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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.
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EDAP TMS SA (Nasdaq: EDAP) will release its financial results for Q4 and full-year 2023 on March 27, 2024. The company, a leader in robotic energy-based therapies, will host a conference call and webcast with top executives. Details for participation are provided.
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EDAP TMS SA CEO to Present at Oppenheimer Healthcare MedTech & Services Conference
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EDAP TMS SA's Focal One platform, granted Breakthrough Device designation by the FDA, aims to address deep infiltrating endometriosis, a significant unmet medical need in women's health. Positive Phase 2 study results show a decrease in symptoms and improvement in quality of life, supporting the safety and efficacy of the Focal One HIFU therapy. The ongoing Phase 3 study is expected to provide further insights into the treatment's effectiveness.
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EDAP TMS SA reports record full-year 2023 revenue of EUR 60.4 million, driven by 31.7% HIFU growth, with a strong Q4 revenue of EUR 19.6 million and 136% U.S. Focal One HIFU procedure growth. CEO Ryan Rhodes highlights increased demand and business momentum for Focal One Robotic HIFU in prostate cancer management.
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EDAP TMS SA has completed enrollment in its Phase 3 study evaluating Focal One High-Intensity Focused Ultrasound (HIFU) therapy for the treatment of deep infiltrating rectal endometriosis. The study, which included a sham-controlled arm, is expected to yield results in the second half of 2024. Positive results from the Phase 2 study showed a significant decrease in symptoms and improved quality of life for patients.
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EDAP TMS SA (Nasdaq: EDAP) reports preliminary placement results of twelve Focal One Systems, inclusive of ten capital sales. The company experienced robust demand for its Focal One robotic HIFU technology and had a record quarter for sales of ExactVu™ Micro-Ultrasound systems used for prostate biopsy. The placements show strong interest among both academic medical centers and community hospitals. The CEO, Ryan Rhodes, expressed confidence in Focal One becoming a necessary solution in the management of prostate cancer.
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EDAP TMS SA (Nasdaq: EDAP) appoints new Chief Financial Officer and Global Chief Accounting Officer to support strategic growth initiatives in the U.S.
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EDAP TMS SA (Nasdaq: EDAP) receives a favorable recommendation from the French National Authority for Health for the reimbursement of high-intensity focused ultrasound (HIFU) therapy in the treatment of prostate cancer, marking a significant milestone in securing final reimbursement in France. The positive opinion is based on the outstanding safety and favorable clinical outcomes from the Focal One Robotic HIFU in the HIFI study, which included more than 3,000 prostate cancer patients. This decision brings the company closer to expanding treatment options for physicians and their patients with the leading Focal One HIFU technology platform.
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EDAP TMS SA (Nasdaq: EDAP) announced the appointment of Dr. Lance Willsey, M.S., M.D. to its Board of Directors, replacing Dr. Argil Wheelock. Dr. Willsey, a trained urologist with 36 years of experience in cancer diagnostics and therapeutics, expressed his excitement to contribute to the company’s development and shareholder value. The Chairman of the Board, Marc Oczachowski, welcomed Dr. Willsey and thanked Dr. Wheelock for his significant contribution during his almost 15-year tenure.
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EDAP TMS SA (Nasdaq: EDAP) has received the Industry Category Award from the French National Institute for Intellectual Property (INPI) for its innovative therapeutic ultrasound technology. The award recognizes EDAP's strategic priority of securing critical IP protections to help commercialize therapeutic ultrasound technology globally. The company's robotic ultrasound platform, Focal One®, is a non-invasive, incision-free treatment for localized prostate cancer, with potential applications for other targeted pathologies such as deep rectal endometriosis.
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FAQ
What is the current stock price of EDAP TMS SA (EDAP)?
The current stock price of EDAP TMS SA (EDAP) is $2.47 as of November 22, 2024.
What is the market cap of EDAP TMS SA (EDAP)?
The market cap of EDAP TMS SA (EDAP) is approximately 94.8M.
What does EDAP TMS SA specialize in?
EDAP TMS SA specializes in developing, manufacturing, and distributing minimally-invasive medical devices for urology using advanced ultrasound technology.
What are the main divisions of EDAP TMS SA?
The main divisions are HIFU (High-Intensity Focused Ultrasound), ESWL (Extracorporeal ShockWave Lithotripsy), and Distribution.
What products are included in the HIFU division?
The HIFU division includes products like Ablatherm, Ablatherm Fusion, and the Focal One for non-invasive tumor destruction.
What is the function of the ESWL division?
The ESWL division focuses on the manufacturing and servicing of the Sonolith range of lithotripters used for kidney stone treatment.
What type of products does the Distribution division market?
The Distribution division markets complementary medical products such as lasers, micro-ultrasound systems, and other third-party medical devices.
What recent achievements has EDAP TMS SA accomplished?
Recent achievements include the introduction of the Focal One for focal therapy of localized prostate cancer and strategic partnerships to enhance product reach.
How does EDAP TMS SA support its innovation?
EDAP TMS SA supports innovation through continuous investment in research and development and partnerships with internationally renowned medical research institutions.
What were the financial results for EDAP TMS SA in 2023?
In 2023, EDAP TMS SA reported a gross profit of EUR 24.4 million (USD 26.4 million), with a gross profit margin of 40.4%.
How does EDAP TMS SA maintain its market position?
The company maintains its market position by continuously innovating, expanding its patent portfolio, and forming strategic partnerships.
Who can be contacted for investor relations at EDAP TMS SA?
For investor relations, you can contact Blandine Confort at bconfort@edap-tms.com or John Fraunces at jfraunces@lifesciadvisors.com.
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