EDAP

EDAP Reports Fourth Quarter and Full-Year 2023 Financial Results

Retrieved on: 
Wednesday, March 27, 2024
AAGL, Patient, TMS, Investment, Endometriosis, Therapy, USD, Marketing, Congress, Urology, Teaching hospital, INPI, Food, Prostate cancer, EAU, Cancer, Hospital, Intellectual property, AUA, FDA, Diagnosis, DIE, Growth, EDAP, Operating cost, EDT, Randomized controlled trial

Total revenue in the HIFU business for the fourth quarter of 2023 was EUR 7.5 million (USD 8.1 million), as compared to EUR 5.4 million (USD 5.5 million) for the fourth quarter of 2022.

Key Points: 
  • Total revenue in the HIFU business for the fourth quarter of 2023 was EUR 7.5 million (USD 8.1 million), as compared to EUR 5.4 million (USD 5.5 million) for the fourth quarter of 2022.
  • The increase was driven by 10 Focal One systems sold in the fourth quarter of 2023 versus 7 systems sold in the fourth quarter of 2022.
  • Total revenue in the Distribution business for the fourth quarter of 2023 was EUR 9.9 million (USD 10.7 million), as compared to EUR 6.7 million (USD 7.0 million) for the fourth quarter of 2022.
  • Operating loss for the fourth quarter of 2023 was EUR 3.5 million (USD 3.8 million), compared to an operating loss of EUR 1.6 million (USD 1.6 million) in the fourth quarter of 2022.

EDAP to Announce Fourth Quarter and Full-Year 2023 Financial Results on March 27, 2024

Retrieved on: 
Wednesday, March 13, 2024
Webcast, EDAP, EDT

LYON, France, March 13, 2024 -- EDAP TMS SA (Nasdaq: EDAP) (“the Company”), the global leader in robotic energy-based therapies, today announced that it will release its financial results for the fourth quarter and full-year ended December 31, 2023, before the markets open on Wednesday, March 27th, 2024.

Key Points: 
  • Company to host conference call and webcast on Wednesday, March 27th at 8:30am EDT
    LYON, France, March 13, 2024 -- EDAP TMS SA (Nasdaq: EDAP) (“the Company”), the global leader in robotic energy-based therapies, today announced that it will release its financial results for the fourth quarter and full-year ended December 31, 2023, before the markets open on Wednesday, March 27th, 2024.
  • An accompanying conference call and webcast will be conducted by Ryan Rhodes, Chief Executive Officer, Ken Mobeck, Chief Financial Officer, and François Dietsch, Chief Accounting Officer.
  • Please refer to the information below for conference call dial-in information and webcast registration.

EDAP to Present at the Oppenheimer 34th Annual Healthcare MedTech & Services Conference

Retrieved on: 
Wednesday, March 6, 2024
EDAP, Medtech, Conference

LYON, France, March 6, 2024 -- 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 virtual presentation and host 1x1 investor meetings at the Oppenheimer 34th Annual Healthcare MedTech & Services Conference, which is being held virtually from March 12-13, 2024.

Key Points: 
  • LYON, France, March 6, 2024 -- 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 virtual presentation and host 1x1 investor meetings at the Oppenheimer 34th Annual Healthcare MedTech & Services Conference, which is being held virtually from March 12-13, 2024.

EDAP Announces FDA Breakthrough Device Designation for Focal One® in the Treatment of Deep Infiltrating Rectal Endometriosis

Retrieved on: 
Monday, March 4, 2024
TMS, Woman, Diarrhea, FDA, Quality of life, Tenesmus, Food, DIE, Endometriosis, Quality, Constipation, Dyspareunia, Rectum, Prostate, Fatigue, EDAP, Patient, Diagnosis, MRI, Weakness, Pharmaceutical industry

“This designation reflects the FDA’s recognition that deep infiltrating endometriosis remains a significant unmet medical need in women’s health with few treatment alternatives.

Key Points: 
  • “This designation reflects the FDA’s recognition that deep infiltrating endometriosis remains a significant unmet medical need in women’s health with few treatment alternatives.
  • The Focal One system being granted a Breakthrough Device designation underscores the significance of this innovative development for DIE patients.
  • In January 2022, EDAP reported positive results from the Phase 2 Endo-HIFU-1R study (N=60) evaluating Focal One HIFU for the treatment of deep infiltrating rectal endometriosis, and this data was included in EDAP’s submission in consideration for receiving Breakthrough Device designation from the FDA.
  • In February 2024, EDAP announced the completion of enrollment in a Phase 3 study evaluating Focal One HIFU therapy for the treatment of deep infiltrating rectal endometriosis.

EDAP Announces Record Preliminary Fourth Quarter and Full-Year 2023 Revenues

Retrieved on: 
Thursday, February 29, 2024
Urology, TMS, Growth, EUR, EDAP, Prostate cancer

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

Key Points: 
  • 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 38.8% HIFU growth
    LYON, France, February 29, 2024 - EDAP TMS SA (Nasdaq: EDAP), a global leader in robotic energy-based therapies, today announced preliminary unaudited fourth quarter and full-year 2023 revenues.
  • “Our fourth quarter and full-year 2023 revenues each hit record levels driven by increased demand for Focal One Robotic HIFU and solid execution from our capital sales and regional clinical teams,” said Ryan Rhodes, Chief Executive Officer of EDAP TMS.
  • “During the fourth quarter, we saw growing demand for Focal One from both leading academic and community hospitals across global markets.
  • EDAP expects to release final Fourth quarter and Full-year financial results in March.

