Welcome to our dedicated page for Edap Tms news (Ticker: EDAP), a resource for investors and traders seeking the latest updates and insights on Edap Tms stock.
EDAP TMS SA (Nasdaq: EDAP) is described in its filings and press releases as a global leader in robotic energy-based therapies, focused on High-Intensity Focused Ultrasound (HIFU) and related ultrasound-based medical devices. The EDAP news feed on Stock Titan aggregates company announcements, financial updates and regulatory disclosures so readers can follow developments around its Focal One Robotic HIFU platform and broader therapeutic ultrasound portfolio.
Recent news from EDAP highlights HIFU revenue growth, system placements and procedure volumes, as well as guidance on expected revenue trends in its core HIFU business and non-core ESWL and Distribution segments. The company regularly reports unaudited quarterly financial results via Form 6-K, including details on sales of medical equipment, recurring revenue programs, and spare parts and services, along with commentary on gross margins and operating performance.
Investors and healthcare observers can also use the news stream to track regulatory milestones and clinical adoption. EDAP has announced FDA 510(k) clearance for new ultrasound imaging and workflow enhancements to the Focal One HIFU system, as well as reimbursement in France for Focal One Robotic HIFU procedures in prostate cancer under the national universal health system. News items further cover recognition such as an Industry Award for Innovations in Endourological Instrumentation for the Focal One platform.
Other news categories include financing and capital structure updates, such as a multi-tranche credit facility with the European Investment Bank intended to support expansion of the Focal One platform, and information about EDAP’s transition from foreign private issuer to U.S. domestic filer status. Coverage of conference presentations and investor meetings provides additional context on how management presents the company’s strategy in urology, prostate cancer and benign disease markets.
By reviewing the EDAP news page, readers can follow company-reported trends in HIFU adoption, reimbursement developments, clinical evidence references and financial guidance, all drawn from EDAP’s own press releases and SEC-reported materials.
EDAP TMS SA reported strong fourth quarter 2020 results with revenue of EUR 15.4 million (USD 18.3 million), a 28% increase year-over-year. The company's HIFU revenue surged by 51%, driven by increased demand for its Focal One system and partnerships with notable healthcare institutions like UCSF and Cleveland Clinic. Despite an overall revenue decline of 7% for the full year 2020 due to COVID-19, EDAP maintained profitability with a cash position of EUR 24.7 million (USD 30.2 million). The company continues to focus on expanding its market presence in robotic energy-based therapies.
EDAP TMS SA (Nasdaq: EDAP) will release its financial results for the fourth quarter and year ended December 31, 2020 on March 30, 2021, after market close. A conference call led by CEO Marc Oczachowski and CFO François Dietsch is scheduled for March 31, 2021, at 8:30 AM EDT. The call will discuss key financial metrics and developments related to the company’s innovative medical devices, enhancing its position in therapeutic ultrasound.
EDAP TMS SA (Nasdaq: EDAP) announces a partnership with Medical Technology Partners and Argenta Advisors to enhance market access for its Focal One high intensity focused ultrasound (HIFU) procedure. This collaboration aims to expand insurance coverage for Medicare and commercially insured patients following the establishment of a Category 1 CPT code effective January 1, 2021. The initiative is expected to increase the accessibility of Focal One HIFU in prostate cancer treatment, addressing significant unmet needs in the healthcare landscape.
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.
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