EDAP Announces Preliminary Record Fourth Quarter Focal One® System Sales and Record U.S. Procedures
EDAP TMS SA (Nasdaq: EDAP), a leader in robotic energy-based therapies, announced preliminary record sales for its Focal One® System in Q4 2024.
The company reported worldwide sales of 11 Focal One Systems, a record for the fourth quarter. In the U.S., both system sales and procedures reached record highs, with a 30% year-over-year growth in procedures.
According to CEO Ryan Rhodes, the strong performance reflects the growing adoption of Focal One Robotic HIFU technology, which is changing how urologists manage prostate cancer. The recent publication of the HIFI study in European Urology is expected to further boost awareness and adoption.
Entering 2025, EDAP anticipates continued growth in the adoption of Focal One technology by urology practices. The preliminary data is subject to final financial reporting processes, with final Q4 results expected in March.
EDAP TMS SA (Nasdaq: EDAP), un leader nelle terapie robotiche basate sull'energia, ha annunciato vendite preliminari record per il suo Focal One® System nel quarto trimestre del 2024.
La società ha riportato vendite mondiali di 11 sistemi Focal One, un record per il quarto trimestre. Negli Stati Uniti, sia le vendite dei sistemi che le procedure hanno raggiunto livelli record, con una crescita del 30% rispetto all'anno precedente nelle procedure.
Secondo il CEO Ryan Rhodes, le forti performance riflettono l'adozione crescente della tecnologia Focal One Robotic HIFU, che sta cambiando il modo in cui gli urologi gestiscono il cancro alla prostata. La recente pubblicazione dello studio HIFI in European Urology dovrebbe ulteriormente aumentare la consapevolezza e l'adozione.
Entrando nel 2025, EDAP prevede una continua crescita nell'adozione della tecnologia Focal One da parte delle pratiche urologiche. I dati preliminari sono soggetti ai processi finali di reporting finanziario, con i risultati finali del quarto trimestre attesi per marzo.
EDAP TMS SA (Nasdaq: EDAP), un líder en terapias robóticas basadas en energía, anunció ventas preliminares récord para su Focal One® System en el cuarto trimestre de 2024.
La compañía reportó ventas mundiales de 11 sistemas Focal One, un récord para el cuarto trimestre. En los Estados Unidos, tanto las ventas de sistemas como los procedimientos alcanzaron cifras récord, con un crecimiento del 30% en procedimientos en comparación con el año anterior.
Según el CEO Ryan Rhodes, el sólido desempeño refleja la creciente adopción de la tecnología Focal One Robotic HIFU, que está cambiando la forma en que los urólogos manejan el cáncer de próstata. Se espera que la reciente publicación del estudio HIFI en European Urology impulse aún más la conciencia y la adopción.
Al entrar en 2025, EDAP anticipa un crecimiento continuo en la adopción de la tecnología Focal One por parte de las prácticas urológicas. Los datos preliminares están sujetos a los procesos finales de informes financieros, con los resultados finales del cuarto trimestre que se esperan en marzo.
EDAP TMS SA (Nasdaq: EDAP)는 로봇 에너지원 기반 치료의 선두주자로서 2024년 4분기 Focal One® System의 예비 기록 매출을 발표했습니다.
회사는 전 세계에서 11개의 Focal One 시스템이 판매되어 4분기 기록을 세웠습니다. 미국에서는 시스템 판매와 절차 모두 기록적인 수준에 도달했으며, 절차는 전년 대비 30% 성장했습니다.
CEO 라이언 로즈(Ryan Rhodes)에 따르면, 이러한 강력한 성과는 Focal One Robotic HIFU 기술의 채택 증가를 반영하며, 이는 비뇨기과 의사들이 전립선암을 관리하는 방식을 변화시키고 있습니다. 유럽 비뇨기학에 발표된 HIFI 연구의 최근 출판은 인지도와 채택을 더욱 촉진할 것으로 예상됩니다.
2025년에 접어들며 EDAP는 비뇨기과 진료에서 Focal One 기술의 채택이 지속적으로 성장할 것으로 기대하고 있습니다. 예비 데이터는 최종 재무 보고 프로세스에 따라 달라질 수 있으며, 4분기 최종 결과는 3월에 발표될 예정입니다.
EDAP TMS SA (Nasdaq: EDAP), un leader dans les thérapies robotiques basées sur l'énergie, a annoncé des ventes préliminaires record pour son Focal One® System au quatrième trimestre 2024.
L'entreprise a rapporté des ventes mondiales de 11 systèmes Focal One, un record pour le quatrième trimestre. Aux États-Unis, les ventes de systèmes et les procédures ont atteint des niveaux record, avec une croissance de 30 % d'une année sur l'autre dans les procédures.
Selon le PDG Ryan Rhodes, cette forte performance reflète l'adoption croissante de la technologie Focal One Robotic HIFU, qui change la façon dont les urologues gèrent le cancer de la prostate. La récente publication de l'étude HIFI dans European Urology devrait encore accroître la sensibilisation et l'adoption.
En entrant dans l'année 2025, EDAP prévoit une poursuite de la croissance de l'adoption de la technologie Focal One par les cabinets d'urologie. Les données préliminaires sont soumises à des processus ultérieurs de reporting financier, avec des résultats finaux du quatrième trimestre attendus en mars.
EDAP TMS SA (Nasdaq: EDAP), ein führendes Unternehmen im Bereich der robotergestützten energiebasierten Therapien, gab vorläufige Rekordverkäufe für sein Focal One® System im vierten Quartal 2024 bekannt.
Das Unternehmen berichtete von weltweiten Verkaufszahlen von 11 Focal One Systemen, ein Rekord für das vierte Quartal. In den USA erreichten sowohl die Verkäufe der Systeme als auch die Verfahren Rekordhöhen, mit einem Wachstum von 30% im Jahresvergleich bei den Verfahren.
Laut CEO Ryan Rhodes spiegelt die starke Leistung die wachsende Akzeptanz der Focal One Robotic HIFU Technologie wider, die verändert, wie Urologen Prostatakrebs behandeln. Die kürzliche Veröffentlichung der HIFI-Studie in European Urology soll das Bewusstsein und die Akzeptanz weiter steigern.
Mit dem Eintritt in das Jahr 2025 erwartet EDAP ein fortgesetztes Wachstum in der Adoption der Focal One Technologie durch urologische Praxen. Die vorläufigen Daten unterliegen den endgültigen Finanzberichterstattungsprozessen, wobei die endgültigen Q4-Ergebnisse für März erwartet werden.
- Preliminary record sales of 11 Focal One Systems in Q4 2024.
- 30% year-over-year growth in U.S. Focal One procedures.
- Recent HIFI study publication expected to drive further adoption.
- None.
Insights
The record sales performance of 11 Focal One Systems in Q4 2024 marks a pivotal expansion in EDAP's market penetration. The
The robotic HIFU market segment is experiencing rapid growth due to increasing demand for minimally invasive prostate cancer treatments. EDAP's dominant position in this niche, combined with expanding procedure volumes, suggests potential for sustained revenue growth through both system sales and recurring procedure-based revenue streams. The robust sales pipeline mentioned for 2025 indicates strong market momentum and potential for continued quarterly growth.
This preliminary Q4 performance has substantial financial implications. Medical device companies typically generate
For a company with a market cap of
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
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
FAQ
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