Landmark HIFI Study Publication Demonstrates Positive Outcomes With Focal One Robotic HIFU Versus Surgery in the Management of Prostate Cancer
Landmark HIFI Study Publication Demonstrates Positive Outcomes With Focal One Robotic HIFU Versus Surgery in the Management of Prostate Cancer
HIFI Study is the largest (N = 3,328) prospective, comparative, multi-center clinical study ever conducted comparing prostate cancer treatments
Positive study results are expected to drive further adoption of Focal One as a first line treatment option for the management of localized prostate cancer
Study shows Focal One Robotic HIFU is non-inferior to surgery, meeting primary endpoint of non-inferiority for Salvage Treatment-free Survival (STFS) after High Intensity Focused Ultrasounds (HIFU) compared to Radical Prostatectomy (RP) at 30 months
Study shows that patients receiving HIFU had better outcomes with respect to urinary continence and erectile function compared to patients receiving RP
HIFI研究是迄今爲止最大的(N = 3,328)前瞻性、比較性、多中心臨牀研究,比較前列腺癌治療。
積極的研究結果預計將推動Focal One作爲局部前列腺癌管理的一線治療選擇的進一步採用。
研究顯示,Focal One 機器人HIFU在對比30個月後的救助治療免生存期(STFS)方面不劣於手術,滿足了非劣性主要終點與根治性前列腺切除術(RP)比較。
研究表明,接受HIFU的患者在尿失禁和勃起功能方面的結果優於接受RP的患者。
LYON, France, December 4, 2024 - EDAP TMS SA (Nasdaq: EDAP), the global leader in robotic energy-based therapies, today announced the publication of the full results from the HIFI study in the prestigious, peer-reviewed journal, European Urology, which has the highest impact factor amongst scientific journals focused in urology. The study evaluated HIFU versus radical prostatectomy (RP) as a first line treatment of localized prostate cancer. The paper is entitled "Whole-gland or Subtotal High-intensity Focused Ultrasound Versus Radical Prostatectomy: The Prospective, Noninferiority, Nonrandomized, HIFI Trial" and is authored by Dr. Guillaume Ploussard from Department of Urology, UROSUD, Clinique La Croix du Sud, France. A link to the publication can be found here.
法國里昂,2024年12月4日 - EDAP TMS SA(納斯達克:EDAP),全球機器人能源治療的領導者,今天宣佈在著名的同行評審期刊《歐洲泌尿學》中發表HIFI研究的完整結果,該期刊在關注泌尿學的科學期刊中擁有最高的影響因數。該研究評估了HIFU與根治性前列腺切除術(RP)作爲局部前列腺癌的一線治療。論文題目爲《整體腺體或部分高強度聚焦超聲與根治性前列腺切除術的前瞻性、非劣性、非隨機HIFI試驗》,作者爲法國南部醫院(Clinique La Croix du Sud)泌尿科的Dr. Guillaume Ploussard。可以在此找到出版物的鏈接。
"The publication of the HIFI study in European Urology will importantly serve to increase awareness amongst the global urology and patient community on how robotic HIFU technology is rapidly changing the treatment paradigm for patients with localized, early-stage prostate cancer," said Professor Pascal Rischmann, Principal Investigator of the HIFI trial and senior author of the publication. "It is clear that a growing number of men with localized prostate cancer are seeking less invasive, tissue-sparing treatment options that will help preserve their sexual function and urinary continence. The data from the HIFI Study not only underscores HIFU's excellent oncologic control, but also highlights its significantly better functional outcomes when compared to radical prostatectomy."
「HIFI研究在《歐洲泌尿學》上的發表將重要地提高全球泌尿科和患者社區對機器人HIFU技術如何迅速改變局部早期前列腺癌患者治療範式的認識,」HIFI試驗的主要研究者及出版物的高級作者Pascal Rischmann教授說。「顯然,越來越多的局部前列腺癌患者正在尋求更具侵入性、保護組織的治療選擇,以幫助保留他們的性功能和尿失禁。HIFI研究的數據不僅強調了HIFU的優秀腫瘤控制能力,而且突顯了其相比根治性前列腺切除術的顯著更好的功能結果。」
"We are pleased to announce the publication of the HIFI study results in the prestigious medical journal, European Urology," said Ryan Rhodes, Chief Executive Officer of EDAP TMS. "As the single largest and most rigorous clinical study ever conducted comparing oncologic and functional outcomes between Focal One robotic HIFU and radical prostatectomy, the publication of this data highlights the substantial clinical benefits of Focal One as an important, first line treatment option for the management of localized prostate cancer. We believe the publication of such important, positive results will provide additional momentum to growing Focal One adoption, while further advancing treatment decision guidelines."
