EDAP TMS reported record Focal One System sales for Q4 2024, reflecting increased adoption in prostate cancer treatment.
Quiver AI Summary
EDAP TMS SA announced preliminary record sales of 11 Focal One Systems in the fourth quarter of 2024, reflecting strong demand for its Focal One Robotic HIFU technology, which is increasingly adopted for prostate cancer treatment. The year-over-year growth of 30% in the number of Focal One procedures further indicates a shift towards this technology as a mainstream option among urologists. CEO Ryan Rhodes highlighted expectations for continued growth in 2025 and cited the impact of a recent study published in European Urology on raising awareness. The final fourth-quarter financial results will be released in March, and the company remains optimistic about its evolving pipeline and market presence.
Potential Positives
- EDAP TMS reported a preliminary record of 11 Focal One System sales in the fourth quarter of 2024, indicating strong market demand for their technology.
- The company experienced a record number of Focal One procedures in the U.S., showing a significant year-over-year growth of 30%, which highlights the increasing adoption of their treatment option.
- The CEO emphasized the transformative impact of the Focal One Robotic HIFU technology on prostate cancer management, suggesting positive implications for future market potential and company growth.
- The anticipated publication of the HIFI study in a prestigious journal may enhance awareness and adoption of the Focal One technology, potentially driving further sales growth in 2025.
Potential Negatives
- Despite reporting record sales, the press release emphasizes that the information is preliminary and subject to completion of quarter-end financial reporting processes and reviews, which may lead to potential adjustments or disappointments in actual results.
- The forward-looking statements include numerous risks and uncertainties that could materially affect the company's anticipated results, including market acceptance and potential impacts from global economic conditions.
- The release mentions ongoing reliance on the market potential of other divisions, implying that the company's future success may not be solely dependent on the Focal One System.
FAQ
What are the record sales reported for the fourth quarter of EDAP's Focal One Systems?
EDAP reported preliminary record sales of 11 Focal One Systems in the fourth quarter of 2024.
How much did the number of Focal One procedures grow year-over-year?
The number of Focal One procedures grew by 30% year-over-year, indicating strong adoption.
What is the significance of the HIFI study published in European Urology?
The HIFI study publication is expected to drive awareness and adoption of Focal One as a treatment option for prostate cancer.
When does EDAP plan to release final financial results?
EDAP expects to release its final fourth quarter financial results in March 2025.
What technology does EDAP TMS specialize in?
EDAP TMS specializes in robotic energy-based therapies, developing minimally invasive medical devices using ultrasound technology.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
$EDAP Hedge Fund Activity
We have seen 13 institutional investors add shares of $EDAP stock to their portfolio, and 14 decrease their positions in their most recent quarter.
Here are some of the largest recent moves:
- FEDERATED HERMES, INC. removed 520,689 shares (-64.4%) from their portfolio in Q3 2024
- PARKMAN HEALTHCARE PARTNERS LLC added 154,832 shares (+inf%) to their portfolio in Q3 2024
- ROCK SPRINGS CAPITAL MANAGEMENT LP added 93,000 shares (+6.3%) to their portfolio in Q3 2024
- SCHONFELD STRATEGIC ADVISORS LLC added 90,000 shares (+491.8%) to their portfolio in Q3 2024
- MANATUCK HILL PARTNERS, LLC removed 87,729 shares (-100.0%) from their portfolio in Q3 2024
- ARCHON CAPITAL MANAGEMENT LLC removed 74,283 shares (-6.5%) from their portfolio in Q3 2024
- SUMMIT TRAIL ADVISORS, LLC added 60,000 shares (+inf%) to their portfolio in Q3 2024
To track hedge funds' stock portfolios, check out Quiver Quantitative's institutional holdings dashboard.
