Six-Month Data Highlight Safety and Efficacy of PROCEPT BioRobotics’ Aquablation® Therapy as an Effective Minimally Invasive Surgical Treatment for BPH in Prostates up to 150 mL

Results From Francais WATER and WATER II Studies Will Be Presented at the European Association of Urology Annual Congress

PROCEPT BioRobotics, a Silicon Valley surgical robotics company, announced today that six-month data from two studies will be presented at the European Association of Urology (EAU) Annual Congress in Barcelona, Spain, March 15 – 19, 2019. The data will highlight the safety and efficacy of the FDA-approved PROCEPT BioRobotics’ Aquablation® therapy as a surgical treatment for benign prostatic hyperplasia (BPH) in prostates up to 150 milliliters (mL).

Six-month data from the Francais WATER Study (Waterjet Ablation Therapy for Endoscopic Resection of prostate tissue) evaluating the safety and efficacy of Aquablation therapy at three centers in France will be presented in an expert guided poster tour by Vincent Misrai, M.D., a urologic surgeon at Clinique Pasteur in Toulouse, France. Francais WATER follows the successful WATER Study, which demonstrated the superior safety and non-inferior efficacy of Aquablation versus transurethral resection of the prostate (TURP). The goal in the French trial was to determine if the WATER Study findings could be replicated in the local population. Francais WATER enrolled thirty men with moderate-to-severe lower urinary tract symptoms related to BPH. The poster, entitled PT186 – “Aquablation for Treating Benign Prostatic Obstruction in Small to Medium-Size Glands: Six Months-Outcomes of the First French Registry,” will take place Saturday, March 16 at 15:30-17:30 CET in Green Area, Room B.

Six-month data from the WATER II Study, evaluating the safety and efficacy of Aquablation therapy in large prostates 80 to 150 mL in size, will be presented by Mihir Desai, M.D., Professor of Clinical Urology and Vice Chair, New Technology & Innovation at the Keck School of Medicine of University of Southern California. WATER II enrolled 101 patients at 16 sites in the United States and Canada with the intent to validate and extend upon the results from the initial WATER Study, where IPSS improvement was superior with Aquablation in men with prostate volume greater than 50 ml as compared to TURP (p<0.02). Initial WATER II data were presented at the 2018 American Urological Association annual conference, meeting both the primary safety and efficacy endpoints and introducing Aquablation therapy as an effective minimally invasive surgical alternative for larger prostates. Recognized as one of the best posters by the EAU, Poster #1107 – “Aquablation for BPH in Large Prostates (80-150 mL): Six-Month Results from the WATER II Multicenter Trial,” will be presented Monday, March 18 at 14:00-15:30 CET in Green Area, Room 20.

“For prostates larger than 80 mL, the surgical options are limited and the risk of complications increase,” Dr. Desai said. “The combination of robotics and image guidance empowers the surgeon to consistently develop an optimal tissue removal plan and provide patients with safe and effective outcomes in a wide range of prostate sizes.”

“The data from the WATER II Study confirms that Aquablation is a viable therapy for this patient population, providing predictable and reproducible outcomes regardless of prostate volume and shape,” said PROCEPT BioRobotics President and Chief Executive Officer Nikolai Aljuri, Ph.D. “The results from both of these studies reinforce that, despite limited experience with Aquablation therapy, surgeons can offer their patients an optimal BPH treatment that provides a significant reduction in symptoms while minimizing the risk of sexual side effects.”

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