Study Confirms Safety, Durability of PROCEPT BioRobotics’ Aquablation Therapy in Large Prostates at Two Years

WATER II results published in the Canadian Journal of Urology

REDWOOD CITY, Calif.--(BUSINESS WIRE)-- PROCEPT BioRobotics Corporation, a surgical robotics company developing intelligent solutions to transform the field of urology, has announced that results of the WATER II study demonstrate its Aquablation^® therapy is safe and durable in large prostates (80-150 cc) at two years. Aquablation therapy is a procedure for the treatment of benign prostatic hyperplasia (BPH), and is performed by the AquaBeam^® Robotic System, the first FDA-cleared, automated surgical robot for the treatment of this common condition.

“Until now, there were limited transurethral treatment options for patients with large prostates. Aquablation therapy offers patients a minimally invasive option that enables both durable symptom relief and low rates of side effects, regardless of their prostate size and anatomy,” said study Co-Principal Investigator Mihir Desai, MD, at Keck Hospital, University of Southern California. “In addition, two-year WATER II data confirm that Aquablation therapy provides considerable operating time efficiencies and durable, consistent outcomes with a low learning curve.”

WATER II (Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue) was a prospective multicenter international clinical trial evaluating Aquablation therapy in 101 men with large prostates 80 to 150 cc in size. Two-year follow-up data confirmed that Aquablation is a safe procedure with durable efficacy and a low occurrence of retreatment. The study, published in the Canadian Journal of Urology, demonstrated sustained improvements at 24 months in symptom relief and peak urinary flow rates, while preserving sexual function and urinary continence.

“The AquaBeam Robotic System is the only solution that can consistently and reproducibly treat all prostate sizes,” said Reza Zadno, president and chief executive officer of PROCEPT BioRobotics. “The two-year data from the WATER II study mark a significant milestone, as these results add to the strong body of evidence in support of Aquablation therapy as a safe, durable treatment option for a wide range of BPH patients.”

About PROCEPT BioRobotics Corporation

PROCEPT BioRobotics is a surgical robotics company enabling better patient care by developing transformative solutions in urology. With an initial focus on BPH, the AquaBeam Robotic System delivering Aquablation therapy is the first FDA-cleared, automated surgical robot for the treatment of lower urinary tract symptoms due to BPH. Aquablation therapy combines real-time, multi-dimensional imaging, automated robotics and heat-free waterjet ablation for targeted, controlled, and immediate removal of prostate tissue. Aquablation therapy offers predictable and reproducible outcomes, independent of prostate anatomy, prostate size or surgeon experience. For more information visit https://www.procept-biorobotics.com.

Important Safety Information

All surgical treatments have inherent and associated side effects. The most common side effects are mild and transient, and may include mild pain or difficulty when urinating, discomfort in the pelvis, blood in the urine, inability to empty the bladder or a frequent and/or urgent need to urinate, and bladder or urinary tract infection. Other risks include ejaculatory dysfunction and a low risk of injury to the urethra or rectum where the devices gain access to the body for treatment. For more information about potential side effects and risks associated with Aquablation therapy, speak with your urologist or surgeon. No claim is made that the AquaBeam Robotic System will cure any medical condition, or entirely eliminate the diseased entity. Repeated treatment or alternative therapies may sometimes be required.

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