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EDAP TMS SA (NASDAQ: EDAP) is a global leader in therapeutic ultrasound with over 30 years of experience. The company develops, manufactures, promotes, and distributes minimally-invasive medical devices for urology using advanced ultrasound technology. With a robust presence worldwide through a network of corporate offices, subsidiaries, and distribution partners, EDAP TMS is committed to innovation and excellence.
EDAP TMS operates through three main divisions:
- HIFU (High-Intensity Focused Ultrasound): This division focuses on the development and marketing of devices for the non-invasive destruction of tumors. Key products include Ablatherm, Ablatherm Fusion, and the Focal One, which is the latest addition designed for ideal focal therapy of localized prostate cancer.
- ESWL (Extracorporeal ShockWave Lithotripsy): This division manufactures and services the Sonolith range of lithotripters, which are used for the treatment of kidney stones.
- Distribution: This division markets complementary products such as lasers, micro-ultrasound systems, and other medical devices from third-party suppliers.
EDAP TMS is known for its strong patent portfolio thanks to continuous investment in research and development. The company collaborates with globally acclaimed medical research institutions to push the boundaries of medical technology. Financially, EDAP TMS reported a gross profit of EUR 24.4 million (USD 26.4 million) for the year ending December 31, 2023, reflecting a slight increase from the previous year. However, the gross profit margin declined due to inflationary pressures and investments in U.S. operations to support long-term revenue growth.
Recent achievements include the launch of the Focal One and strategic partnerships to expand its product reach. The company’s commitment to innovation and patient care makes it a significant player in the medical device industry.
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%.
EDAP TMS SA (Nasdaq: EDAP) will release its third-quarter financial results for the period ending September 30, 2022, on November 16, 2022, after market close. A conference call will follow on November 17, 2022, at 8:30 AM EDT, featuring key executives including Marc Oczachowski, Ryan Rhodes, and François Dietsch. The company is recognized for its innovations in robotic energy-based therapies, particularly in the ultrasound market, offering products such as Focal One® and ExactVu™ for prostate cancer treatment.
EDAP TMS SA announced a significant increase in Medicare reimbursement for the Focal One HIFU prostate ablation procedure, effective January 1, 2023. The reimbursement will rise to $8,558 per procedure, a 90% increase from the current $4,506. This adjustment reflects CMS's recognition of the value of HIFU therapy, potentially expanding access to patients and influencing commercial payors. The management views this as a crucial step for prostate cancer treatment and plans to discuss its impact during the upcoming Q3 2022 results conference call.
EDAP TMS SA (Nasdaq: EDAP) will host a urology expert panel and live demonstration of its Focal One® technology on September 29, 2022, at 8 AM ET at the Langham Hotel in New York City. The event will feature presentations from the U.S. CEO and leading prostate cancer experts, followed by a live Q&A session. EDAP TMS is recognized for its advancements in robotic therapeutic ultrasound and offers a comprehensive solution for prostate cancer treatment. The company aims to enhance market acceptance of its HIFU devices amidst ongoing challenges from the COVID-19 pandemic.
EDAP TMS S.A. announced a public offering of 2,666,667 American Depositary Shares (ADSs) priced at $7.50 each on September 22, 2022. The offering aims to raise approximately $20 million before expenses. Jefferies LLC will act as the sole book-running manager and has a 30-day option to purchase an additional 400,000 ADSs. The offering's closing is anticipated on September 27, 2022, subject to customary conditions. The initial registration statement for this offering was filed with the SEC in April 2021.
EDAP TMS announced a public offering of its American Depositary Shares (ADSs) on September 22, 2022, with Jefferies LLC as the sole book-running manager. The offering's completion and terms are subject to market conditions, and there are no assurances regarding these aspects. A shelf registration statement effective since April 7, 2021, is in place for the offering. Investors are advised to review the preliminary prospectus supplement and associated documents before purchasing. The offering will not take place in Europe, and forward-looking statements are subject to various uncertainties.
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