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EDAP TMS SA (NASDAQ: EDAP) is a global leader in therapeutic ultrasound with over 30 years of experience. The company develops, manufactures, promotes, and distributes minimally-invasive medical devices for urology using advanced ultrasound technology. With a robust presence worldwide through a network of corporate offices, subsidiaries, and distribution partners, EDAP TMS is committed to innovation and excellence.
EDAP TMS operates through three main divisions:
- HIFU (High-Intensity Focused Ultrasound): This division focuses on the development and marketing of devices for the non-invasive destruction of tumors. Key products include Ablatherm, Ablatherm Fusion, and the Focal One, which is the latest addition designed for ideal focal therapy of localized prostate cancer.
- ESWL (Extracorporeal ShockWave Lithotripsy): This division manufactures and services the Sonolith range of lithotripters, which are used for the treatment of kidney stones.
- Distribution: This division markets complementary products such as lasers, micro-ultrasound systems, and other medical devices from third-party suppliers.
EDAP TMS is known for its strong patent portfolio thanks to continuous investment in research and development. The company collaborates with globally acclaimed medical research institutions to push the boundaries of medical technology. Financially, EDAP TMS reported a gross profit of EUR 24.4 million (USD 26.4 million) for the year ending December 31, 2023, reflecting a slight increase from the previous year. However, the gross profit margin declined due to inflationary pressures and investments in U.S. operations to support long-term revenue growth.
Recent achievements include the launch of the Focal One and strategic partnerships to expand its product reach. The company’s commitment to innovation and patient care makes it a significant player in the medical device industry.
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.
EDAP TMS SA (Nasdaq: EDAP), a leader in robotic energy-based therapies, announced its participation in the Jefferies Virtual London Healthcare Conference from November 17-19, 2020. The presentation is scheduled for November 17 at 10:00 am BT. A webcast of the event will be available for replay for 90 days. EDAP focuses on minimally invasive medical devices, including its Focal One® for prostate ablation and ExactVu™ Micro-Ultrasound. Potential risks include market acceptance of its HIFU devices and impacts from COVID-19 on demand.
EDAP TMS SA (Nasdaq: EDAP), a leader in therapeutic ultrasound, will release its third-quarter financial results for 2020 after market close on November 18, 2020. A conference call, led by CEO Marc Oczachowski and CFO François Dietsch, is scheduled for November 19, 2020, at 8:30 AM EDT. This event will allow investors and stakeholders to discuss the results and future outlook. EDAP TMS is recognized for its minimally invasive ultrasound medical devices, including the Focal One® and ExactVu™ systems for prostate treatment.
EDAP TMS SA (Nasdaq: EDAP) will host a Key Opinion Leader call on September 22, 2020, at 8am ET to discuss its commercial products, Focal One® and ExactVu™. The call features Dr. Brian Miles and Dr. Laurence Klotz, who will explore the potential of Focal One® High Intensity Focused Ultrasound (HIFU) and ExactVu™ micro-ultrasound. Management will also update on sales achievements and pipeline expansion opportunities beyond prostate cancer.
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