WATER Study One-Year Data and WATER II Primary Endpoint Data for PROCEPT BioRobotics’ Aquablation® Therapy to be Presented at AUA 2018
May. 15, 2018
REDWOOD SHORES, Calif.--(BUSINESS WIRE)--May 15, 2018--PROCEPT BioRobotics, a Silicon Valley surgical robotics company developing novel and disruptive technologies to treat prostate disease, announced today that the company’s Aquablation therapy for the treatment of benign prostatic hyperplasia (BPH) will be presented at several different educational sessions at the American Urological Association (AUA) Annual Meeting in San Francisco, May 18 – 21, 2018.
One-year follow-up data of the global Phase III WATER Study ( W aterjet A blation T herapy for E ndoscopic R esection of prostate tissue) comparing Aquablation therapy against transurethral resection of the prostate (TURP) will be presented by Peter Gilling, MD, co-principal investigator of the WATER Study and professor of surgery at the University of Auckland, Bay of Plenty Clinical School Tauranga, New Zealand. The session, titled “PD64-01 - The WATER Study Clinical Results – A Phase III blinded randomized trial of Aquablation vs. TURP with Blinded Outcome Assessment for Moderate-to-Severe LUTS in men with BPH,” will take place on Monday, May 21 at 1 pm PST in Moscone Convention Center West, room 2022. This one-year data will build on the WATER Study primary endpoint data featured at AUA 2017, which showed a superior safety profile for Aquablation therapy with very strong efficacy outcomes comparable to TURP.
The WATER II Study, evaluating the safety and efficacy of Aquablation therapy in large prostates 80 to 150 milliliters (mL) in size, has been accepted as a late-breaking abstract at the conference. The company’s second Phase III pivotal study, WATER II enrolled 101 patients at 16 sites in the U.S. and Canada with the intent to validate and extend upon the results from the initial WATER Study, which, in a subgroup of patients with prostates volumes of 50 to 80 mL, showed both a superior safety profile as well as superiority in International Prostate Symptom Score (IPSS) improvement. The presentation, titled “LBA-12 - Aquablation Procedural Outcomes for BPH in Large Prostates (80-150g): Results from the WATER II Study,” will be given by Mihir Desai, MD, Professor of Clinical Urology and Vice Chair, New Technology & Innovation at the Keck School of Medicine of USC, during the plenary session, “Next Frontier,” on Sunday, May 20 at 4 pm PST in Moscone Convention Center North, room Hall E.
In addition, Aquablation therapy will be presented at two pre-recorded live case video sessions as well as at multiple moderated poster sessions, including outcomes assessments of Aquablation therapy from the WATER Study in patients with larger prostates as well as the overall impact of heat-free waterjet resection on sexual function.
“The primary endpoint results of the WATER Study demonstrated that Aquablation therapy offers significant clinical advantages over TURP and we are excited to share the one-year results, supporting the durability of Aquablation therapy,” said Nikolai Aljuri, Ph.D., PROCEPT BioRobotics chief executive officer and founder. “We look forward to sharing the results from the WATER II study confirming that Aquablation can provide predictable and reproducible outcomes regardless of prostate volume or surgeon experience.”
Aquablation therapy, delivered by the AQUABEAM® System, is the first FDA granted surgical robot providing autonomous tissue removal for the treatment of BPH. Aquablation therapy combines the clarity of real-time, multi-dimensional imaging, autonomous robotics and heat-free waterjet ablation for targeted, controlled, and immediate removal of prostate tissue for the treatment of lower urinary tract symptoms (LUTS) caused by BPH.
For more information about Aquablation therapy with the AQUABEAM System, visit PROCEPT BioRobotics at AUA booth #5656 in Hall D of the Moscone Convention Center.
About PROCEPT BioRobotics
Based in Silicon Valley, PROCEPT BioRobotics is a privately-held surgical robotics company enabling better patient care by developing transformative solutions in urology. With an initial focus on BPH, PROCEPT BioRobotics offers the world’s first commercially available minimally invasive surgical robot providing autonomous tissue removal to safely and effectively treat BPH. Aquablation therapy offers predictable and reproducible outcomes, independent of prostate anatomy, prostate size or surgeon experience. The AQUABEAM System is commercially available in the United States, Canada, Australia, New Zealand and select European markets. http://www.PROCEPT-BioRobotics.com
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SOURCE: PROCEPT BioRobotics
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PUB: 05/15/2018 07:00 AM/DISC: 05/15/2018 07:01 AM