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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) announces a partnership with Medical Technology Partners and Argenta Advisors to enhance market access for its Focal One high intensity focused ultrasound (HIFU) procedure. This collaboration aims to expand insurance coverage for Medicare and commercially insured patients following the establishment of a Category 1 CPT code effective January 1, 2021. The initiative is expected to increase the accessibility of Focal One HIFU in prostate cancer treatment, addressing significant unmet needs in the healthcare landscape.
EDAP TMS reported a record revenue of EUR 15.3 million ($18.3 million) for Q4 2020, a 28% increase from Q4 2019. This growth was fueled by a 50% rise in HIFU device sales, with eight devices sold during the quarter. Despite the ongoing COVID-19 pandemic, the company experienced sequential quarterly revenue growth throughout 2020. However, the total revenue for 2020 is projected at EUR 41.6 million ($47.8 million), a 7% decline compared to 2019 due to pandemic-related restrictions. The full-year results will be disclosed in March 2021.
EDAP TMS SA announced that Marc Oczachowski, President and CEO, will participate in a fireside chat at the B. Riley Securities Virtual Oncology Investor Conference on January 20, 2021, at 10:00 a.m. ET. An audio webcast will be available for replay on the EDAP investor website for 90 days. EDAP is recognized as a global leader in robotic energy-based therapies, focusing on minimally invasive medical devices for various conditions, including prostate cancer. The company’s Robotic HIFU devices and ExactVu™ Micro-Ultrasound are highlighted innovations in their product lineup.
EDAP TMS has released positive results from the "HIFI" study involving 3,329 prostate cancer patients, demonstrating the efficacy of high-intensity focused ultrasound (HIFU) over radical prostatectomy (RP).
Notably, HIFU showed significantly better 24-month recurrence-free survival and superior urinary and erectile function, resulting in an enhanced quality of life. Conducted in 42 French hospitals, the study compares HIFU to traditional surgical methods, supporting the potential for HIFU to become a standard treatment option.
EDAP TMS SA (Nasdaq: EDAP) has reported significant progress in 2020, despite the challenges posed by the COVID-19 pandemic. The company secured a worldwide distribution agreement for Exact Imaging's micro ultrasound technologies, enhancing its Focal One® offerings. Key sales were made to renowned healthcare institutions, and a successful Phase 2 clinical trial for treating deep invasive rectal endometriosis was initiated. Importantly, US reimbursement rules for HIFU were established, increasing financial incentives for physicians. The company also expanded its market presence through a distribution agreement in Italy.
EDAP TMS SA (Nasdaq: EDAP) will participate in the 10th Annual LifeSci Partners Corporate Access Event from January 6-8 and 11-14, 2021. CEO Marc Oczachowski will host one-on-one meetings and present a corporate update on January 7, at 9 AM EST. Participants can register to listen to the presentation or request a meeting via the provided link. EDAP TMS is a leader in robotic energy-based therapies, developing medical devices for conditions such as prostate cancer and urinary tract stones.
EDAP TMS SA (Nasdaq: EDAP) has announced significant sales of its Focal One high intensity focused ultrasound (HIFU) technology to major U.S. healthcare institutions, including the University of California, San Francisco Medical Center and Cleveland Clinic. These transactions, completed in Q4, include a bundled sale with ExactVu technology. CEO Marc Oczachowski expressed optimism about the growing adoption of HIFU in prostate cancer management, emphasizing its non-invasive benefits. EDAP plans to provide further updates during its Q4 2020 conference call in March.
EDAP TMS SA announced that the U.S. Centers for Medicare and Medicaid Services (CMS) has established a Category 1 CPT code for reimbursement of High-Intensity Focused Ultrasound (HIFU) procedures for malignant prostate tissue, effective January 1, 2021. Physician reimbursement for HIFU will average $943, approximately 30% higher than for cryotherapy. Hospitals will receive around $4,500 per HIFU procedure, reflecting a 6% increase from 2020. This move is expected to drive adoption of EDAP's Focal One technology.
EDAP TMS SA (Nasdaq: EDAP) reported its strongest revenue quarter of 2020, with total revenue of EUR 9.4 million (USD 11.2 million), despite an 8.5% decrease year-over-year. Growth was noted in HIFU procedure revenues, complemented by significant sales to Mount Sinai Health System and USC. The company initiated a Phase 2 clinical trial for Focal One® targeting deep rectal endometriosis and ended the quarter with a strong cash position of EUR 19.9 million (USD 23.4 million). Caution was expressed regarding potential impacts on operations due to rising COVID-19 cases.
EDAP TMS SA announced an exclusive distribution agreement with AB Medica, enhancing the availability of its High Intensity Focused Ultrasound (HIFU) technology in Italy, one of Europe's largest medical device markets. This partnership complements AB Medica's existing portfolio, including robotic surgery solutions and ExactVu. The collaboration is expected to boost the adoption of EDAP's HIFU products in Italy, further establishing the company in the urology field.
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