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EDAP TMS (EDAP) investor relations material

EDAP TMS H.C. Wainwright 27th Annual Global Investment Conference summary

Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.
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H.C. Wainwright 27th Annual Global Investment Conference summary9 Sep, 2025

Strategic focus and business transformation

  • Shifted strategy to focus exclusively on HIFU, de-emphasizing lithotripsy and distribution segments.

  • Launched FocalOne-i, an advanced HIFU platform with multi-source imaging and AI integration.

  • Achieved 77% year-over-year HIFU revenue growth and increased guidance for 2024.

  • Secured a €36 million credit facility from the European Investment Bank to support HIFU investments.

  • Transitioning to domestic filer status on NASDAQ effective January 1.

Market opportunity and adoption

  • Prostate cancer is the largest cancer in men, with cases expected to double by 2040.

  • FocalOne addresses the treatment gap between active surveillance and radical interventions.

  • HIFU adoption is accelerating, with over 70 systems installed and major hospitals purchasing additional units.

  • Focal therapy market is expanding as data shows HIFU growth outpacing other treatments.

  • Active surveillance trends create a timely opportunity for HIFU as men transition to treatment.

Clinical data and outcomes

  • HiFi study (3,328 patients, 46 centers) demonstrated non-inferior cancer control and superior functional outcomes for HIFU.

  • FARP RCT showed equivalent oncologic control and better preservation of urinary and sexual function compared to surgery.

  • 25% of patients randomized for surgery in FARP opted for HIFU instead.

  • Additional studies and data are expected to further validate HIFU efficacy.

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Frequently asked questions

EDAP TMS S.A. is a medical technology company specializing in the development, manufacturing, and distribution of minimally invasive therapeutic ultrasound devices. The company focuses on treatments for urological conditions, particularly prostate diseases, using high-intensity focused ultrasound (HIFU) technology. EDAP’s products include devices for prostate ablation and lithotripsy, providing non-invasive treatment options that reduce recovery times and side effects for patients. The company markets its products to hospitals and clinics globally, supporting advancements in therapeutic ultrasound technology. The company is headquartered in Lyon, France, and its shares are listed on the NASDAQ.

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