EDAP Announces Preliminary Fourth Quarter Record Focal One® System Sales and Placements
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Insights
The preliminary placement results of EDAP TMS SA's Focal One Systems indicate a strong market demand for non-invasive, robotic energy-based therapies. The Focal One technology, which employs High-Intensity Focused Ultrasound (HIFU) for treating prostate cancer, represents a significant advancement in the field of urology. The technology's ability to offer tissue-sparing treatment aligns with the increasing trend towards personalized and less aggressive treatment options that prioritize quality of life.
From an industry perspective, the adoption by both academic medical centers and community hospitals suggests a broadening market acceptance, which could translate into increased market penetration and recurring revenue streams from service agreements and future upgrades. The reported record sales of ExactVu™ Micro-Ultrasound systems also complement the Focal One placements, as they are used for prostate biopsy, indicating a strategic synergy in product offerings that could enhance overall company performance.
EDAP's announcement of a record-setting quarter in terms of capital sales and overall system placements is a positive indicator for future revenue growth and profitability. The capital sales of the Focal One systems are particularly noteworthy as they represent a more significant upfront investment by customers and a strong commitment to EDAP's technology. This could imply an increase in the company's market share and a solidification of its position as a leader in the sector.
Investors should monitor the final fourth quarter financial results closely, as they will provide a clearer picture of the company's financial health and the actual impact of these placements on the bottom line. It is essential to consider the company's operational costs, research and development expenses and the scalability of production to meet growing demand. These factors will play a crucial role in determining the long-term sustainability of EDAP's growth trajectory.
The growing interest from diverse healthcare institutions in the Focal One technology indicates a shift in treatment paradigms towards minimally invasive procedures in urology. This shift is likely driven by both technological advancements and patient preference for treatments with fewer side effects and shorter recovery times. The market for such technologies is expected to expand as the global population ages and the prevalence of prostate cancer rises.
Competitive analysis should be considered, assessing how EDAP's Focal One system compares with other HIFU technologies and alternative treatments for prostate cancer. Factors such as cost-effectiveness, clinical outcomes and ease of integration into existing medical practices will be critical in determining the system's adoption rate and market growth potential. Understanding these dynamics will be essential for stakeholders to anticipate future market trends and the company's strategic positioning.
Company reports preliminary placement results of twelve Focal One Systems, inclusive of ten capital sales
LYON, France, January 8, 2024 - EDAP TMS SA (Nasdaq: EDAP), (“EDAP”), the global leader in robotic energy-based therapies, announced today preliminary Focal One placement results for the fourth quarter of calendar year 2023. The Company experienced robust demand for its Focal One robotic HIFU technology, placing twelve Focal One systems, inclusive of ten capital sales. Additionally, it was a record quarter for sales of ExactVu™ Micro-Ultrasound systems used for prostate biopsy. The breadth of these new Focal One and ExactVu placements continues to be strong, with growing interest amongst both academic medical centers and community hospitals.
“Our Focal One commercial team continues to gain significant momentum as reflected by our record-setting number of capital sales as well as overall system placements in the fourth quarter of 2023,” said Ryan Rhodes, Chief Executive Officer of EDAP. “Utilizing our state-of-the-art robotic technology platform, a growing number of urologists can now offer their patients a non-invasive, tissue-sparing treatment option that provides excellent oncologic outcomes with the opportunity for preserving patient quality of life. Looking ahead, we believe Focal One is quickly becoming a necessary solution in the management of prostate cancer, and our team is leading the effort to help urology practices establish world-class treatment programs with our Focal One platform.”
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 global therapeutic ultrasound market, EDAP TMS develops, manufactures, promotes and distributes worldwide minimally invasive medical devices for various pathologies using ultrasound technology. By combining the latest technologies in imaging and treatment modalities in its complete range of Robotic HIFU devices, EDAP TMS introduced the Focal One® in Europe and in the U.S. as an answer to all requirements for ideal prostate tissue ablation. With the addition of the ExactVu™ Micro-Ultrasound device, EDAP TMS is now the only company offering a complete solution from diagnostics to focal treatment of Prostate Cancer. EDAP TMS also produces and distributes other medical equipment including the Sonolith® i-move lithotripter and lasers for the treatment of urinary tract stones using extra-corporeal shockwave lithotripsy (ESWL). 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
FAQ
What are the preliminary placement results announced by EDAP TMS SA (Nasdaq: EDAP)?
What technology experienced robust demand according to the press release?
What sales record was achieved in the fourth quarter of 2023?
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