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Edap Tms - EDAP STOCK NEWS

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Company Overview

EDAP TMS SA (NASDAQ: EDAP) is a seasoned global entity focused on the development, manufacturing, promotion, and distribution of minimally-invasive medical devices utilizing advanced therapeutic ultrasound and high-intensity focused ultrasound (HIFU) technologies. With more than three decades of operational history, the company has forged a deep expertise in urological therapies, addressing critical challenges in localized prostate cancer treatment and other urological disorders through innovative, robotic energy-based therapeutic systems.

Innovative Medical Technologies

At its core, EDAP TMS harnesses the potential of therapeutic ultrasound and HIFU to provide patients with precise, minimally-invasive treatment options. The company is architected on a robust portfolio of innovative technologies, backed by a significant patent collection that underscores its commitment to research and development. By integrating advanced imaging with refined treatment modalities, EDAP TMS has set a benchmark in the field of non-surgical therapeutic interventions.

Divisional Expertise and Offerings

EDAP TMS operates through three distinct divisions, each addressing a critical component of the medical device market:

  • HIFU Division: Specializes in developing, manufacturing, and marketing devices that utilize HIFU technology to target and ablate tumors. This division includes a comprehensive range of robotic therapeutic devices that facilitate both invasive and focal treatment options.
  • ESWL Division: Focuses on the engineering and servicing of extracorporeal shockwave lithotripsy systems, providing effective treatment solutions for patients with kidney stones and other related conditions.
  • Distribution Division: Complements the in-house offerings by marketing third-party medical products such as lasers and micro-ultrasound systems, thereby broadening the overall market reach of the company.

Global Market Presence

EDAP TMS has established an extensive global network, operating through corporate offices, subsidiaries, and strategic distribution partnerships across Asia, France, the United States, and other international markets. This diversified geographical reach not only supports robust market penetration but also fosters collaborative clinical research and sharing of best practices in medical device technologies.

Research & Development and Industry Collaborations

The company continually invests in R&D, leveraging partnerships with internationally renowned medical research institutions to drive innovation. This proactive approach has led to the development of its cutting-edge robotic HIFU platforms, including widely recognized solutions for ablation and focal therapy. The integration of imaging advancements with HIFU technology addresses critical needs in minimally-invasive therapies, ensuring that the company's offerings remain at the forefront of medical innovation.

Market Position and Competitive Landscape

EDAP TMS stands out in an increasingly competitive market not only due to its technological prowess but also because of its commitment to quality and regulatory excellence. The clinical credibility embedded in its products is evidenced by rigorous academic collaborations and the publication of peer-reviewed clinical data in prestigious medical journals. While operating within a challenging and tightly regulated industry, the company’s diverse product portfolio and technological innovation serve as key competitive differentiators. Its approach of combining reliable treatment solutions with focused therapy for conditions such as localized prostate cancer provides a solid foundation that appeals to healthcare professionals globally.

Commitment to Quality and Expertise

The operational excellence of EDAP TMS is demonstrated through a disciplined focus on research, development, and quality assurance. The company’s technological infrastructure is built on precision and reliability, ensuring that every device meets the stringent requirements of modern medical practice. Its integrated approach, which connects clinical research with robust manufacturing and distribution strategies, underscores a deep industry expertise that retains credibility across its multiple market segments.

In Summary

Through its pioneering initiatives in robotic and minimally-invasive therapeutic solutions, EDAP TMS SA has cemented its position as a major actor in the field of therapeutic ultrasound and HIFU technology. The company's multi-divisional structure, global outreach, and relentless pursuit of innovation provide an in-depth understanding of the evolving landscape of urological treatment options, contributing to its sustainable role in the medical devices industry.

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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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EDAP TMS SA (Nasdaq: EDAP) Announces CEO's Participation at Piper Sandler 35th Annual Healthcare Conference in New York, New York
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FAQ

What is the current stock price of Edap Tms (EDAP)?

The current stock price of Edap Tms (EDAP) is $1.91 as of April 3, 2025.

What is the market cap of Edap Tms (EDAP)?

The market cap of Edap Tms (EDAP) is approximately 72.0M.

What is the core business of EDAP TMS?

EDAP TMS develops, manufactures, promotes, and distributes minimally-invasive medical devices using advanced therapeutic ultrasound and HIFU technology, primarily for urological treatments.

How does EDAP TMS generate revenue?

The company earns revenue through its three operating divisions: HIFU devices for tumor and prostate therapies, ESWL systems for lithotripsy, and the distribution of complementary third-party medical products.

What makes EDAP TMS' HIFU technology unique?

Its HIFU technology is distinguished by the integration of advanced imaging and robotics, offering precision in ablative and focal therapies while maintaining a robust patent portfolio supported by extensive R&D.

In which geographical regions does EDAP TMS operate?

EDAP TMS has a broad international presence with core markets in Asia, France, the United States, and several other global regions, supported by a vast network of corporate offices and distributors.

How does the company support its innovation process?

Continuous investment in R&D, along with strategic collaborations with leading international medical research institutions, defines EDAP TMS' commitment to technological advancement and quality improvement.

What are the main product segments of EDAP TMS?

The company is organized into three divisions: the HIFU division for tumor ablation devices, the ESWL division for lithotripsy systems, and the Distribution division for additional medical products like lasers and micro-ultrasound systems.

How does EDAP TMS ensure the quality and reliability of its devices?

EDAP TMS integrates rigorous quality assurance processes, advanced engineering, and sustained R&D efforts to design devices that meet high industry standards and regulatory requirements.

How does EDAP TMS compare with its competitors in the medical devices industry?

By concentrating on advanced therapeutic ultrasound and HIFU technologies, combined with a diversified product portfolio and strong clinical partnerships, EDAP TMS maintains a distinct position within a competitive landscape.
Edap Tms

Nasdaq:EDAP

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71.98M
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41.47%
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