Ambulatory Surgery Center Completes WATER IV Trial Procedures for Prostate Cancer with Aquablation® Therapy
PROCEPT BioRobotics (Nasdaq: PRCT) announced a significant milestone in its WATER IV Prostate Cancer Trial, with three successful prostate cancer procedures completed at an Ambulatory Surgery Center (ASC) using Aquablation® therapy. The procedures were performed by Dr. Rahul Mehan in Scottsdale, Arizona.
The FDA-approved IDE clinical study aims to compare Aquablation® therapy with radical prostatectomy for treating localized prostate cancer (Grade Group 1 to 3). Aquablation therapy utilizes a robotically-controlled waterjet for targeted prostate tissue removal, while radical prostatectomy involves complete prostate removal.
This milestone demonstrates the potential for treating early-stage prostate cancer in an ASC setting, suggesting a more scalable and cost-effective care model for prostate cancer treatment.
PROCEPT BioRobotics (Nasdaq: PRCT) ha annunciato un traguardo importante nel suo studio WATER IV sul cancro alla prostata, con tre procedure di successo per il cancro alla prostata eseguite in un Ambulatory Surgery Center (ASC) utilizzando la terapia Aquablation®. Le procedure sono state eseguite dal dott. Rahul Mehan a Scottsdale, Arizona.
Lo studio clinico IDE approvato dalla FDA mira a confrontare la terapia Aquablation® con la prostatectomia radicale per il trattamento del cancro alla prostata localizzato (Gruppo di Grado 1 a 3). La terapia Aquablation utilizza un getto d'acqua controllato roboticamente per rimuovere il tessuto prostatico in modo mirato, mentre la prostatectomia radicale comporta la rimozione completa della prostata.
Questo traguardo dimostra il potenziale per trattare il cancro alla prostata in fase iniziale in un ambiente ASC, suggerendo un modello di cura più scalabile ed economico per il trattamento del cancro alla prostata.
PROCEPT BioRobotics (Nasdaq: PRCT) anunció un hito significativo en su ensayo WATER IV para el cáncer de próstata, con tres procedimientos exitosos de cáncer de próstata realizados en un Centro de Cirugía Ambulatoria (ASC) utilizando la terapia Aquablation®. Los procedimientos fueron realizados por el Dr. Rahul Mehan en Scottsdale, Arizona.
El estudio clínico IDE aprobado por la FDA tiene como objetivo comparar la terapia Aquablation® con la prostatectomía radical para el tratamiento del cáncer de próstata localizado (Grupo de Grado 1 a 3). La terapia Aquablation utiliza un chorro de agua controlado por robot para la eliminación dirigida del tejido prostático, mientras que la prostatectomía radical implica la extirpación completa de la próstata.
Este hito demuestra el potencial para tratar el cáncer de próstata en etapa temprana en un entorno ASC, sugiriendo un modelo de atención más escalable y rentable para el tratamiento del cáncer de próstata.
PROCEPT BioRobotics (나스닥: PRCT)는 WATER IV 전립선암 임상시험에서 중요한 이정표를 발표했습니다. 세 건의 성공적인 전립선암 시술이 Ambulatory Surgery Center(ASC)에서 Aquablation® 치료를 사용해 완료되었습니다. 이 시술은 애리조나주 스코츠데일의 Rahul Mehan 박사가 수행했습니다.
FDA 승인 IDE 임상 연구는 국소 전립선암(1~3단계 등급 그룹) 치료를 위해 Aquablation® 치료와 근치적 전립선 절제술을 비교하는 것을 목표로 합니다. Aquablation 치료는 로봇 제어 수류를 이용해 표적 전립선 조직을 제거하는 반면, 근치적 전립선 절제술은 전립선을 완전히 제거합니다.
이번 이정표는 ASC 환경에서 초기 전립선암 치료 가능성을 보여주며, 전립선암 치료를 위한 보다 확장 가능하고 비용 효율적인 치료 모델을 제시합니다.
