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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 SA (Nasdaq: EDAP) has reported a strong financial performance for the second quarter of 2022, achieving approximately EUR 14.2 million (USD 15.0 million) in revenue, marking a 36.7% increase year-over-year. The company experienced a 79% growth in HIFU revenues compared to the same period in 2021. Notably, the Centers for Medicare and Medicaid Services proposed raising the Focal One HIFU reimbursement to APC Level 6, which is expected to significantly enhance patient access. As of June 30, 2022, EDAP held cash reserves of EUR 46.3 million (USD 48.5 million).
EDAP TMS SA (Nasdaq: EDAP) will announce its Q2 2022 financial results on August 24, 2022, after market close. A conference call and webcast will follow on August 25 at 8:30 am EDT, featuring key executives including Marc Oczachowski, Ryan Rhodes, and François Dietsch. EDAP TMS is recognized for its advancements in robotic energy-based therapies and ultrasound technology for medical devices, particularly in prostate cancer treatment.
EDAP TMS SA (Nasdaq: EDAP) announced that the proposed outpatient payment rule by CMS for CY23 would increase Medicare reimbursement for the Focal One HIFU procedure from $4,506 to $8,711 per case. This change reflects the procedure's value compared to more invasive treatments and is expected to enhance patient access to focal HIFU. With comments due by September 30 and a final rule expected in November, the new rates will take effect on January 1, 2023. This increase may influence commercial payors and improve overall market acceptance for EDAP's HIFU devices.
EDAP TMS SA (Nasdaq: EDAP) announced its participation in two significant urology congresses: the EAU Congress in Amsterdam from July 1-4, 2022, and the SRS Congress in Orlando from June 30 to July 3, 2022. At these events, EDAP will showcase its Focal One® Robotic Focal HIFU technology, emphasizing its role in prostate cancer treatment. Key presentations will include a randomized trial comparing ExactVu micro-ultrasound with MRI and discussions on the growing adoption of Focal One as a minimally invasive therapy. This involvement is expected to enhance EDAP's visibility and customer engagement in the urology space.
EDAP TMS SA (Nasdaq: EDAP), a leader in robotic energy-based therapies, announced that Prof. Gil Dubernard will present at the 6th European Endometriosis Congress in Bordeaux, France, on June 17. The presentation will focus on the potential of High Intensity Focused Ultrasound (HIFU) as a treatment for symptomatic rectal endometriosis. CEO Marc Oczachowski emphasized the importance of this research, which suggests that HIFU may provide a less invasive option for patients suffering from endometriosis.
EDAP TMS SA (Nasdaq: EDAP) announced three significant presentations on its high intensity focused ultrasound (HIFU) technology at the 21st Annual International Symposium on Therapeutic Ultrasound (ISTU) from June 7-10, 2022, in Toronto. Topics include the efficacy of TR-HIFU in treating rectal endometriosis, monitoring techniques for HIFU lesions in prostate cancer, and a preclinical evaluation of a dual-mode ultrasound-guided HIFU probe. The findings suggest potential advancements in minimally invasive treatments and enhance EDAP's position in the therapeutic ultrasound market.
EDAP TMS SA reported first quarter 2022 revenue of approximately EUR 13.0 million (USD 14.5 million), reflecting a 26% increase year-over-year. The company sold four Focal One units in Q1 2022, compared to none in Q1 2021. Total revenue from the HIFU business was EUR 3.8 million (USD 4.3 million), significantly up from EUR 1.8 million (USD 2.2 million). However, LITHO business revenue declined to EUR 2.2 million (USD 2.5 million). Gross profit improved to EUR 5.8 million (USD 6.4 million), with a gross margin of 44.3%. As of March 31, 2022, cash reserves were EUR 46.5 million (USD 51.6 million).
EDAP TMS SA (Nasdaq: EDAP) will announce its Q1 2022 financial results on May 17, 2022, after market close. A conference call will take place on May 18, 2022, at 8:30 am EDT, featuring key executives including Marc Oczachowski and Ryan Rhodes. This event will provide insights into the company's performance in the therapeutic ultrasound market, where it leads in minimally invasive medical devices for prostate treatment.
More information and registration details are available through the webcast link.
EDAP TMS SA (Nasdaq: EDAP) will showcase its Focal One® Robotic HIFU platform at the AUA annual meeting from May 13-15 in New Orleans, highlighting its role in prostate cancer treatment. The event will include presentations by leading academic centers on the clinical acceptance of focal therapy. Ryan Rhodes, CEO of EDAP U.S., expressed confidence in Focal One® as advanced technology. Attendees will also experience hands-on training with Focal One® and ExactVu™ Micro-Ultrasound at the EDAP booth, demonstrating its complete solution for prostate cancer diagnostics and treatment.
EDAP TMS SA (Nasdaq: EDAP) announced the placement of three Focal One® machines in prestigious U.S. academic centers during Q1 2022, signaling a strong demand for robotic focal therapy. The placements include New York-Presbyterian/Weill Cornell, Beth Israel Deaconess Lahey Health, and UC Davis Medical Center, the latter marking its fourth installation in the University of California Health System. Additionally, five ExactVu micro-ultrasound systems were sold. The company plans to report full financial results for Q1 2022 in mid-May, highlighting ongoing momentum in prostate cancer treatment technologies.
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