU platform addresses large addressable markets in men’s and women’s health, including prostate cancer, benign prostatic hyperplasia (BPH), endometriosis, and other indications such as thyroid nodules, breast cancer, and liver cancer.
• Experienced Leadership: The Company reiterated its management team’s strong track record, with leadership experience from industry-leading MedTech organizations.

Potential Price-Sensitive Information for Shareholders

• Rapid US Adoption and Reimbursement: The clear evidence of strong Medicare reimbursement and rapid adoption growth in the US could materially improve EDAP’s financial outlook and valuation.
• Expansion into New Indications: The Company’s platform is ready for expansion into additional therapeutic areas, potentially unlocking new revenue streams and increasing total addressable market.
• Financial Guidance and Revenue Momentum: Ongoing robust revenue growth and positive financial guidance may positively impact investor sentiment and share valuation.
• Clinical Validation: The large volume of clinical data supporting the efficacy and safety of Focal One® HIFU may accelerate adoption, further enhancing long-term shareholder value.

Summary for Investors

EDAP TMS S.A. is demonstrating strong operational and financial momentum as a leader in robotic HIFU solutions, with expanding market penetration, favorable reimbursement, and a robust portfolio of clinical evidence. The Company is well-positioned to capture further growth in urology and beyond, driven by a differentiated, non-invasive technology and a proven management team. These developments, particularly the US reimbursement environment and rapid adoption rates, are likely to be price sensitive and should be closely monitored by investors.

Disclaimer: The information presented is a summary and interpretation of EDAP TMS S.A.’s public disclosures and investor materials as of March 18, 2026. This article is not financial advice. Investors should conduct their own due diligence and consult with professional advisors before making investment decisions. All forward-looking statements are subject to risks and uncertainties.

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