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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), a leader in robotic energy-based therapies, announced its participation in the Jefferies Virtual London Healthcare Conference from November 17-19, 2020. The presentation is scheduled for November 17 at 10:00 am BT. A webcast of the event will be available for replay for 90 days. EDAP focuses on minimally invasive medical devices, including its Focal One® for prostate ablation and ExactVu™ Micro-Ultrasound. Potential risks include market acceptance of its HIFU devices and impacts from COVID-19 on demand.
EDAP TMS SA (Nasdaq: EDAP), a leader in therapeutic ultrasound, will release its third-quarter financial results for 2020 after market close on November 18, 2020. A conference call, led by CEO Marc Oczachowski and CFO François Dietsch, is scheduled for November 19, 2020, at 8:30 AM EDT. This event will allow investors and stakeholders to discuss the results and future outlook. EDAP TMS is recognized for its minimally invasive ultrasound medical devices, including the Focal One® and ExactVu™ systems for prostate treatment.
EDAP TMS SA (Nasdaq: EDAP) will host a Key Opinion Leader call on September 22, 2020, at 8am ET to discuss its commercial products, Focal One® and ExactVu™. The call features Dr. Brian Miles and Dr. Laurence Klotz, who will explore the potential of Focal One® High Intensity Focused Ultrasound (HIFU) and ExactVu™ micro-ultrasound. Management will also update on sales achievements and pipeline expansion opportunities beyond prostate cancer.
EDAP TMS SA (Nasdaq: EDAP) has announced its participation in the HC Wainwright Virtual 22nd Annual Global Investment Conference on September 15, 2020, at 10:30 AM EDT. A webcast of the presentation will be available for replay for 90 days. EDAP is a leader in the global therapeutic ultrasound market, focusing on minimally invasive medical devices for urology. The company has developed and marketed advanced robotic HIFU devices, including the Focal One®.
EDAP TMS SA (Nasdaq: EDAP) has initiated a Phase 2 clinical trial of its Focal One® High Intensity Focused Ultrasound (HIFU) for treating deep rectal endometriosis. The trial will involve 38 women at five major hospitals over a six-month follow-up period. The first two patients have already been treated, with more sessions scheduled. According to Pr. Gil Dubernard, the lead investigator, recruitment is proceeding swiftly, providing optimism for advancing this promising treatment. Endometriosis affects around 176 million women globally, and HIFU may offer a minimally invasive alternative to standard surgical options.
EDAP TMS SA reported its second quarter 2020 results, showing total revenue of EUR 9.3 million, down 26% year-over-year due to the COVID-19 pandemic. HIFU revenue fell 44.2% to EUR 2.6 million, while Lithotripsy and Distribution revenues also declined. Gross profit decreased to EUR 4.3 million, with a margin of 46.8%. Operating profit was EUR 0.3 million, contrasting with a profit of EUR 1.7 million in Q2 2019. The company holds a strong cash position of EUR 15.7 million. Future expectations are optimistic as procedure volumes are anticipated to normalize.
EDAP TMS SA has received approval to start a Phase II multicenter clinical trial for its Focal One® HIFU technology to treat deep rectal endometriosis in France, involving 38 patients across five hospitals. The trial is set to begin in September, led by Pr. Gil Dubernard. Initial Phase I results indicated promising outcomes. The company aims to expand its HIFU applications amid rising endometriosis prevalence, affecting approximately 176 million women globally. The initiative aligns with EDAP's strategic focus on enhancing its HIFU pipeline for high-value medical indications.
EDAP TMS SA (Nasdaq: EDAP) announced it will release its second quarter financial results for 2020 on August 26, after market close. The financial results will be followed by a conference call hosted by CEO Marc Oczachowski and CFO François Dietsch on August 27 at 8:30 am EDT. The company specializes in therapeutic ultrasound and has been a leader in the field for nearly 40 years, focusing on minimally invasive medical devices for urology.
EDAP TMS SA has announced the publication of two studies in the Journal of Urology, detailing successful results of their high intensity focused ultrasound (HIFU) technology for treating prostate cancer. Conducted at USC and University of Miami, these studies demonstrate that 91% of patients avoided radical treatments after two years, with no major complications. The findings are consistent with positive European studies, further affirming the efficacy of EDAP's HIFU technology. These publications mark a significant milestone in the company's US market penetration strategy.
EDAP announced a strong sales performance during Q2 and early Q3 2020, including four sales of its Focal One systems, three of which were bundled with Exact Imaging’s ExactVu technology. New customers include Edouard Herriot University Hospital and Ochsner Medical Center, with a notable upgrade sale to Mount Sinai Health System. The CEO remarked on the recovery from COVID-19 related disruptions, noting a positive impact from their partnership with Exact Imaging. EDAP expects to maintain sales momentum through the remainder of the year and will provide further updates during the upcoming Q2 conference call.
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