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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 presented clinical data comparing Focal One HIFU versus surgery for treating deep infiltrating endometriosis at the 2024 AAGL Global Congress. The retrospective multicenter study analyzed 120 patients across two cohorts: 60 patients treated with HIFU and 60 with surgery. Results showed that HIFU therapy demonstrated significant advantages over surgical intervention, including fewer moderate and severe post-operative complications, shorter operating time, and reduced hospital stay. The company's ongoing Phase 3 trial shows promising progress, with over 85% of Sham treatment patients opting for HIFU therapy after symptoms returned.
EDAP TMS reported Q3 2024 worldwide revenue of EUR 13.1 million, up 11.6% year-over-year. HIFU revenue grew 48.2% to EUR 4.5 million, with 34% growth in U.S. Focal One procedures. The company sold three Focal One systems in Q3. Gross profit reached EUR 5.2 million with a 39.4% margin. Operating loss was EUR 5.8 million, and net loss was EUR 6.4 million. Notable developments include a new AI collaboration with Avenda Health, positive progress in BPH and endometriosis clinical trials, and CMS's 5.4% increase in Medicare Hospital Outpatient Focal One HIFU procedure payment for 2025.
EDAP TMS SA (Nasdaq: EDAP), a leader in robotic energy-based therapies, has announced its participation in the upcoming 2024 Jefferies London Healthcare Conference. CEO Ryan Rhodes will present and conduct one-on-one investor meetings during the event, scheduled for November 19-21, 2024. The presentation is set for Tuesday, November 19, at 8:30-8:55 AM GMT at The Waldorf Hilton London. Both live and archived webcasts of the presentation will be available through the company's website's Investor section.
EDAP TMS SA (Nasdaq: EDAP), a leader in robotic energy-based therapies, has scheduled its third quarter 2024 financial results release for November 7, 2024, before market open. The company will host a conference call and webcast at 8:30 AM EDT on the same day. CEO Ryan Rhodes, CFO Ken Mobeck, and CAO François Dietsch will lead the discussion. The conference call will be accessible via domestic (1-800-445-7795) and international (1-785-424-1699) dial-in numbers using passcode EDAP.
EDAP TMS SA (Nasdaq: EDAP) has announced the initiation of a Phase I/II study evaluating its Focal One® robotic high-intensity focused ultrasound (HIFU) technology for treating benign prostatic hyperplasia (BPH). The first patients have been treated in this study, which aims to explore a less invasive treatment option for BPH.
The study is designed in two parts: Part 1 will define optimal treatment parameters at two leading academic centers in France, while Part 2 will validate safety and efficacy across multiple centers. Dr. Harry Toledano, Head of Urology at Martigues Hospital, expressed enthusiasm about the potential of HIFU to improve BPH symptoms with minimal side effects.
EDAP's CEO, Ryan Rhodes, highlighted the significant need for less invasive BPH treatments and sees this as a logical expansion of their technology beyond prostate cancer applications. The company plans to initiate a BPH clinical study in the United States next year based on this foundational research.
EDAP TMS SA (Nasdaq: EDAP) and Avenda Health have launched the world's first AI-assisted Focal One® Robotic HIFU procedures for prostate cancer treatment. The collaboration integrates Avenda's FDA-cleared Unfold AI® technology with EDAP's Focal One robotic HIFU platform. Unfold AI creates 3D patient-specific cancer maps, enabling more precise tumor targeting and healthy tissue preservation.
The first AI-assisted procedures were successfully performed at UCLA School of Medicine. This integration aims to provide more tailored, patient-specific HIFU ablation for prostate cancer patients. The companies will present simulated procedures at the 2024 Joint Meeting of the Focal Therapy Society & Society of Urologic Robotic Surgeons in Washington, DC.
EDAP TMS SA (Nasdaq: EDAP), a leader in robotic energy-based therapies, announced its participation in the H.C. Wainwright 26th Annual Global Investment Conference. The event is scheduled for September 9-11, 2024, in New York City. Ryan Rhodes, EDAP's CEO, will engage in a fireside chat and conduct one-on-one investor meetings.
Key details:
- Date: Tuesday, September 10th, 2024
- Time: 3:00-3:30 PM ET
- Location: Lotte New York Palace Hotel
EDAP TMS SA reported record Q2 2024 total worldwide revenue of EUR 15.8 million (USD 17.0 million), a 10.6% increase over Q2 2023. The company experienced strong U.S. Focal One® HIFU procedure growth of 63% year-over-year. Key highlights include:
- Five Focal One systems placed in Q2, including two at NCI-designated comprehensive cancer centers
- Strong year-over-year procedure growth indicating increasing adoption of robotic HIFU
- Appointment of new board member and strengthened European commercial leadership
- Presentation of final HIFI study results at AUA 2024, showing Focal One as effective as radical prostatectomy for localized prostate cancer
- Interim results from Phase 3 endometriosis study and approval to initiate Phase 1-2 BPH clinical trial
Despite revenue growth, the company reported an operating loss of EUR 6.1 million for Q2 2024, compared to EUR 4.2 million in Q2 2023, due to increased investments in commercial and R&D functions.
EDAP TMS SA (Nasdaq: EDAP), the global leader in robotic energy-based therapies, has announced it will release its financial results for the second quarter ended June 30, 2024, before markets open on Wednesday, August 28th, 2024. The company will host a conference call and webcast on the same day at 8:30am EDT.
The call will be conducted by Ryan Rhodes (CEO), Ken Mobeck (CFO), and François Dietsch (Chief Accounting Officer). Investors can join the call using the provided domestic and international dial-in numbers or through the webcast link.
EDAP TMS SA (Nasdaq: EDAP) announced that its robotic HIFU technology platform, Focal One, will be featured at the 41st World Congress of Endourology and Uro-Technology (WCET 2024) in Seoul, South Korea, from August 12-16, 2024. The event will showcase a semi-live Focal One clinical procedure conducted by Dr. Tarik Benidir from the University of Florida on August 15th at 5:00 pm (KST).
CEO Ryan Rhodes highlighted the increasing interest from urologists in using non-invasive HIFU technology for prostate cancer management. The company will provide hands-on Focal One simulations for attending urologists, demonstrating EDAP's significant presence at the conference and the growing trend in HIFU technology adoption.
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