Real-World, Long-Term Data Demonstrate Sustained Benefits of Aquablation Therapy for Men With Benign Prostatic Hyperplasia
Real-World, Long-Term Data Demonstrate Sustained Benefits of Aquablation Therapy for Men With Benign Prostatic Hyperplasia
Data from the Icahn School of Medicine at Mount Sinai and Potomac Urology presented at the 2024 AUA Annual Meeting highlight Aquablation therapy's potential to become the new standard of care in BPH for prostates of all sizes
西奈山伊坎醫學院和波托馬克泌尿外科在2024年AUA年會上公佈的數據突顯了水消融療法有可能成爲各種大小前列腺的良性前列腺新護理標準
SAN JOSE, Calif., May 06, 2024 (GLOBE NEWSWIRE) -- PROCEPT BioRobotics Corporation (Nasdaq: PRCT) (the "Company"), a surgical robotics company focused on advancing patient care by developing transformative solutions in urology, today announced long-term, real-world data showcasing the benefits of Aquablation therapy for the treatment of symptomatic benign prostatic hyperplasia (BPH) at both academic and commercial settings. The results were presented this past weekend at the American Urological Association (AUA) Annual Meeting in San Antonio, Texas.
加利福尼亞州聖何塞，2024 年 5 月 6 日（GLOBE NEWSWIRE）— PROCEPT 生物機器人 公司 納斯達克股票代碼：PRCT）（“公司”）是一家專注於通過開發泌尿外科變革性解決方案來促進患者護理的外科機器人公司。該公司今天公佈了長期的真實數據，展示了Aquablation療法在學術和商業環境中治療有症狀的良性前列腺增生（BPH）的益處。研究結果於上週末在德克薩斯州聖安東尼奧市舉行的美國泌尿外科學會（AUA）年會上公佈。
"The data presented at AUA confirm the safety and long-term durability of Aquablation therapy in treating men with symptomatic benign prostatic hyperplasia, regardless of prostate size or shape," said Reza Zadno, CEO of PROCEPT BioRobotics. "The fact that 12 abstracts were presented this past weekend underscores the growing body of real-world evidence to support that Aquablation therapy delivers the highest standard in urological care."
PROCEPT BioRobotics首席執行官雷扎·扎德諾表示：“AUA提供的數據證實了Aquablation療法在治療有症狀的良性前列腺增生男性方面的安全性和長期耐久性，無論前列腺大小或形狀如何。”“上週末發表了12份摘要，這一事實凸顯了越來越多的現實世界證據支持Aquablation療法提供了泌尿外科護理的最高標準。”
Icahn School of Medicine at Mount Sinai – 4-Year Outcomes
Aquablation therapy was performed on 275 adult men with moderate to severe BPH with a prostate volume between 38 and 293 mL (mean volume of 108.3 mL). The patients were out to 4 years post-procedure.
西奈山伊坎醫學院——四年成果
對275名患有中度至重度良性前列腺增生、前列腺容積在38至293 mL（平均體積爲108.3 mL）之間的成年男性進行了水解消融療法。患者在手術後四年才出院。
Key results:
主要成果：
- Mean prostate volume decreased from 108.3 mL to 66.2 mL (-38.9%).
- International Prostate Symptom Score (IPSS) improved from 24.2 at baseline to 7.1 at 4 years.
- Peak urinary flow rate (Qmax) increased nearly 3-fold from 6.1 mL/sec to 17.1 mL/sec.
- Antegrade ejaculation was preserved for 99% of men.
- Surgical retreatment occurred in 1.8% patients.
- 平均前列腺體積從108.3 mL下降到66.2 mL（-38.9％）。
- 國際前列腺症狀評分（IPSS）從基線的24.2提高到4年的7.1。
- 峯值尿流量（Qmax）增加了近3倍，從6.1毫升/秒增加到17.1毫升/秒。
- 99% 的男性保留了行前射精。
- 手術再治療發生在 1.8% 的患者中。
"BPH is a condition that impacts the majority of men as they age, but treatment options have not historically found the balance between alleviating symptoms from enlarged prostates while preserving sexual function and urinary continence. While there have been studies demonstrating the durable efficacy and safety profile of Aquablation therapy for the treatment of BPH, this is the largest academic single-center experience demonstrating long-term performance in BPH management," said Dr. Steven Kaplan, Icahn School of Medicine at Mount Sinai.