"我們高興地宣佈《歐洲泌尿學》這本享有盛名的醫療期刊上發表了HIFI研究結果," EDAP TMS首席執行官Ryan Rhodes表示。"這是迄今爲止規模最大、研究最嚴格的臨牀研究,比較了Focal One機器人HIFU與根治性前列腺切除術之間的腫瘤學和功能結果,該數據的發表突出顯示了Focal One作爲局部前列腺癌管理的重要一線治療選項的顯著臨牀益處。我們相信,這樣重要的積極結果的發表將爲Focal One的推廣提供額外的動力,同時進一步推動治療決策指南的發展。"
HIFI is the first prospective, multi-center, non-inferiority comparative study evaluating HIFU and RP in the management of localized prostate cancer. This seven-year study (April 2015 - March 2022) enrolled a total of 3,328 patients from 46 treatment centers: 1,967 consecutive patients were treated with EDAP's robotic HIFU technologies, where Focal One was used for 90% of the patients, and 1,361 patients underwent radical prostatectomy surgery. All patients were followed for 30 months.
HIFI是首個前瞻性、多中心、非劣性比較研究,評估HIFU和RP在局部前列腺癌管理中的效果。這項爲期七年的研究(2015年4月 - 2022年3月)共納入了來自46個治療中心的3,328名患者:1,967名連續患者接受了EDAP的機器人HIFU技術治療,其中90%的患者使用了Focal One,1,361名患者接受了根治性前列腺切除術。所有患者都進行了30個月的隨訪。
Clinical Data Highlights:
臨牀數據亮點:
At 30 months, the adjusted STFS was higher in the HIFU arm (90%) compared with RP arm (86%)
The propensity score-adjusted result is similar to the univariate result (HR=0.71 [95%CI, 0.52-0.97], p=0.008). After adjustment on different variables (Age, BMI, ASA score, Grade Group, prostate volume, PSA): the risk of salvage treatment is lower in the HIFU arm compared to RP. This result remains true when analyzing the subgroup with intermediate risk (HR=0.66 [95%CI, 0.50-0.86], p=0.001).
International Continence Society (ICS) score, a measure of stress urinary incontinence was significantly less deteriorated for HIFU (29%) vs, RP (44%) (RR=0.66 [95%CI, 0.59-0.74], p<0.001) for all ages combined.
International Index of Erectile Function-5 (IIEF-5), a well validated measurement of erectile function, decreased significantly less after HIFU than after RP with a drop in difference in medians from -9 (-10;-7.7) to -3.0 (-3.9; -2.1) between both groups, for all ages included.
Post-procedural benefits of HIFU on both erectile function and urinary continence were demonstrated despite patients in the HIFU-treated group being an average of 9.6 years older (median age was 74.7 years for HIFU vs 65.1 years for RP, p<0.001)
在30個月時,HIFU組的校正STFS高於RP組(90%對86%)
傾向性得分校正結果與單變量結果相似(HR=0.71 [95%CI, 0.52-0.97], p=0.008)。在不同變量(年齡、BMI、ASA評分、年級組、前列腺容量、PSA)上進行調整後,HIFU組的救治風險低於RP組。當分析中等風險亞組時,這一結果依然成立(HR=0.66 [95%CI, 0.50-0.86], p=0.001)。
國際尿失禁協會(ICS)評分,作爲壓力性尿失禁的衡量指標,HIFU組(29%)的惡化顯著低於RP組(44%)(RR=0.66 [95%CI, 0.59-0.74], p
國際勃起功能指數-5(IIEF-5),作爲勃起功能的有效測量指標,HIFU後下降顯著少於RP,兩個組之間中位數差異從-9(-10;-7.7)減少到-3.0(-3.9; -2.1),適用於所有年齡段。
儘管HIFU治療組的患者平均年齡大於9.6歲(HIFU組中位年齡爲74.7歲,RP組爲65.1歲,p
About European Urology
關於歐洲泌尿學
European Urology is the official journal of the European Association of Urology (EAU). European Urology publishes peer-reviewed original articles and topical reviews on a wide range of urological problems. Topics such as oncology, impotence, infertility, pediatrics, lithiasis and endourology, as well as recent advances in techniques, instrumentation, surgery and pediatric urology provide readers with a complete guide to international developments in urology. Published monthly, European Urology is an important journal for all clinicians and researchers in this field. The 2023 Impact Factor of European Urology is 25.3, the highest impact factor of all urology-focused scientific journals.
