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EDAP TMS SA (Nasdaq: EDAP) is described in its filings and press releases as a global leader in robotic energy-based therapies, focused on High-Intensity Focused Ultrasound (HIFU) and related ultrasound-based medical devices. The EDAP news feed on Stock Titan aggregates company announcements, financial updates and regulatory disclosures so readers can follow developments around its Focal One Robotic HIFU platform and broader therapeutic ultrasound portfolio.
Recent news from EDAP highlights HIFU revenue growth, system placements and procedure volumes, as well as guidance on expected revenue trends in its core HIFU business and non-core ESWL and Distribution segments. The company regularly reports unaudited quarterly financial results via Form 6-K, including details on sales of medical equipment, recurring revenue programs, and spare parts and services, along with commentary on gross margins and operating performance.
Investors and healthcare observers can also use the news stream to track regulatory milestones and clinical adoption. EDAP has announced FDA 510(k) clearance for new ultrasound imaging and workflow enhancements to the Focal One HIFU system, as well as reimbursement in France for Focal One Robotic HIFU procedures in prostate cancer under the national universal health system. News items further cover recognition such as an Industry Award for Innovations in Endourological Instrumentation for the Focal One platform.
Other news categories include financing and capital structure updates, such as a multi-tranche credit facility with the European Investment Bank intended to support expansion of the Focal One platform, and information about EDAP’s transition from foreign private issuer to U.S. domestic filer status. Coverage of conference presentations and investor meetings provides additional context on how management presents the company’s strategy in urology, prostate cancer and benign disease markets.
By reviewing the EDAP news page, readers can follow company-reported trends in HIFU adoption, reimbursement developments, clinical evidence references and financial guidance, all drawn from EDAP’s own press releases and SEC-reported materials.
EDAP TMS SA reported first quarter 2022 revenue of approximately EUR 13.0 million (USD 14.5 million), reflecting a 26% increase year-over-year. The company sold four Focal One units in Q1 2022, compared to none in Q1 2021. Total revenue from the HIFU business was EUR 3.8 million (USD 4.3 million), significantly up from EUR 1.8 million (USD 2.2 million). However, LITHO business revenue declined to EUR 2.2 million (USD 2.5 million). Gross profit improved to EUR 5.8 million (USD 6.4 million), with a gross margin of 44.3%. As of March 31, 2022, cash reserves were EUR 46.5 million (USD 51.6 million).
EDAP TMS SA (Nasdaq: EDAP) will announce its Q1 2022 financial results on May 17, 2022, after market close. A conference call will take place on May 18, 2022, at 8:30 am EDT, featuring key executives including Marc Oczachowski and Ryan Rhodes. This event will provide insights into the company's performance in the therapeutic ultrasound market, where it leads in minimally invasive medical devices for prostate treatment.
More information and registration details are available through the webcast link.
EDAP TMS SA (Nasdaq: EDAP) will showcase its Focal One® Robotic HIFU platform at the AUA annual meeting from May 13-15 in New Orleans, highlighting its role in prostate cancer treatment. The event will include presentations by leading academic centers on the clinical acceptance of focal therapy. Ryan Rhodes, CEO of EDAP U.S., expressed confidence in Focal One® as advanced technology. Attendees will also experience hands-on training with Focal One® and ExactVu™ Micro-Ultrasound at the EDAP booth, demonstrating its complete solution for prostate cancer diagnostics and treatment.
EDAP TMS SA (Nasdaq: EDAP) announced the placement of three Focal One® machines in prestigious U.S. academic centers during Q1 2022, signaling a strong demand for robotic focal therapy. The placements include New York-Presbyterian/Weill Cornell, Beth Israel Deaconess Lahey Health, and UC Davis Medical Center, the latter marking its fourth installation in the University of California Health System. Additionally, five ExactVu micro-ultrasound systems were sold. The company plans to report full financial results for Q1 2022 in mid-May, highlighting ongoing momentum in prostate cancer treatment technologies.
EDAP TMS SA reported unaudited financial results for 2021, achieving total revenue of EUR 44.1 million (USD 51.9 million), a 5.8% increase from 2020. Notably, US HIFU treatment volumes surged by 65%, reflecting higher adoption rates among urologists. However, the HIFU segment saw a revenue decline to EUR 9.9 million (USD 11.7 million) from EUR 11.4 million (USD 13.1 million) in 2020. Operating loss reached EUR 1.6 million (USD 1.9 million), contrasting with a profit in 2020. The company ended the year with a strong cash position of EUR 47.2 million (USD 53.4 million).
EDAP TMS SA will release its financial results for Q4 2021 on March 30, 2022, after market close. The company will host a conference call on March 31, 2022, at 8:30 am ET, featuring key executives including CEO Marc Oczachowski and CFO François Dietsch. EDAP is a leader in therapeutic ultrasound, offering products such as the Focal One® and ExactVu™ for prostate cancer treatment. The call will provide insights into the company's performance and future outlook, key points for investors to consider.
EDAP TMS SA, a leader in robotic energy-based therapies, reported a remarkable 65% increase in U.S. HIFU treatment volumes for 2021, indicating strong adoption of their Focal One technology despite pandemic challenges. The company expanded its U.S. presence, placing Focal One devices in prestigious hospitals. Additionally, progress was made in R&D, particularly in evaluating HIFU for treating rectal endometriosis and pancreatic cancer. With a solid cash position and successful fourth-quarter momentum, EDAP anticipates a productive 2022, aiming to capitalize on their growth strategy.
EDAP TMS has published promising pre-clinical results in the peer-reviewed journal Cancers, showcasing the potential of high intensity focused ultrasound (HIFU) for treating locally advanced pancreatic cancer. The study found that HIFU can induce irreversible tissue necrosis rapidly, highlighting its feasibility under Doppler guidance. This research paves the way for a forthcoming Phase I clinical study, aiming to evaluate the safety and efficacy of HIFU in patients with this challenging cancer type. The overall 5-year survival rate for patients with locally advanced pancreatic adenocarcinoma is under 5%, underscoring the need for innovative treatment options.
EDAP TMS announced notable growth for its Focal One device in the U.S., with installations at five leading healthcare centers, including Brigham and Women’s Hospital and Cedars-Sinai, during Q4 2021.
CEO Marc Oczachowski expressed optimism regarding increased market adoption following a restructuring of U.S. operations.
Ryan Rhodes, CEO of EDAP U.S., highlighted the device's significance in prostate oncology as they enter 2022 with strong momentum.
EDAP TMS SA (Nasdaq: EDAP) announced its participation in the Piper Sandler 33rd Annual Virtual Healthcare Conference from November 29 to December 2, 2021. The company will engage in investor 1x1 meetings on November 30. A video replay of the fireside chat will be available on EDAP's website post-event. EDAP TMS is recognized for its innovative robotic energy-based therapies, particularly in the therapeutic ultrasound market, with products like the Focal One® and ExactVu™ aimed at prostate cancer treatment.