“良性前列腺增生是一種會隨着年齡增長而影響大多數男性的疾病，但是從歷史上看，治療選擇並未在緩解前列腺腫大症狀與保持性功能和尿失禁之間找到平衡。儘管有研究表明Aquablation療法治療良性前列腺增生具有持久的療效和安全性，但這是證明良性前列腺增生長期表現的最大規模的學術單中心經驗。” 西奈山伊坎醫學院的史蒂芬·卡普蘭博士說。
Potomac Urology - Aquablation Case Series of 812 Consecutive Men with LUTS due to BPH
Three surgeons at Potomac Urology collected data on 812 consecutive men treated with Aquablation therapy. Routine procedural characteristics, adverse events, symptom scores and uroflow were collected over 3 years. The data showed that safety has been improved and efficacy was consistent against FDA clinical trials. Day case Aquablation therapy has also been shown to be a viable option.
波托馬克泌尿科——連續812名因良性前列腺增生而患有 LUT 的男性的 Aquablation 案例系列
波托馬克泌尿科的三名外科醫生收集了連續812名接受水消融療法治療的男性的數據。在 3 年內收集了常規手術特徵、不良事件、症狀評分和尿流量。數據顯示，與美國食品藥品管理局的臨床試驗相比，安全性已得到改善，療效一致。日用水消融療法也被證明是一種可行的選擇。
Key results:
主要成果：
- Mean age, IPSS, Qmax and prostate volume were 69 ± 8, 21 ± 7, 11 ± 6, and 77 ml (range 22-263 ml), respectively.
- IPSS at 8, 12, 24 and 36 months was 7 or less.
- 14% of patients were in preoperative retention with 94% of those patients passing their trial of voids.
- Secondary intervention due to recurrent LUTS was 1.6%.
- 平均年齡、IPSS、Qmax和前列腺體積分別爲69±8、21±7、11±6和77 ml（範圍爲22-263 ml）。
- 8、12、24和36個月時的IPSS爲7個月或更短。
- 14% 的患者處於術前滯留狀態，其中 94% 的患者通過了空洞試驗。
- 由複發性LUTS引起的二次干預爲1.6％。
"Aquablation therapy strikes the ideal balance of providing the efficacy and durability of a resective procedure while providing the safety and tolerability of a minimally invasive procedure. We have treated more than 800 men with Aquablation therapy and feel that the results truly speak for themselves," said Shawn Marhamati, MD, MS, at Potomac Urology.
“Aquablation 療法在提供切除手術的療效和耐久性與提供微創手術的安全性和耐受性之間取得了理想的平衡。我們已經使用Aquablation療法治療了800多名男性，他們認爲結果不言自明。” 波托馬克泌尿科醫學博士、多發性硬化症肖恩·馬爾哈馬蒂說。
Registered attendees can access the full list of Aquablation therapy presentations here.
Additional abstract highlights include:
註冊的與會者可以訪問 Aquablation 療法演示的完整列表 這裏。
其他摘要要點包括：
-
MP20-01: WATER vs WATER II 5-Year Update: Comparing Aquablation Therapy for Benign Prostatic Hyperplasia in 30-80 cc and 80-150 cc Prostates
Mohamad Baker Berjaoui, MD
University of Toronto
This study presented the final analysis comparing clinical trial outcomes of Aquablation to TURP for the treatment of lower urinary tract symptoms (LUTS) in small-to-moderate prostates (WATER study: NCT02505919) to those in large prostates (WATER II: NCT03123250) at five-year follow-up. The final analysis of the two, prospective clinical trials demonstrated that Aquablation therapy has durable outcomes and low retreatment rates for the treatment of LUTS/BPH independently of prostate volume between 30-150 ml prostates.
- MP20-01：WATER vs WATER II 5 年更新：比較 30-80 cc 和 80-150 cc 前列腺中良性前列腺增生的水療消融療法
穆罕默德·貝克·伯賈維，醫學博士
多倫多大學
該研究提供了最終分析，將Aquablation與TURP治療中小至中度前列腺的下尿路症狀（LUTS）（WATER研究：NCT02505919）的臨床試驗結果與大前列腺（WATER II：NCT03123250）在五年隨訪中的臨床試驗結果進行了比較。對這兩項前瞻性臨床試驗的最終分析表明，Aquablation療法無論前列腺容量在30-150 ml前列腺體積如何，治療LUTS/BPH都具有持久的療效和較低的再治療率。
-
MP: 20-03: Aquablation Real-World Prostate Size Utilization and Reported Bleeding Events Across 5 Years
Dean Elterman, MD, MSc, FRCSC
University of Toronto
While clinical studies in the past have evaluated Aquablation therapy's application in glands between 30-150 mL, this study sought to evaluate how the technology is used in the real-world setting. 31,944 procedures were evaluated from 2019-2023 in patients across Asia, Europe and North America. Aquablation showed a consistent adoption in use across a broad range prostates sizes over five years with a very low risk of bleeding.
