EDAP TMS SA - EDAP STOCK NEWS

EDAP TMS reported a record revenue of EUR 15.3 million ($18.3 million) for Q4 2020, a 28% increase from Q4 2019. This growth was fueled by a 50% rise in HIFU device sales, with eight devices sold during the quarter. Despite the ongoing COVID-19 pandemic, the company experienced sequential quarterly revenue growth throughout 2020. However, the total revenue for 2020 is projected at EUR 41.6 million ($47.8 million), a 7% decline compared to 2019 due to pandemic-related restrictions. The full-year results will be disclosed in March 2021.

EDAP TMS SA announced that Marc Oczachowski, President and CEO, will participate in a fireside chat at the B. Riley Securities Virtual Oncology Investor Conference on January 20, 2021, at 10:00 a.m. ET. An audio webcast will be available for replay on the EDAP investor website for 90 days. EDAP is recognized as a global leader in robotic energy-based therapies, focusing on minimally invasive medical devices for various conditions, including prostate cancer. The company’s Robotic HIFU devices and ExactVu™ Micro-Ultrasound are highlighted innovations in their product lineup.

EDAP TMS has released positive results from the "HIFI" study involving 3,329 prostate cancer patients, demonstrating the efficacy of high-intensity focused ultrasound (HIFU) over radical prostatectomy (RP).

Notably, HIFU showed significantly better 24-month recurrence-free survival and superior urinary and erectile function, resulting in an enhanced quality of life. Conducted in 42 French hospitals, the study compares HIFU to traditional surgical methods, supporting the potential for HIFU to become a standard treatment option.

EDAP TMS SA (Nasdaq: EDAP) has reported significant progress in 2020, despite the challenges posed by the COVID-19 pandemic. The company secured a worldwide distribution agreement for Exact Imaging's micro ultrasound technologies, enhancing its Focal One® offerings. Key sales were made to renowned healthcare institutions, and a successful Phase 2 clinical trial for treating deep invasive rectal endometriosis was initiated. Importantly, US reimbursement rules for HIFU were established, increasing financial incentives for physicians. The company also expanded its market presence through a distribution agreement in Italy.

EDAP TMS SA (Nasdaq: EDAP) will participate in the 10th Annual LifeSci Partners Corporate Access Event from January 6-8 and 11-14, 2021. CEO Marc Oczachowski will host one-on-one meetings and present a corporate update on January 7, at 9 AM EST. Participants can register to listen to the presentation or request a meeting via the provided link. EDAP TMS is a leader in robotic energy-based therapies, developing medical devices for conditions such as prostate cancer and urinary tract stones.

EDAP TMS SA (Nasdaq: EDAP) has announced significant sales of its Focal One high intensity focused ultrasound (HIFU) technology to major U.S. healthcare institutions, including the University of California, San Francisco Medical Center and Cleveland Clinic. These transactions, completed in Q4, include a bundled sale with ExactVu technology. CEO Marc Oczachowski expressed optimism about the growing adoption of HIFU in prostate cancer management, emphasizing its non-invasive benefits. EDAP plans to provide further updates during its Q4 2020 conference call in March.

EDAP TMS SA announced that the U.S. Centers for Medicare and Medicaid Services (CMS) has established a Category 1 CPT code for reimbursement of High-Intensity Focused Ultrasound (HIFU) procedures for malignant prostate tissue, effective January 1, 2021. Physician reimbursement for HIFU will average $943, approximately 30% higher than for cryotherapy. Hospitals will receive around $4,500 per HIFU procedure, reflecting a 6% increase from 2020. This move is expected to drive adoption of EDAP's Focal One technology.

EDAP TMS SA (Nasdaq: EDAP) reported its strongest revenue quarter of 2020, with total revenue of EUR 9.4 million (USD 11.2 million), despite an 8.5% decrease year-over-year. Growth was noted in HIFU procedure revenues, complemented by significant sales to Mount Sinai Health System and USC. The company initiated a Phase 2 clinical trial for Focal One® targeting deep rectal endometriosis and ended the quarter with a strong cash position of EUR 19.9 million (USD 23.4 million). Caution was expressed regarding potential impacts on operations due to rising COVID-19 cases.

EDAP TMS SA announced an exclusive distribution agreement with AB Medica, enhancing the availability of its High Intensity Focused Ultrasound (HIFU) technology in Italy, one of Europe's largest medical device markets. This partnership complements AB Medica's existing portfolio, including robotic surgery solutions and ExactVu. The collaboration is expected to boost the adoption of EDAP's HIFU products in Italy, further establishing the company in the urology field.