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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 reported robust growth in Q1 2024 with a significant 92% increase in U.S. Focal One® HIFU procedures year-over-year. HIFU revenue rose 10.2% to EUR 5.8 million ($6.3 million), contributing to a total revenue of EUR 14.9 million ($16.1 million), up 0.8% from Q1 2023. Gross profit increased to EUR 6.4 million ($6.9 million), driven by higher treatment revenues. Operating expenses dropped to EUR 11.2 million ($12.1 million) due to a non-recurring compensation expense in Q1 2023. Despite an operating loss of EUR 4.8 million ($5.2 million), net loss improved to EUR 4.5 million ($4.9 million) from EUR 7.5 million ($8.1 million) in Q1 2023. Additionally, EDAP's Phase 3 study on endometriosis is expected to yield results in the latter half of 2024.
EDAP TMS SA announced positive final results from the HIFI Study comparing Focal One® HIFU versus radical prostatectomy at the 119th AUA Annual Meeting. The study showed a higher salvage treatment free survival rate in the HIFU arm, better urinary continence and erectile function outcomes, and demonstrated the effectiveness and safety of robotic HIFU in managing localized prostate cancer. The study enrolled a total of 3,328 patients across 46 centers, highlighting the growing relevance of robotic HIFU in prostate cancer management.
EDAP TMS SA, a global leader in robotic energy-based therapies, will announce its first quarter 2024 financial results on May 16, 2024. The company will host a conference call and webcast with key executives to discuss the results. Investors can join the call to learn more about the financial performance and strategic direction of EDAP.
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