- MP：20-03：Aquablation 真實世界前列腺大小利用率和5年內報告的出血事件
迪恩·埃爾特曼，醫學博士，理學碩士，FRCSC
多倫多大學
儘管過去的臨床研究評估了Aquablation療法在30-150 mL腺體中的應用，但該研究旨在評估該技術在現實環境中的使用情況。從2019-2023年起，對亞洲、歐洲和北美患者進行了31,944例手術評估。Aquablation顯示，五年來在各種大小的前列腺中均得到持續採用，出血風險非常低。
-
MP20-05: Day Case Aquablation: First Published Experience Report in an Ambulatory Surgical Center (ASC)
Kevin C. Zorn, MD, FACS, FRCSC
BPH Canada Prostate Surgery Institute
The study investigated the feasibility, safety and efficacy of same day discharge (SDD) after Aquablation specifically in an ASC. Results showed that same day discharge after Aquablation therapy for BPH at an ASC appears to be a safe and effective approach, yielding favorable outcomes in terms of symptom relief and patient satisfaction.
- MP20-05：日間病例Aquablation：門診外科中心（ASC）首次發佈的經驗報告
凱文·佐恩，醫學博士，FACS，FRCSC
BPH 加拿大前列腺外科研究所
該研究調查了水消融後當日出院（SDD）的可行性、安全性和有效性，特別是在ASC中。結果顯示，在ASC接受BPH的Aquablation治療後當天出院似乎是一種安全有效的方法，在症狀緩解和患者滿意度方面取得了良好的結果。
For more information on Aquablation therapy, please visit www.procept-biorobotics.com/aua2024/.
有關 Aquablation 療法的更多信息，請訪問 www.procept-biorobotics.com/aua2024/。
About Aquablation Therapy
Aquablation therapy is the first and only ultrasound guided, robotic-assisted, heat-free waterjet for the treatment of BPH. The system's real-time ultrasound imaging provides the surgeon with a multi-dimensional view of the prostate enabling personalized treatment planning tailored to each patient's unique anatomy. The surgeon can specify which areas of the prostate to remove while preserving the anatomy that controls erectile function, ejaculatory function and continence. Once the treatment plan is mapped by the surgeon, the predictable robotic-assisted execution enables prostate tissue to be removed in a precise, targeted, and controlled fashion.
關於水消融療法
Aquablation 療法是第一種也是唯一一種用於治療良性前列腺增生的超聲引導、機器人輔助的無熱水射流療法。該系統的實時超聲成像爲外科醫生提供了前列腺的多維視圖，從而可以根據每位患者的獨特解剖結構量身定製個性化治療計劃。外科醫生可以指定要切除前列腺的哪些區域，同時保留控制勃起功能、射精功能和尿失禁的解剖結構。一旦外科醫生制定了治療計劃，可預測的機器人輔助執行就可以以精確、有針對性和可控的方式切除前列腺組織。
About PROCEPT BioRobotics Corporation
PROCEPT BioRobotics is a surgical robotics company focused on advancing patient care by developing transformative solutions in urology. PROCEPT BioRobotics develops, manufactures and sells the AquaBeam Robotic System, an advanced, image-guided, surgical robotic system for use in minimally invasive urologic surgery with an initial focus on treating benign prostatic hyperplasia, or BPH. BPH is the most common prostate disease and impacts approximately 40 million men in the United States. PROCEPT BioRobotics designed Aquablation therapy to deliver effective, safe and durable outcomes for males suffering from lower urinary tract symptoms, or LUTS, due to BPH that are independent of prostate size and shape or surgeon experience. The Company has developed a significant and growing body of clinical evidence, which includes nine clinical studies and over 150 peer-reviewed publications, supporting the benefits and clinical advantages of Aquablation therapy.