《歐洲泌尿學》是歐洲泌尿學會(EAU)官方期刊。《歐洲泌尿學》發表經過同行評審的原創文章和關於各種泌尿問題的專題評述。涉及腫瘤學、陽痿、不孕症、兒科、結石和內窺泌尿學等話題,以及技術、儀器、手術和兒科泌尿學的最新進展,爲讀者提供了有關泌尿學國際發展的完整指南。《歐洲泌尿學》每月出版,是該領域所有臨牀醫生和研究者的重要期刊。2023年《歐洲泌尿學》的影響因數爲25.3,是所有以泌尿學爲重點的科學期刊中影響因數最高的。
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 , us.hifu-prostate.com and .
關於EDAP TMS SA
EDAP TMS是全球治療性超聲市場中的知名領導者,開發,製造,推廣並在全球範圍內分銷使用超聲技術的各種病理的微創醫療設備。通過將最新的成像和治療模式技術結合在其完整的機器人HIFU設備系列中,EDAP TMS推出了Focal One,並將其作爲理想的前列腺組織消融技術在歐洲和美國應用。通過增加ExactVu微型超聲設備,EDAP TMS現在是唯一一家提供從診斷到前列腺癌局部治療的完整解決方案的公司。EDAP TMS還生產和分銷其他醫療設備,包括Sonolith i-move碎石機以及使用體外震波碎石療法(ESWL)處理尿路結石的激光器。有關本公司的更多信息,請訪問「http://www.edap-tms.com」、「us.hifu-prostate.com」、「www.focalone.com」。
作爲機器人能源治療的公認領導者,EDAP TMS開發、製造、推廣並在全球範圍內分銷用於多種病症的微創醫療設備,使用超聲技術。通過將最新的成像、機器人技術和精確的非侵入性能量傳遞相結合,EDAP TMS在歐洲和美國推出了Focal One,作爲泌尿科醫生控制的領先前列腺局部治療,具有擴展到前列腺癌以外的多種適應症的潛力。有關公司的更多信息,請訪問us.hifu-prostate.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.
前瞻性聲明
除了歷史信息,此新聞稿還包含適用聯邦證券法律下的前瞻性聲明,包括 1933 年美國證券法第 27A 節("證券法")或 1934 年美國證券交易法第 21E 節的意義,這些聲明可以通過諸如 "相信"、"可以"、"考慮"、"能否"、"計劃"、"打算"、"旨在"、"可能"、"或許"、"潛在"、"目標"、"標的"、"項目"、"預測"、"預期"、"雄心"、"指導方針"、"應該"、"將"、"估計"、"期望" 和 "預期" 等詞彙或者這些詞的否定及類似表達來識別,它們反映了我們對未來事件和財務業績的看法。這些聲明是基於管理層當前的期望,受多種風險和不確定性的影響,包括我們尚未知曉或當前未被視爲重要的事項,並且無法保證預期事件會發生或設定的目標將實際實現。可能導致實際結果與前瞻性聲明中預期結果顯著不同的重要因素包括,除了其他因素外,我們 HIFU 設備的臨牀狀態和市場接受度,以及我們的碎石和分銷部門的持續市場潛力,以及與當前全球通貨膨脹環境、全球經濟、政治和金融環境的不確定性、地緣政治不穩定、氣候變化和新冠疫情或其他公共衛生危機相關的風險,以及它們對我們的業務運營的影響,包括對我們業務或設備和服務需求的影響。
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.
該公司在提交給證券交易委員會的文件中描述的其他可能導致差異的因素。
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.
前瞻性聲明僅基於當時可獲得的信息,假設和估計。除非法律要求,我們不會根據新信息或未來發展進行更新。雖然我們認爲這些聲明的基礎是我們在此期間獲得的可靠信息,但此類信息可能是有限或不完整的。
Company Contact
Blandine Confort
Investor Relations / Legal Affairs
EDAP TMS SA
+33 4 72 15 31 50
bconfort@edap-tms.com
公司聯繫人
布蘭迪娜·孔福特
投資者關係 / 法律事務
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
投資者聯繫
約翰·弗朗西斯
生命科學顧問公司
(917) 355-2395
jfraunces@lifesciadvisors.com
Source: EDAP TMS S.A.
來源:EDAP TMS S.A.
譯文內容由第三人軟體翻譯。