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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.
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.
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).
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