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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 reported record financial results for Q4 and full-year 2024, with notable growth in its HIFU business segment. The company achieved record full-year HIFU revenue of USD 25.7 million, up 15.3% from 2023, and Q4 HIFU revenue of USD 9.3 million, a 15% increase year-over-year.
Key highlights include a 51% growth in U.S. Focal One HIFU procedures in 2024, CE Mark approval for deep infiltrating endometriosis treatment, and positive outcomes from the HIFI study comparing Focal One® Robotic HIFU versus surgery in prostate cancer management. The company also initiated a Phase I/II study for Benign Prostatic Hyperplasia (BPH) treatment.
Financial results show total Q4 2024 revenue of USD 21.5 million, up 3.6% year-over-year, with a gross profit margin of 44.8%. The company reported a Q4 net loss of USD 2.1 million and held cash reserves of USD 30.9 million as of December 31, 2024.
EDAP TMS SA (Nasdaq: EDAP), the global leader in robotic energy-based therapies, has scheduled its Fourth Quarter and Full Year 2024 financial results announcement for March 27, 2025, before markets open. The company will host a conference call and webcast at 8:30 AM EDT on the same day.
The earnings discussion will be led by Ryan Rhodes (CEO), Ken Mobeck (CFO), and François Dietsch (Chief Accounting Officer). Interested parties can access the call through domestic (1-800-225-9448) or international (1-203-518-9708) dial-in numbers using the passcode EDAP.
EDAP TMS SA (Nasdaq: EDAP), the global leader in robotic energy-based therapies, has appointed Glen French to its Board of Directors. French brings over 25 years of experience in medical device development and commercialization.
French's notable achievements include co-founding and selling three medical device companies and taking a fourth public. As CEO of Pulmonx (NASDAQ: LUNG), he led the company to over 20% compound annual revenue growth and a successful IPO raising $218.5 million. He previously served as President of Pulmonary Endoscopy at Boston Scientific and held CEO positions at Asthmatx and Broncus Technologies.
The appointment aims to support EDAP's strategic growth of its Focal One robotic HIFU technology platform, which targets prostate cancer treatment with potential applications in endometriosis, benign prostatic hyperplasia, and pancreatic cancer.
Cortechs.ai and EDAP TMS (NASDAQ: EDAP) announced the world's first successful OnQ Prostate-assisted Focal One® Robotic HIFU procedure at the UCSF Prostate Cancer Center. The procedure, performed on January 28th, 2025, marks the first clinical application of OnQ Prostate's RSI technology in focal therapy.
OnQ Prostate, the only FDA-cleared solution for RSI-MRI, provides detailed tissue microstructure information to help urologists identify suitable candidates for focal therapy and target specific lesions. The technology integrates with focal therapy systems for real-time precision targeting during procedures.
Dr. Matthew R. Cooperberg, who performed the procedure, noted that OnQ Prostate clearly delineated tumor anatomy and helped map out a complex treatment plan. The technology aims to improve and standardize prostate MRI interpretation across various contexts in prostate cancer treatment.
EDAP TMS SA (Nasdaq: EDAP), a leader in robotic energy-based therapies, announced preliminary record sales for its Focal One® System in Q4 2024.
The company reported worldwide sales of 11 Focal One Systems, a record for the fourth quarter. In the U.S., both system sales and procedures reached record highs, with a 30% year-over-year growth in procedures.
According to CEO Ryan Rhodes, the strong performance reflects the growing adoption of Focal One Robotic HIFU technology, which is changing how urologists manage prostate cancer. The recent publication of the HIFI study in European Urology is expected to further boost awareness and adoption.
Entering 2025, EDAP anticipates continued growth in the adoption of Focal One technology by urology practices. The preliminary data is subject to final financial reporting processes, with final Q4 results expected in March.
EDAP TMS SA (Nasdaq: EDAP) has appointed Joshua H. Levine to its Board of Directors. Levine brings extensive executive experience in the medical technology sector, with a proven track record of growing shareholder value through transformative business strategies.
Levine previously served as President, CEO, and Director of Accuray Incorporated (2012-2022), where he led a turnaround resulting in consistent top-line growth and positive operating profit. His prior roles include CEO positions at Immucor Inc. (acquired by TPG Capital for $2 billion) and Mentor (acquired by Johnson & Johnson for $1.2 billion).
The appointment comes as EDAP continues to expand its Focal One robotic HIFU platform, which is transforming prostate cancer treatment. The company aims to extend this technology to other therapeutic areas, including endometriosis and BPH.
EDAP TMS SA (NASDAQ: EDAP) has announced the successful treatment of the first patient in a phase I/II PULS Trial evaluating their proprietary High Intensity Focused Ultrasound (HIFU) technology for pancreatic tumors. The trial, sponsored by Centre Léon Bérard in Lyon, France, aims to assess both the tolerance and preliminary efficacy of intraoperative HIFU intervention on pancreatic lesions.
The first procedure was completed as planned, with the patient discharged without complications. This development represents a potential new treatment option for locally advanced pancreatic cancer patients, who currently have treatment options beyond chemotherapy and radiotherapy.
The trial's significance is highlighted by pancreatic cancer statistics: a five-year survival rate of just 11.5% across all stages (2012-2018 data), with 62,210 projected new cases and 49,830 projected deaths in the U.S. for 2022. Pancreatic cancer remains the third leading cause of cancer deaths, after lung and colorectal cancers.
EDAP TMS SA (Nasdaq: EDAP) announced the publication of the HIFI study results in European Urology, comparing Focal One® Robotic HIFU to radical prostatectomy (RP) for localized prostate cancer treatment. The landmark study, involving 3,328 patients across 46 centers, demonstrated that Focal One Robotic HIFU is non-inferior to surgery for Salvage Treatment-free Survival at 30 months.
Key findings show that the HIFU arm achieved 90% adjusted STFS compared to 86% in the RP arm. HIFU patients experienced significantly better outcomes in urinary continence (29% vs 44% deterioration) and erectile function. These superior functional results were achieved despite HIFU patients being approximately 9.6 years older than RP patients (median age 74.7 vs 65.1 years).
EDAP TMS (Nasdaq: EDAP), a leader in robotic energy-based therapies, announced its participation in the Piper Sandler 36th Annual Healthcare Conference in New York City. CEO Ryan Rhodes will engage in a fireside discussion and conduct one-on-one investor meetings during the event, scheduled for December 3-5, 2024. The fireside chat is set for Tuesday, December 3rd, from 4:00-4:25 PM EST. Both live and archived webcasts will be available through the company's investor relations website section.
EDAP TMS SA announced a scientific presentation demonstrating the technical feasibility of their Focal One® Robotic HIFU technology to perform non-thermal histotripsy energy delivery. The study, presented at the 187th Acoustical Society of America meeting, showed the system's capability to generate histotripsy lesions in biological tissues ex vivo. Histotripsy is a non-ionizing, non-thermal, and noninvasive technique for tissue ablation that uses microsecond ultrasound pulses for mechanical tissue destruction. The company views this as a significant technical milestone alongside their development of real-time elastography for ablation treatment confirmation.
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