Ambulatory Surgery Center Completes WATER IV Trial Procedures for Prostate Cancer with Aquablation® Therapy

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/

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