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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.
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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