PROCEPT BioRobotics (Nasdaq : PRCT) a annoncé une étape importante dans son essai WATER IV sur le cancer de la prostate, avec trois procédures réussies de cancer de la prostate réalisées dans un centre de chirurgie ambulatoire (ASC) utilisant la thérapie Aquablation®. Les procédures ont été effectuées par le Dr Rahul Mehan à Scottsdale, en Arizona.
L'étude clinique IDE approuvée par la FDA vise à comparer la thérapie Aquablation® à la prostatectomie radicale pour le traitement du cancer localisé de la prostate (groupe de grade 1 à 3). La thérapie Aquablation utilise un jet d'eau contrôlé par robot pour retirer de manière ciblée le tissu prostatique, tandis que la prostatectomie radicale consiste en l'ablation complète de la prostate.
Cette étape démontre le potentiel de traitement du cancer de la prostate à un stade précoce dans un cadre ASC, suggérant un modèle de soins plus évolutif et rentable pour le traitement du cancer de la prostate.
PROCEPT BioRobotics (Nasdaq: PRCT) gab einen bedeutenden Meilenstein in seiner WATER IV Prostatakrebs-Studie bekannt, mit drei erfolgreichen Prostatakrebs-Verfahren, die in einem ambulanten Operationszentrum (ASC) unter Verwendung der Aquablation®-Therapie durchgeführt wurden. Die Eingriffe wurden von Dr. Rahul Mehan in Scottsdale, Arizona, vorgenommen.
Die FDA-zugelassene IDE-Studie hat zum Ziel, die Aquablation®-Therapie mit der radikalen Prostatektomie bei der Behandlung von lokalisiertem Prostatakrebs (Gradgruppe 1 bis 3) zu vergleichen. Die Aquablation-Therapie nutzt einen robotergesteuerten Wasserstrahl zur gezielten Entfernung von Prostatagewebe, während die radikale Prostatektomie die vollständige Entfernung der Prostata beinhaltet.
Dieser Meilenstein zeigt das Potenzial, Prostatakrebs im Frühstadium in einem ASC-Umfeld zu behandeln, und deutet auf ein skalierbares und kosteneffizientes Versorgungsmodell für die Behandlung von Prostatakrebs hin.
- Successful completion of three prostate cancer procedures in ASC setting using Aquablation therapy
- FDA approval for IDE clinical study comparing Aquablation therapy to radical prostatectomy
- Demonstration of same-day discharge capability without complications
- Potential for more cost-effective treatment model in ASC setting
- Study results are still pending and efficacy comparison with radical prostatectomy is unknown
- Limited to early-stage prostate cancer cases (Grade Group 1 to 3)
Insights
PROCEPT's WATER IV trial milestone shows Aquablation's potential for outpatient prostate cancer treatment, promising cost advantages and market expansion.
PROCEPT BioRobotics has reached a significant milestone in its WATER IV clinical trial, successfully completing three prostate cancer procedures in an Ambulatory Surgery Center (ASC) setting using its Aquablation therapy. This achievement demonstrates that early-stage prostate cancer can be treated safely in an outpatient environment using their robotic waterjet technology.
The WATER IV trial is comparing Aquablation therapy to radical prostatectomy for treating localized prostate cancer (Grade Group 1-3). What makes this development particularly noteworthy is the care delivery model innovation - traditional radical prostatectomy typically requires hospital admission, while these Aquablation procedures were completed with same-day discharge and no complications.
This has substantial implications for both clinical practice and PROCEPT's business model. The ability to perform these procedures in ASCs creates a more scalable, cost-effective care pathway compared to hospital-based treatments. For patients, this could mean reduced costs, faster recovery, and less healthcare system burden.
The technology aims to thread the needle between aggressive whole-gland removal (radical prostatectomy) and more conservative focal therapies by resecting diagnosed cancer and most of the prostate while potentially preserving function. If successful, Aquablation could position itself as an attractive middle-ground option in the prostate cancer treatment spectrum.
While still in the investigational stage with the trial ongoing, the endorsement from Dr. Gill (a prominent figure in urology) signals potential for practice-changing impact if the trial demonstrates comparable efficacy with improved side effect profiles compared to radical prostatectomy. This could substantially expand PROCEPT's addressable market from just BPH into the much larger prostate cancer treatment space.
