WATER III Randomized-Controlled Trial Results Announced at European Association of Urology Comparing Aquablation® Therapy to Laser Enucleation

Rhea-AI Summary

PROCEPT BioRobotics (NASDAQ: PRCT) announced results from the WATER III trial comparing Aquablation therapy to laser enucleation for treating large prostates (80-180mL). The international study, involving 186 men between December 2020 and September 2024, revealed that Aquablation therapy achieved similar symptom relief while demonstrating significantly better outcomes in key areas:

• Lower ejaculatory dysfunction rates (14.8% vs 77.1%)
• Lower stress incontinence rates (0% vs 9.1%)
• 0% procedural transfusion rate

The trial results, presented at the European Association of Urology 2025 Annual Congress in Madrid, add to Aquablation therapy's clinical foundation, which includes the WATER study, WATER II, and over 150 peer-reviewed publications.

Positive

• Demonstrated significantly lower ejaculatory dysfunction rates vs. laser enucleation (14.8% vs 77.1%)
• Achieved 0% stress incontinence rate compared to 9.1% for laser enucleation
• Recorded 0% procedural transfusion rate, indicating strong safety profile
• Delivered equivalent symptom relief compared to established treatment

Negative

• None.

Insights

Urology Medical Expert

The WATER III trial results represent a significant advancement in the BPH treatment landscape. By demonstrating that Aquablation therapy provides comparable symptom relief to laser enucleation while dramatically reducing side effects, PROCEPT has strengthened its clinical position considerably.

What stands out most is the preservation of sexual function with only 14.8% ejaculatory dysfunction versus 77.1% for laser enucleation—a critical difference for patient quality of life. Similarly, the 0% stress incontinence rate (versus 9.1% with laser) addresses one of the most distressing potential complications of prostate procedures.

The 0% transfusion rate effectively counters historical concerns about bleeding risk with Aquablation, demonstrating that modern techniques have successfully addressed this issue. This makes the procedure more appealing to both patients and surgeons who may have been hesitant due to bleeding concerns.

This trial builds strategically on PROCEPT's previous randomized studies (WATER and WATER II), creating a comprehensive evidence base across different prostate sizes. With data now covering prostates from 30mL to 180mL, Aquablation's clinical validation spans virtually the entire spectrum of BPH patients who might require surgical intervention.

Medical Device Market Analyst

PROCEPT's WATER III results deliver exactly what's needed to accelerate Aquablation therapy adoption in the competitive BPH surgical market. The data addresses the critical balance between efficacy and side effects that drives both physician and patient decision-making.

Most BPH treatment options force a tradeoff between symptom relief and quality-of-life preservation. Aquablation's demonstrated ability to deliver comparable efficacy with significantly reduced sexual and continence side effects presents a compelling value proposition that differentiates it from established alternatives.

The study design comparing against laser enucleation—considered by many urologists to be the gold standard for larger prostates—was strategically sound. By benchmarking against a challenging comparator rather than easier alternatives, PROCEPT has generated more credible and persuasive evidence.

The multicenter international design with 186 patients provides robust evidence that will resonate with guidelines committees and key opinion leaders. Additionally, the presentation at EAU's prestigious Game-Changer session maximizes visibility among European urologists, potentially accelerating international adoption.

With this third randomized controlled trial completing PROCEPT's clinical evidence portfolio across all relevant prostate sizes (now 30-180mL), the company has eliminated a significant barrier to broader adoption by surgeons who were waiting for more comprehensive data before incorporating the technology.

Aquablation therapy delivers similar symptom score reduction, superior ejaculatory function preservation, and superior continence preservation to laser enucleation in 80–180 mL prostates in a randomized, multicenter trial

SAN JOSE, Calif., March 24, 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 its Aquablation therapy was evaluated in the independent, investigator-initiated WATER III trial. This study compared Aquablation therapy to laser enucleation for treating large prostates, with results presented in the prestigious Game-Changer session at the European Association of Urology (EAU) 2025 Annual Congress in Madrid, Spain.

WATER III is an international, prospective, multicenter study comparing Aquablation therapy to laser enucleation in prostate sizes 80-180mL. The study treated 186 men between December 2020 and September 2024 and reported three-month primary safety and efficacy endpoints and will subsequently follow patients to five years. The three-month results demonstrated that Aquablation therapy delivered substantially similar symptom relief while showing significantly lower rates of ejaculatory dysfunction (14.8% vs. 77.1%) and stress incontinence (0% vs. 9.1%) compared to laser enucleation.

Additionally, the procedural transfusion rate in the Aquablation therapy arm was 0%. These findings demonstrate that modern Aquablation therapy techniques are both safe and highly reproducible in managing bleeding risk.

"WATER III represents a significant milestone in our mission to establish Aquablation therapy as the standard of care for patients suffering with BPH," said Reza Zadno, CEO of PROCEPT BioRobotics. "Building on our previous randomized WATER data comparing Aquablation therapy to TURP, WATER III demonstrates that Aquablation therapy delivers compelling clinical outcomes compared to laser enucleation. What makes these results particularly meaningful is Aquablation therapy's ability to deliver effective symptom relief while preserving critical quality of life factors—specifically sexual function and continence. These findings reinforce our dedication to providing treatments that address the complete patient experience."

“The WATER III results are impressive, demonstrating that Aquablation therapy can achieve outcomes comparable to laser enucleation.” said Dr. Naeem Bhojani, University of Montreal. “The consistent efficacy coupled with the significantly lower rates of ejaculatory dysfunction and stress incontinence represents a meaningful advancement for patients seeking treatment for BPH. The effectiveness of Aquablation therapy is shown by its ability to achieve similar results as highly skilled and experienced laser enucleation surgeons.”

These results add to Aquablation therapy’s robust clinical foundation, which include the randomized WATER study (Aquablation therapy vs. TURP in 30-80 mL prostates) with five-year results, WATER II (Aquablation therapy in large prostates 80-150 mL) with five-year results, coupled with over 150 peer-reviewed publications. The growing body of clinical evidence, including multiple randomized clinical studies, demonstrate Aquablation therapy is a globally, reproducible procedure with the potential to become the BPH standard of care for all prostate sizes.

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.

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/

Media Contact:
Laurie Vertuccio
Director of Marketing
(781) 888-0439
l.vertuccio@procept-biorobotics.com

Investor Contact:
Matt Bacso
VP, Investor Relations and Business Operations
m.bacso@procept-biorobotics.com

FAQ

What are the key findings of PRCT's WATER III trial for Aquablation therapy?

The trial showed Aquablation therapy achieved similar symptom relief as laser enucleation, with significantly lower rates of ejaculatory dysfunction (14.8% vs 77.1%) and stress incontinence (0% vs 9.1%), plus a 0% transfusion rate.

How many patients were involved in PRCT's WATER III trial and what was the study period?

The study included 186 men and was conducted between December 2020 and September 2024.

What prostate sizes were evaluated in PRCT's WATER III clinical trial?

The trial evaluated prostates ranging from 80-180mL in size.

How does WATER III complement PRCT's existing clinical evidence for Aquablation?

WATER III adds to PRCT's clinical foundation, which includes the WATER study, WATER II with five-year results, and over 150 peer-reviewed publications.