EDAP TMS SA - EDAP STOCK NEWS

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.

EDAP TMS announced positive results from the Endo-HIFU-R1 Phase 2 study, focused on the safety of Focal One® HIFU treatment for rectal endometriosis. Presenting at the Paris Santé Femmes Congress on January 27, the study revealed a 96.7% safety profile with non-significant adverse events. Enrolling 60 patients, the study demonstrated a marked improvement in endometriosis symptoms and quality of life over six months post-treatment. Following these results, EDAP plans to start a randomized, double-blind, SHAM-controlled study in Q2 2023 to confirm efficacy. This milestone showcases the potential of HIFU as a non-invasive alternative to traditional surgery.

EDAP TMS SA reported strong performance for its Focal One HIFU technology in Q4 2022, placing nine machines in the U.S., including seven sales. The placements were made across both academic medical centers and community hospitals. CEO Marc Oczachowski emphasized the momentum in the market, while Ryan Rhodes highlighted the increasing awareness of Focal One as a viable treatment for prostate cancer. EDAP TMS aims to build on this success throughout 2023.

EDAP TMS SA has appointed Ken Mobeck as Chief Financial Officer for its U.S. subsidiary, EDAP Technomed Inc. With over 25 years of experience in finance, he previously held significant roles at Accuray and Lumentum, enhancing operational performance and driving revenue growth. This strategic hire aims to bolster the company's leadership team and support the expansion of the Focal One® Robotic HIFU platform in the U.S. market, which is critical for EDAP's growth trajectory.

EDAP TMS SA (Nasdaq: EDAP) has received approval to start a Phase 3 clinical trial for Focal One high intensity focused ultrasound (HIFU) targeting rectal deep infiltrating endometriosis. The trial, beginning in Q2 2023, will enroll 60 subjects across eight centers in France, assessing acute pelvic pain three months post-treatment. This initiative follows a completed Phase 2 study, with results expected to be presented in early 2023. The CEO emphasized the significance of this trial in building clinical evidence for HIFU as a treatment for this debilitating condition.

EDAP reported strong Q3 2022 results with total revenue of approximately EUR 12.2 million (USD 12.3 million), a 29.7% increase from EUR 9.4 million (USD 11.1 million) in Q3 2021. Year-to-date revenue rose 30.9% to EUR 39.4 million (USD 41.7 million). HIFU sales surged 81% year-over-year, contributing EUR 3.5 million (USD 3.5 million) in Q3. The company ended the quarter with a cash position of EUR 68.3 million (USD 66.8 million).

The U.S. CMS increased reimbursement for HIFU prostate ablation, boosting potential hospital revenue by over 90%.