SAN JOSE, Calif., July 23, 2025 (GLOBE NEWSWIRE) -- PROCEPT BioRobotics® Corporation (Nasdaq: PRCT) (the “Company”), a surgical robotics company dedicated to advancing patient care through transformative urology solutions, today announced that three prostate cancer procedures in the WATER IV Prostate Cancer (PCa) Trial were successfully completed in an Ambulatory Surgery Center (ASC) using Aquablation® therapy by Dr. Rahul Mehan of East Valley Urology in Scottsdale, Arizona.
WATER IV PCa is a U.S. FDA investigational device exemption (IDE) approved clinical study comparing Aquablation® therapy and radical prostatectomy for the treatment of localized prostate cancer. The study will evaluate and compare the safety and efficacy of Aquablation therapy and radical prostatectomy for men with Grade Group 1 to 3 localized prostate cancer. Aquablation therapy is an image-guided, minimally invasive surgery that aims to resect (remove) diagnosed cancer and most of the prostate using a robotically-controlled waterjet. Radical prostatectomy is a traditional surgery that removes the entire prostate along with some surrounding tissue. A surgical robot is often used to perform the radical prostatectomy surgery.
“While most WATER IV PCa trial sites will treat patients in a hospital setting, Dr. Mehan has elected to treat his randomized Aquablation therapy trial patients at an ASC,” said Barry Templin, chief technology officer of PROCEPT BioRobotics. “This announcement marks a major milestone: we have demonstrated early-stage prostate cancer can be safely treated at an ASC with Aquablation therapy. With a prostate cancer treatment approach that removes significantly more tissue than a typical BPH procedure or focal therapy, Dr. Mehan successfully completed all procedures and discharged patients the same day without complications. This is indicative of not only a safe prostate resection, but also the potential for a more scalable, cost-effective care model in a rapidly changing market.”
“WATER IV PCa, a unique and thoughtful randomized trial design focusing on harm reduction by using Aquablation therapy as first line treatment in comparison to radical prostatectomy for men with Grade Group 1 to 3 localized prostate cancer, could potentially change the way urologists treat localized prostate cancer for millions of men,” said, Inderbir Gill, MD, Global co-PI of the WATER IV trial and founding executive director of USC Institute of Urology, part of Keck Medicine of USC and chairman, Catherine & Joseph Aresty Department of Urology, Keck School of Medicine of USC. “It is exciting to see that the FDA approved this IDE after a prompt and thorough review of the trial design, and we look forward to seeing the results of our forthcoming trial and are hopeful about the possibilities of this novel treatment approach for the most commonly diagnosed internal cancer in men.”
About Aquablation Therapy
Aquablation therapy is the first and only ultrasound guided, robotic-assisted, heat-free waterjet for the treatment of benign prostatic hyperplasia (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.
About PROCEPT BioRobotics Corporation
PROCEPT BioRobotics is a surgical robotics company focused on advancing patient care by developing transformative solutions in urology. PROCEPT BioRobotics manufactures the AQUABEAM® and HYDROS™ Robotic Systems. The HYDROS Robotic System is the only AI-powered, robotic technology that delivers Aquablation therapy. 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. BPH is the most common prostate disease and impacts approximately 40 million men in the United States. The Company has developed a significant and growing body of clinical evidence with over 150 peer-reviewed publications, supporting the benefits and clinical advantages of Aquablation therapy.
Forward-Looking Statements
This press release may contain forward-looking statements within the meaning of federal securities laws. Forward-looking statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from those anticipated or implied in such statements. PROCEPT BioRobotics undertakes no obligation to publicly update or revise any forward-looking statements.
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/
Investor Contact:
Matt Bacso
VP, Investor Relations and Business Operations
m.bacso@procept-biorobotics.com
FAQ
What is the WATER IV Trial for PRCT's Aquablation therapy?
How does PRCT's Aquablation therapy differ from radical prostatectomy?
What milestone did PROCEPT BioRobotics (PRCT) achieve in the ASC setting?
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What types of prostate cancer cases are eligible for PRCT's WATER IV trial?
