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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) 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.
EDAP TMS SA reported unaudited financial results for 2021, achieving total revenue of EUR 44.1 million (USD 51.9 million), a 5.8% increase from 2020. Notably, US HIFU treatment volumes surged by 65%, reflecting higher adoption rates among urologists. However, the HIFU segment saw a revenue decline to EUR 9.9 million (USD 11.7 million) from EUR 11.4 million (USD 13.1 million) in 2020. Operating loss reached EUR 1.6 million (USD 1.9 million), contrasting with a profit in 2020. The company ended the year with a strong cash position of EUR 47.2 million (USD 53.4 million).
EDAP TMS SA will release its financial results for Q4 2021 on March 30, 2022, after market close. The company will host a conference call on March 31, 2022, at 8:30 am ET, featuring key executives including CEO Marc Oczachowski and CFO François Dietsch. EDAP is a leader in therapeutic ultrasound, offering products such as the Focal One® and ExactVu™ for prostate cancer treatment. The call will provide insights into the company's performance and future outlook, key points for investors to consider.
EDAP TMS SA, a leader in robotic energy-based therapies, reported a remarkable 65% increase in U.S. HIFU treatment volumes for 2021, indicating strong adoption of their Focal One technology despite pandemic challenges. The company expanded its U.S. presence, placing Focal One devices in prestigious hospitals. Additionally, progress was made in R&D, particularly in evaluating HIFU for treating rectal endometriosis and pancreatic cancer. With a solid cash position and successful fourth-quarter momentum, EDAP anticipates a productive 2022, aiming to capitalize on their growth strategy.
EDAP TMS has published promising pre-clinical results in the peer-reviewed journal Cancers, showcasing the potential of high intensity focused ultrasound (HIFU) for treating locally advanced pancreatic cancer. The study found that HIFU can induce irreversible tissue necrosis rapidly, highlighting its feasibility under Doppler guidance. This research paves the way for a forthcoming Phase I clinical study, aiming to evaluate the safety and efficacy of HIFU in patients with this challenging cancer type. The overall 5-year survival rate for patients with locally advanced pancreatic adenocarcinoma is under 5%, underscoring the need for innovative treatment options.
EDAP TMS announced notable growth for its Focal One device in the U.S., with installations at five leading healthcare centers, including Brigham and Women’s Hospital and Cedars-Sinai, during Q4 2021.
CEO Marc Oczachowski expressed optimism regarding increased market adoption following a restructuring of U.S. operations.
Ryan Rhodes, CEO of EDAP U.S., highlighted the device's significance in prostate oncology as they enter 2022 with strong momentum.
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