EDAP Announces Completion of Enrollment in Phase 3 Study Evaluating Focal One HIFU Therapy for the Treatment of Deep Infiltrating Rectal Endometriosis

Retrieved on: 
Thursday, February 1, 2024
Quality of life, Weakness, EDAP, MRI, Patient, Endometriosis, Tenesmus, TMS, Rectum, Diarrhea, Physician, Dyspareunia, Constipation, Quality, Fatigue, Woman, Pharmaceutical industry

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) evaluating Focal One High-Intensity Focused Ultrasound (HIFU) therapy for the treatment of deep infiltrating rectal endometriosis.

Key Points: 
  • 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) evaluating Focal One High-Intensity Focused Ultrasound (HIFU) therapy for the treatment of deep infiltrating rectal endometriosis.
  • The ongoing Phase 3 study ( NCT05755958 ) is a comparative, randomized, double blind trial, with the primary objective of evaluating acute pelvic pain levels in 60 patients.
  • In January 2022, EDAP reported positive results from the Phase 2 Endo-HIFU-1R study (N=60) evaluating Focal One HIFU for the treatment of deep infiltrating rectal endometriosis.
  • The study also evaluated the effect of HIFU treatment on endometriosis symptoms and Quality of Life (QoL).

EDAP Announces Preliminary Fourth Quarter Record Focal One® System Sales and Placements

Retrieved on: 
Monday, January 8, 2024
Patient, Google Images, Calendar, Prostate cancer, Urology, Federal Medical Centres, EDAP, Medical imaging

Company reports preliminary placement results of twelve Focal One Systems, inclusive of ten capital sales

Key Points: 
  • 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 quarter of calendar year 2023.
  • The Company experienced robust demand for its Focal One robotic HIFU technology, placing twelve Focal One systems, inclusive of ten capital sales.
  • Additionally, it was a record quarter for sales of ExactVu™ Micro-Ultrasound systems used for prostate biopsy.
  • “Our Focal One commercial team continues to gain significant momentum as reflected by our record-setting number of capital sales as well as overall system placements in the fourth quarter of 2023,” said Ryan Rhodes, Chief Executive Officer of EDAP.

EDAP Appoints Ken Mobeck, Global Chief Financial Officer, and Francois Dietsch, Global Chief Accounting Officer

Retrieved on: 
Tuesday, January 2, 2024
EDAP

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.

Key Points: 
  • 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.
  • Both appointments are effective as of January 1, 2024.
  • “Based on Ken’s extensive experience in global finance, investor relations and operations, this appointment to Global Chief Financial Officer is consistent with our ongoing alignment and will enable EDAP to remain focused on executing our current growth strategy while also increasing our visibility amongst U.S. investors.
  • Consistent with these changes, we also believe the timing is now ideal for establishing a formal, officer-level position for our global accounting function, and based upon Francois’ impressive record of accomplishment and experience with EDAP, I am pleased that he will now serve as our Global Chief Accounting Officer.”

EDAP Announces Positive Opinion for Reimbursement from the French National Authority for Health (HAS) for HIFU treatment of Prostate Cancer

Retrieved on: 
Tuesday, December 12, 2023
Risk, Physician, Radiation, Social Security, Prostate cancer, Social, EDAP, Safety, Patient

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 recommendation for the reimbursement of high-intensity focused ultrasound (HIFU) therapy in the treatment of prostate cancer.

Key Points: 
  • 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 recommendation for the reimbursement of high-intensity focused ultrasound (HIFU) therapy in the treatment of prostate cancer.
  • The positive opinion from HAS is an important milestone along the regulatory pathway of securing final reimbursement in France.
  • More specially, the favorable opinion relates to HIFU as a primary treatment of intermediate risk localized prostate cancer as well as a salvage option after failed radiotherapy.
  • Based on this positive opinion from the HAS, the French Social Security authorities can now use this recommendation for including HIFU procedures in its next cycle to determine the procedure’s reimbursement rate and the timing for when such reimbursement would go into effect.

EDAP Appoints Lance Willsey, M.S., M.D. to Board of Directors

Retrieved on: 
Wednesday, December 6, 2023
Hospital, Family, Friends, Prostate cancer, Cancer, EDAP, Patient, Therapy, Pleasure

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.

Key Points: 
  • 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.
  • “I appreciate the opportunity to join the board of EDAP, where the company’s Focal One Robotic HIFU platform is changing the treatment paradigm in the management of prostate cancer,” said Dr. Lance Willsey.
  • I am convinced he will be a great addition to our board of directors and will contribute significantly to the company’s development and its shareholder value.”
    Dr. Lance Willsey, M.S., M.D.
  • His contribution and commitment have been key in the development of the value of our company”, continued Marc Oczachowski, Chairman of the Board.