Press Releases

Press Releases

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Toggle Summary EDAP Announces FDA Breakthrough Device Designation for Focal One® in the Treatment of Deep Infiltrating Rectal Endometriosis
Focal One HIFU has potential to address large market impacting thousands of women each year LYON, France, March 4, 2024 - EDAP TMS SA (Nasdaq: EDAP), the global leader in robotic energy-based therapies, announced today that its Focal One platform has been granted Breakthrough Device designation by
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Toggle Summary EDAP Announces Record Preliminary Fourth Quarter and Full-Year 2023 Revenues
Record full-year 2023 preliminary unaudited revenue of EUR 60.4 million ($65.4 million USD), an increase of 9.6% over full-year 2022, driven by 31.7% HIFU growth Record Q4 2023 preliminary unaudited revenue of EUR 19.6 million ($21.3 million USD), an increase of 24.8% over for Q4 2022, driven by
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Toggle Summary EDAP Announces Completion of Enrollment in Phase 3 Study Evaluating Focal One HIFU Therapy for the Treatment of Deep Infiltrating Rectal Endometriosis
60 Patients Completed Enrollment in Under 9 Months Study Results Expected in the Second Half of 2024 LYON, France, February 1, 2024 - EDAP TMS SA (Nasdaq: EDAP), the global leader in robotic energy-based therapies, announced today that it has completed enrollment in its Phase 3 study (Endo-HIFU-R2)
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Toggle Summary EDAP Announces Preliminary Fourth Quarter Record Focal One® System Sales and Placements
Company reports preliminary placement results of twelve Focal One Systems, inclusive of ten capital sales LYON, France, January 8, 2024 - EDAP TMS SA (Nasdaq: EDAP), (“EDAP”), the global leader in robotic energy-based therapies, announced today preliminary Focal One placement results for the fourth
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Toggle Summary EDAP Appoints Ken Mobeck, Global Chief Financial Officer, and Francois Dietsch, Global Chief Accounting Officer
   LYON, France, January 2, 2024 - EDAP TMS SA (Nasdaq: EDAP), (“EDAP”), the global leader in robotic energy-based therapies, today announced that the Company has appointed Ken Mobeck as its Chief Financial Officer of EDAP worldwide, and Francois Dietsch as Global Chief Accounting Officer.
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Toggle Summary EDAP Announces Positive Opinion for Reimbursement from the French National Authority for Health (HAS) for HIFU treatment of Prostate Cancer
Represents Key Milestone Toward Universal Coverage for Focal One HIFU in France LYON, France, December 12, 2023 - EDAP TMS SA (Nasdaq: EDAP), (“EDAP”), the global leader in robotic energy-based therapies, today announced that the French National Authority for Health (“HAS”) released a favorable
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Toggle Summary EDAP Appoints Lance Willsey, M.S., M.D. to Board of Directors
LYON, France, December 6, 2023 -- EDAP TMS SA (Nasdaq: EDAP) (“the Company” or “EDAP”), the global leader in robotic energy-based therapies, today announced the appointment of Lance Willsey, M.S., M.D. to its Board of Directors. Dr. Willsey replaces Dr. Argil Wheelock who has resigned as director
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Toggle Summary EDAP Receives 2023 Industry Category Award from the French National Institute for Intellectual Property (INPI) for Its Therapeutic Ultrasound Technology
LYON, France, November 30, 2023 - EDAP TMS SA (Nasdaq: EDAP), (“EDAP”), the global leader in robotic energy-based therapies, today announced that is has received the Industry Category Award from the French National Institute for Intellectual Property (INPI) based on the Company’s innovative
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Toggle Summary EDAP to Present at Piper Sandler’s 35th Annual Healthcare Conference
LYON, France, November 20, 2023 -- EDAP TMS SA (Nasdaq: EDAP) (“the Company”), the global leader in robotic energy-based therapies, today announced that Ryan Rhodes, Chief Executive Officer, is scheduled to deliver a presentation and host 1x1 investor meetings at the Piper Sandler 35 th Annual
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Toggle Summary EDAP Announces Third Quarter 2023 Financial Results
- Strong Q3 2023 U.S. Focal One ® HIFU procedure growth of +150% year-over-year - - Record nine months HIFU revenues reflecting growing demand - - Two additional Focal One systems already placed in the fourth quarter - - Announces immunotherapy clinical research collaboration with Mount Sinai,
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