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

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