關於 PROCEPT BioRobotics 公司
PROCEPT BioRobotics是一家手術機器人公司，致力於通過開發泌尿科變革性解決方案來促進患者護理。PROCEPT BioRobotics開發、製造和銷售AquaBeam機器人系統，這是一種先進的圖像引導手術機器人系統，用於微創泌尿外科手術，最初的重點是治療良性前列腺增生（BPH）。良性前列腺增生是最常見的前列腺疾病，在美國影響約4000萬男性。PROCEPT BioRobotics 設計的水消融療法旨在爲因良性前列腺增生引起的下尿路症狀或 LUTS 的男性提供有效、安全和持久的療效，這些症狀與前列腺大小和形狀或外科醫生的經驗無關。該公司已經開發了大量且不斷增長的臨床證據，其中包括九項臨床研究和150多份經過同行評審的出版物，這些證據支持了Aquablation療法的益處和臨床優勢。
Forward-Looking Statements
This release contains forward-looking statements within the meaning of federal securities laws, including with respect to the Company's projected financial performance for full year 2024, statements regarding the potential utilities, values, benefits and advantages of Aquablation therapy performed using PROCEPT BioRobotics' products, including AquaBeam Robotic System, which involve risks and uncertainties that could cause the actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. You are cautioned not to place undue reliance on these forward-looking statements. Forward-looking statements are only predictions based on our current expectations, estimates, and assumptions, valid only as of the date they are made, and subject to risks and uncertainties, some of which we are not currently aware. Forward-looking statements may include statements regarding financial guidance, market opportunity and penetration, the Company's possible or assumed future results of operations, including descriptions of the Company's revenues, gross margin, profitability, operating expenses, installed base growth, commercial momentum, reimbursement coverage, overall business strategy, or information regarding the impact of other global events on the Company and its operations. Forward-looking statements should not be read as a guarantee of future performance or results and may not necessarily be accurate indications of the times at, or by, which such performance or results will be achieved. These forward-looking statements are based on the Company's current expectations and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties. These risks and uncertainties are described more fully in the section titled "Risk Factors" in the Company's filings with the Securities and Exchange Commission (the "SEC"), including the Company's annual report on Form 10-K expected to be filed with the SEC on or about February 28, 2024. PROCEPT BioRobotics does not undertake any obligation to update forward-looking statements and expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein. These forward-looking statements should not be relied upon as representing PROCEPT BioRobotics' views as of any date subsequent to the date of this press release.
前瞻性陳述
本新聞稿包含聯邦證券法所指的前瞻性陳述，包括有關公司2024年全年預計財務業績的前瞻性陳述，有關Aquablation潛在效用、價值、收益和優勢的陳述 使用 PROCEPT BioRobotics 的產品進行治療，包括 AquaBeam 機器人系統，其中涉及風險和不確定性，可能導致實際結果與這些前瞻性陳述中表達的預期結果和預期存在重大差異。提醒您不要過分依賴這些前瞻性陳述。前瞻性陳述僅是基於我們當前的預期、估計和假設的預測，僅在發表之日有效，並受風險和不確定性的影響，其中一些我們目前尚不知道。前瞻性陳述可能包括有關財務指導、市場機會和滲透率、公司可能或假設的未來經營業績的陳述，包括對公司收入、毛利率、盈利能力、運營支出、裝機量增長、商業勢頭、報銷範圍、總體業務戰略的描述，或有關其他全球事件對公司及其運營的影響的信息。前瞻性陳述不應被視爲對未來業績或業績的保證，也不一定能準確地表明在何時或之前實現此類業績或業績。這些前瞻性陳述基於公司當前的預期，本質上涉及重大風險和不確定性。由於這些風險和不確定性，實際結果和事件發生時間可能與此類前瞻性陳述中的預期存在重大差異。公司向美國證券交易委員會（“SEC”）提交的文件中標題爲 “風險因素” 的部分對這些風險和不確定性進行了更全面的描述，其中包括預計將於2024年2月28日左右向美國證券交易委員會提交的公司10-K表年度報告。PROCEPT BioRobotics不承擔任何更新前瞻性陳述的義務，並明確表示不承擔任何義務或承諾公開發布此處包含的任何前瞻性陳述的任何更新或修訂。不應將這些前瞻性陳述視爲本新聞稿發佈之日後任何日期的PROCEPT BioRobotics的觀點。
Important Safety Information
All surgical treatments have inherent and associated side effects. For a list of potential side effects visit https://aquablation.com/safety-information/.
重要安全信息
所有手術治療都有固有的和相關的副作用。有關潛在副作用的清單，請訪問 https://aquablation.com/safety-information/。
Media Contact:
Lauren Cohen
Senior Director, Integrated Marketing and Communications
l.cohen@procept-biorobotics.com
媒體聯繫人：
勞倫·科恩
整合營銷與傳播高級董事
l.cohen@procept-biorobotics.com
Investor Contact:
Matt Bacso
VP, Investor Relations and Business Operations
m.bacso@procept-biorobotics.com
投資者聯繫人：
Matt Bacso
投資者關係和業務運營副總裁
m.bacso@procept-biorobotics.com
譯文內容由第三人軟體翻譯。