EDAP TMS SA - EDAP STOCK NEWS

EDAP TMS SA (Nasdaq: EDAP) announced it will showcase its Focal One® Robotic High Intensity Focused Ultrasound (HIFU) platform for prostate cancer management at the Annual Meeting of the American Urological Association (AUA), scheduled for April 28-May 1 in Chicago, IL. This year, EDAP will have its largest presence at the AUA, featuring Focal Therapy discussions and hands-on demonstrations. Key urologists will present the advantages of HIFU therapy, emphasizing its efficacy in meeting oncological standards while preserving patient quality of life. The AUA meeting highlights the ongoing clinical acceptance and adoption of EDAP's technology among physicians worldwide.

EDAP TMS SA (Nasdaq: EDAP) announced a webcast scheduled for April 18, 2023, at 12:00 p.m. PDT, showcasing its Focal One HIFU technology for prostate cancer treatment. The live demonstration will be conducted by Dr. Andre Abreu and Dr. Amir H. Lebastchi from Keck Medicine of USC, highlighting advancements in non-invasive treatment options. CEO Ryan Rhodes emphasized the importance of collaboration with leading academic centers to enhance patient outcomes through innovative therapies. USC has been instrumental in adopting EDAP's technology, focusing on the effectiveness and quality of life improvements for prostate cancer patients. The webcast aims to educate healthcare professionals on best practices in using robotic high intensity focused ultrasound (HIFU) for precise cancer treatment.

EDAP TMS has received approval from Japan's PMDA for the commercialization of its ExactVu™ micro-ultrasound biopsy platform. This platform is significant as it offers the only micro-ultrasound technology for precision prostate biopsies, a critical need considering Japan has over 100,000 new prostate cancer diagnoses annually. The ExactVu utilizes a unique 29MHz frequency, allowing for detailed visualization of prostate tissues during biopsies. With its existing sales in the EU and the US, this expansion into Japan taps into the world's second-largest market for advanced medical devices. CEO Marc Oczachowski expressed confidence in their commercial team's ability to engage clinical sites effectively.

EDAP TMS reported record total revenue of EUR 55.1 million ($58.0 million) for 2022, marking a 25.1% increase over 2021. The HIFU segment saw a significant rise, achieving EUR 15.6 million ($16.4 million), up 57.7%. Q4 2022 revenue reached EUR 15.7 million ($16.2 million), an increase of 12.8%. Operating loss widened to EUR 4.3 million ($4.5 million) for 2022, compared to a loss of EUR 1.6 million ($1.9 million) in 2021. The company had a strong cash position of EUR 63.1 million ($67.5 million) as of December 31, 2022. Additionally, Ryan Rhodes will take over as CEO on May 1, 2023.

EDAP TMS announced promising results from a multicenter study comparing High Intensity Focused Ultrasound (HIFU) to Radical Prostatectomy (RP) for localized prostate cancer. Conducted between April 2015 and September 2019 with 3,328 patients, the study revealed a salvage treatment-free survival rate of 90.1% for HIFU, surpassing RP's 86.8%. The HIFU group experienced lower urinary incontinence and better erectile function scores post-treatment. The results support HIFU's effectiveness and quality of life benefits, reinforcing its clinical value in prostate cancer management.

EDAP TMS SA (Nasdaq: EDAP) will announce its financial results for Q4 and full-year 2022 on March 30, 2023, before market opening. A conference call will occur at 8:30 AM ET, featuring CEO Marc Oczachowski, Ryan Rhodes, and CFO François Dietsch. EDAP TMS is recognized for its advancements in robotic energy-based therapies and has a complete range of Robotic HIFU devices, including the Focal One® for prostate tissue ablation, and the ExactVu™ Micro-Ultrasound device. The company is a leader in the therapeutic ultrasound market, focusing on minimally invasive medical devices.

The tumor ablation therapy devices market is projected to grow from $0.49 billion in 2021 to $0.97 billion by 2026, with a CAGR of 15%. Factors such as the increasing prevalence of cancer drive market growth, as cancer is responsible for 1 in 6 deaths globally. Major market players include EDAP TMS S.A., Medtronic, and Boston Scientific, focusing on technological advancements. However, product recalls due to safety concerns pose a challenge. North America leads the market, followed by Asia Pacific, indicating strong regional demand.

The Urology Laser Market is projected to grow at a CAGR of 6.42% from 2022 to 2029, driven by the rising prevalence of urological disorders and an aging population. Benign Prostate Hyperplasia is the largest application segment due to increasing cases globally. The report highlights critical insights into market regulations, emerging trends, and the competitive landscape, featuring key players like EDAP, Boston Scientific, and Olympus. Opportunities are noted in the demand for minimally invasive procedures and advancements in technology. However, challenges include high R&D costs and limited public awareness in some regions.

EDAP TMS SA reported record preliminary unaudited total revenue for full-year 2022 of €55.1 million ($58.0 million), marking a 25.1% increase from 2021, primarily driven by a 58.1% growth in HIFU sales. Q4 2022 revenue reached €15.8 million ($16.2 million), up from €14.0 million ($15.9 million) in Q4 2021. The company maintains a strong balance sheet with cash and cash equivalents totaling €63.1 million ($67.5 million) as of December 31, 2022. In 2022, EDAP sold 15 Focal One machines, more than doubling sales from the previous year, indicating increasing interest in their prostate cancer treatment solutions. The recently increased Medicare reimbursement may further bolster commercial momentum in 2023.