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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 a revenue increase of 22.5% for the first half of 2021, totaling EUR 20.7 million (USD 24.8 million). Despite strong growth in U.S. HIFU treatment volumes, the HIFU business revenue declined by 15.1% year-over-year. Net income improved to EUR 0.4 million (USD 0.4 million), compared to a net loss of EUR 1.5 million in the prior year. The CMS advisory panel recommended increasing HIFU reimbursement rates significantly for 2022, which could boost future sales. The company maintained a robust cash balance of EUR 45 million (USD 53.3 million) as of June 30, 2021.
EDAP TMS SA (Nasdaq: EDAP) reported preliminary second quarter 2021 revenue of approximately EUR 10.4 million (USD $12.4 million), an 11.8% increase year-over-year, with first half revenue rising 22.5% to EUR 20.7 million (USD $24.8 million). U.S. High-Intensity Focused Ultrasound (HIFU) treatment volumes surged 79% compared to 2020, signaling strong adoption in the market. The company ended the quarter with cash and cash equivalents of EUR 45 million (USD $53.3 million) and announced the appointment of Ryan Rhodes as CEO of its U.S. subsidiary. A detailed financial report is expected on August 25, 2021.
EDAP TMS SA (Nasdaq: EDAP) announces significant achievements in 2021, including a successful secondary offering that raised approximately $28 million to enhance its U.S. market capabilities. The company has made notable sales to prominent health institutions like Mt. Sinai and Cleveland Clinic. The hiring of Ryan Rhodes as CEO of the U.S. subsidiary aims to accelerate high intensity focused ultrasound (HIFU) adoption in prostate cancer treatment. Additionally, a Category 1 CPT code was established for HIFU reimbursement, effective January 1, 2021.
EDAP TMS SA appointed Ryan Rhodes as CEO of its U.S. subsidiary, aiming to boost U.S. expansion. Rhodes brings 14 years of experience from Intuitive Surgical, where he advanced robotic surgery globally. His leadership is expected to drive the adoption of EDAP's Focal One technology for prostate cancer treatment, leveraging recent reimbursement coverage and clinical evidence. Chairman Marc Oczachowski emphasized the need for innovative therapies to improve cancer care standards, with Rhodes expressing optimism about future growth opportunities.
EDAP TMS SA reported a strong first quarter of 2021, generating revenues of EUR 10.3 million (USD 12.4 million), a 35.4% increase year-over-year. The company achieved a gross margin of 42.4% and reported a net income of EUR 0.8 million (USD 0.9 million). The revenue from the Distribution business doubled, reaching EUR 5.6 million (USD 6.7 million). Despite a 6.2% decline in HIFU revenue, EDAP maintains a strong cash position of EUR 24.4 million (USD 28.6 million) as of March 31, 2021, bolstered by a recent $28 million public offering.
EDAP TMS SA (Nasdaq: EDAP) will release its first-quarter financial results for the period ending March 31, 2021, on May 11, 2021, after market close. A conference call and webcast will follow on May 12, 2021, at 8:30 am EDT, featuring remarks from Marc Oczachowski, CEO, and François Dietsch, CFO. EDAP TMS is a leader in robotic energy-based therapies and develops innovative medical devices for prostate cancer treatment. The company aims to provide comprehensive solutions from diagnosis to treatment within the therapeutic ultrasound market.
EDAP TMS S.A. (NASDAQ: EDAP) announced an offering of American Depositary Shares (ADS) at $6.75 per share, totaling 4,150,000 ADSs for approximately $28 million. The offering is expected to close on April 27, 2021, pending customary conditions. Piper Sandler is the sole book-running manager, while B. Riley Securities and Lake Street Capital Markets serve as co-managers. The offering is registered with the SEC, and a prospectus supplement will be filed. This press release does not constitute an offer to sell or solicit offers to buy these securities in any jurisdiction where such actions would be unlawful.
EDAP TMS S.A. announced a follow-on public offering of its American Depositary Shares (ADSs), each representing one ordinary share. The offering is managed by Piper Sandler, with a shelf registration filed with the SEC. The company estimates total revenues between €10.0 million and €10.4 million for Q1 2021, up from €7.6 million in the same quarter of 2020. Gross margin is expected between 40% and 44%, and cash and cash equivalents stand at approximately €24.4 million. This press release cautions investors about reliance on preliminary estimates and market risks.
EDAP TMS SA reported strong fourth quarter 2020 results with revenue of EUR 15.4 million (USD 18.3 million), a 28% increase year-over-year. The company's HIFU revenue surged by 51%, driven by increased demand for its Focal One system and partnerships with notable healthcare institutions like UCSF and Cleveland Clinic. Despite an overall revenue decline of 7% for the full year 2020 due to COVID-19, EDAP maintained profitability with a cash position of EUR 24.7 million (USD 30.2 million). The company continues to focus on expanding its market presence in robotic energy-based therapies.
EDAP TMS SA (Nasdaq: EDAP) will release its financial results for the fourth quarter and year ended December 31, 2020 on March 30, 2021, after market close. A conference call led by CEO Marc Oczachowski and CFO François Dietsch is scheduled for March 31, 2021, at 8:30 AM EDT. The call will discuss key financial metrics and developments related to the company’s innovative medical devices, enhancing its position in therapeutic ultrasound.
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