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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 reported strong performance for its Focal One HIFU technology in Q4 2022, placing nine machines in the U.S., including seven sales. The placements were made across both academic medical centers and community hospitals. CEO Marc Oczachowski emphasized the momentum in the market, while Ryan Rhodes highlighted the increasing awareness of Focal One as a viable treatment for prostate cancer. EDAP TMS aims to build on this success throughout 2023.
EDAP TMS SA has appointed Ken Mobeck as Chief Financial Officer for its U.S. subsidiary, EDAP Technomed Inc. With over 25 years of experience in finance, he previously held significant roles at Accuray and Lumentum, enhancing operational performance and driving revenue growth. This strategic hire aims to bolster the company's leadership team and support the expansion of the Focal One® Robotic HIFU platform in the U.S. market, which is critical for EDAP's growth trajectory.
EDAP TMS SA (Nasdaq: EDAP) has received approval to start a Phase 3 clinical trial for Focal One high intensity focused ultrasound (HIFU) targeting rectal deep infiltrating endometriosis. The trial, beginning in Q2 2023, will enroll 60 subjects across eight centers in France, assessing acute pelvic pain three months post-treatment. This initiative follows a completed Phase 2 study, with results expected to be presented in early 2023. The CEO emphasized the significance of this trial in building clinical evidence for HIFU as a treatment for this debilitating condition.
EDAP reported strong Q3 2022 results with total revenue of approximately EUR 12.2 million (USD 12.3 million), a 29.7% increase from EUR 9.4 million (USD 11.1 million) in Q3 2021. Year-to-date revenue rose 30.9% to EUR 39.4 million (USD 41.7 million). HIFU sales surged 81% year-over-year, contributing EUR 3.5 million (USD 3.5 million) in Q3. The company ended the quarter with a cash position of EUR 68.3 million (USD 66.8 million).
The U.S. CMS increased reimbursement for HIFU prostate ablation, boosting potential hospital revenue by over 90%.
EDAP TMS SA (Nasdaq: EDAP) will release its third-quarter financial results for the period ending September 30, 2022, on November 16, 2022, after market close. A conference call will follow on November 17, 2022, at 8:30 AM EDT, featuring key executives including Marc Oczachowski, Ryan Rhodes, and François Dietsch. The company is recognized for its innovations in robotic energy-based therapies, particularly in the ultrasound market, offering products such as Focal One® and ExactVu™ for prostate cancer treatment.
EDAP TMS SA announced a significant increase in Medicare reimbursement for the Focal One HIFU prostate ablation procedure, effective January 1, 2023. The reimbursement will rise to $8,558 per procedure, a 90% increase from the current $4,506. This adjustment reflects CMS's recognition of the value of HIFU therapy, potentially expanding access to patients and influencing commercial payors. The management views this as a crucial step for prostate cancer treatment and plans to discuss its impact during the upcoming Q3 2022 results conference call.
EDAP TMS SA (Nasdaq: EDAP) will host a urology expert panel and live demonstration of its Focal One® technology on September 29, 2022, at 8 AM ET at the Langham Hotel in New York City. The event will feature presentations from the U.S. CEO and leading prostate cancer experts, followed by a live Q&A session. EDAP TMS is recognized for its advancements in robotic therapeutic ultrasound and offers a comprehensive solution for prostate cancer treatment. The company aims to enhance market acceptance of its HIFU devices amidst ongoing challenges from the COVID-19 pandemic.
EDAP TMS S.A. announced a public offering of 2,666,667 American Depositary Shares (ADSs) priced at $7.50 each on September 22, 2022. The offering aims to raise approximately $20 million before expenses. Jefferies LLC will act as the sole book-running manager and has a 30-day option to purchase an additional 400,000 ADSs. The offering's closing is anticipated on September 27, 2022, subject to customary conditions. The initial registration statement for this offering was filed with the SEC in April 2021.
EDAP TMS announced a public offering of its American Depositary Shares (ADSs) on September 22, 2022, with Jefferies LLC as the sole book-running manager. The offering's completion and terms are subject to market conditions, and there are no assurances regarding these aspects. A shelf registration statement effective since April 7, 2021, is in place for the offering. Investors are advised to review the preliminary prospectus supplement and associated documents before purchasing. The offering will not take place in Europe, and forward-looking statements are subject to various uncertainties.
EDAP TMS SA (Nasdaq: EDAP) has reported a strong financial performance for the second quarter of 2022, achieving approximately EUR 14.2 million (USD 15.0 million) in revenue, marking a 36.7% increase year-over-year. The company experienced a 79% growth in HIFU revenues compared to the same period in 2021. Notably, the Centers for Medicare and Medicaid Services proposed raising the Focal One HIFU reimbursement to APC Level 6, which is expected to significantly enhance patient access. As of June 30, 2022, EDAP held cash reserves of EUR 46.3 million (USD 48.5 million).
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