Full Release
Company Reports Preliminary Worldwide Record Fourth Quarter Sales of 11 Focal One Systems
Record U.S. Fourth Quarter Focal One System Sales
Record Number of U.S. Focal One Procedures, with Year-Over-Year Growth of 30%
AUSTIN, Texas, January 13, 2025 -- EDAP TMS SA (Nasdaq: EDAP) (“the Company” or “EDAP”), the global leader in robotic energy-based therapies, today announced preliminary record Focal One System sales for the fourth quarter of calendar year 2024. The Company experienced robust demand for its Focal One Robotic HIFU technology, reporting preliminary record fourth quarter of 11 Focal One Systems.
“Our strong fourth quarter performance reflects the growing adoption of our industry-leading Focal One Robotic HIFU technology platform, which is fundamentally transforming how urologists manage prostate cancer,” said Ryan Rhodes, Chief Executive Officer of EDAP. “The number of Focal One procedures also continues to grow rapidly, underscoring the practice changing dynamics taking place as Focal One Robotic HIFU becomes a mainstream treatment option for patients with prostate cancer. As Focal One continues to grow, we also expect the recent publication of the groundbreaking HIFI study in the prestigious scientific journal,
European Urology,
will further drive awareness and adoption.”
“Entering 2025, our Focal One pipeline remains robust and strong, and we continue to expect a growing number of urology practices to adopt Focal One for men diagnosed with prostate cancer.”
The above information is preliminary and subject to completion of quarter-end financial reporting processes and reviews. EDAP expects to release final fourth quarter financial results in March.
About EDAP TMS SA
A recognized leader in the robotic energy-based therapies, EDAP TMS develops, manufactures, promotes and distributes worldwide minimally invasive medical devices for various conditions using ultrasound technology. By combining the latest technologies in imaging, robotics and precise non-invasive energy delivery, EDAP TMS introduced the Focal One
®
in Europe and in the U.S. as the leading prostate focal therapy controlled by urologists with the potential to expand to multiple indications beyond prostate cancer. For more information on the Company, please visit
http://www.edap-tms.com
,
us.hifu-prostate.com
and
www.focalone.com
.
Forward-Looking Statements
In addition to historical information, this press release contains forward-looking statements within the meaning of applicable federal securities laws, including Section 27A of the U.S. Securities Act of 1933 (the “Securities Act”) or Section 21E of the U.S. Securities Exchange Act of 1934, which may be identified by words such as “believe,” “can,” “contemplate,” “could,” “plan,” “intend,” “is designed to,” “may,” “might,” “potential,” “objective,” “target,” “project,” “predict,” “forecast,” “ambition,” “guideline,” “should,” “will,” “estimate,” “expect” and “anticipate,” or the negative of these and similar expressions, which reflect our views about future events and financial performance. Such statements are based on management's current expectations and are subject to a number of risks and uncertainties, including matters not yet known to us or not currently considered material by us, and there can be no assurance that anticipated events will occur or that the objectives set out will actually be achieved. Important factors that could cause actual results to differ materially from the results anticipated in the forward-looking statements include, among others, the clinical status and market acceptance of our HIFU devices and the continued market potential for our lithotripsy and distribution divisions, as well as risks associated with the current worldwide inflationary environment, the uncertain worldwide economic, political and financial environment, geopolitical instability, climate change and pandemics like the COVID 19 pandemic, or other public health crises, and their related impact on our business operations, including their impacts across our businesses or demand for our devices and services.
Other factors that may cause such a difference may also include, but are not limited to, those described in the Company's filings with the Securities and Exchange Commission and in particular, in the sections "Cautionary Statement on Forward-Looking Information" and "Risk Factors" in the Company's Annual Report on Form 20-F.
Forward-looking statements speak only as of the date they are made. Other than required by law, we do not undertake any obligation to update them in light of new information or future developments. These forward-looking statements are based upon information, assumptions and estimates available to us as of the date of this press release, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete.
Company Contact
Blandine Confort
Investor Relations / Legal Affairs
EDAP TMS SA
+33 4 72 15 31 50
bconfort@edap-tms.com
Investor Contact
John Fraunces
LifeSci Advisors, LLC
(917) 355-2395
jfraunces@lifesciadvisors.com
This article was originally published on Quiver News, read the full story.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.