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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 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.
EDAP TMS SA reported unaudited financial results for Q3 2021, revealing year-to-date revenue of approximately EUR 30.1 million (USD 35.9 million), a 14.4% increase compared to 2020. Q3 revenue remained flat at EUR 9.4 million (USD 11.1 million), impacted by COVID-19 on capital equipment sales. U.S. HIFU treatment volumes rose 58% year-to-date, highlighting strong adoption by urologists. Despite a strong cash position of EUR 45.4 million (USD 52.6 million), Q3 saw a gross profit margin decline to 38.4% due to reduced sales effects on fixed costs. The company will host a conference call on November 18, 2021.
EDAP TMS SA (Nasdaq: EDAP) announced its plans to release third quarter financial results for the period ended September 30, 2021, after market close on November 17, 2021. The company will host a conference call and webcast on November 18, 2021, at 8:30 AM ET, featuring key executives including the CEO and CFO. This event will discuss the financial results and future outlook.
EDAP is recognized for developing minimally invasive medical devices using ultrasound technology for various medical conditions.
EDAP TMS SA (Nasdaq: EDAP) has announced that the University of Washington Medicine will implement the Focal One® high intensity focused ultrasound (HIFU) technology for prostate cancer treatment at its UW Medical Center location. This partnership aims to enhance prostate cancer management through advanced imaging and targeted treatments. Marc Oczachowski, CEO of EDAP, emphasized the global adoption of their technology. The Focal One system offers precise ablation capabilities while minimizing side effects, indicating a significant advancement in prostate cancer care.
EDAP TMS SA (Nasdaq: EDAP) announced data from studies presented at the AUA 2021 Annual Meeting indicating the superiority of High-Intensity Focused Ultrasound (HIFU) over radical prostatectomy for prostate cancer treatment.
The studies revealed that Focal One technology maintained better erectile function and urinary continence, with a salvage-treatment-free survival rate of 97.5% compared to 90.3% for radical prostatectomy. EDAP's advancements in minimally invasive therapies reinforce its position as a leader in the therapeutic ultrasound market.
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