Today PROCEPT BioRobotics, a Silicon Valley robotics company developing intelligent surgical solutions to transform the field of urology, has announced early data from the global Phase III WATER II (Waterjet Ablation Therapy for Endoscopic Resection of prostate tissue) Study showing the achievement of primary safety and efficacy endpoints for Aquablation in the treatment of benign prostatic hyperplasia (BPH). Presented yesterday at the American Urological Association (AUA) Annual Meeting in San Francisco by Co-principal Investigator, Mihir Desai, M.D., Professor of Clinical Urology and Director, Center for Advanced Robotics at the Keck School of Medicine of USC, the data demonstrated that use of Aquablation in men with prostate volumes ranging from 80 to 150 milliliters (mL) resulted in a significant improvement in both symptom scores and urinary flow rates, with a safety profile that met its predefined endpoint with statistical significance.
Aquablation, delivered by PROCEPT BioRobotics’ AquaBeam® System, uses a robotically controlled waterjet to remove prostate tissue without the application of heat. The single-arm, prospective WATER II Study of Aquablation enrolled 101 male patients, ages 45 to 80 years and with urinary symptoms due to BPH, at 16 sites in the United States and Canada. WATER II is a follow-up to the successful WATER Study, which showed a superior safety profile for Aquablation with very strong efficacy outcomes comparable to transurethral resection of the prostate (TURP) for the treatment of BPH in prostates size 30 to 80 mL.
“On the heels of the WATER Study, the results of the WATER II Study confirmed Aquablation delivers predictable and reproducible results regardless of the size of the prostate,” said Dr. Desai. “These results suggest that Aquablation can be a minimally invasive, transurethral option for patients with larger prostates who would otherwise only be candidates for simple prostatectomy.”
In addition to the WATER II results, Dr. Desai reported on a pooled analysis of 364 men with prostates ranging from 20 to 150 mL who were treated with Aquablation as part of five different clinical trials across six countries. The purpose of the analysis was to assess multiple hemostasis techniques, with and without heat, used following Aquablation and the implications on bleeding outcomes. In the analysis of all 364 patients, Aquablation had a very low rate of major bleeding events, with a peri-operative transfusion rate of less than three percent in prostates up to 150mL in volume. In addition, the analysis showed that the use of heat-free hemostasis techniques demonstrated no difference in overall bleeding events as compared to cautery after Aquablation.
“The pooled analysis demonstrated that, despite the increased prostate size in WATER II, hemostasis can be successfully achieved following Aquablation without the use of heat,” said Dr. Desai. “Given the range of prostate sizes treated and studied, the procedural consistency and overall safety profile of Aquablation is unlike any other single surgical technique for BPH.”
BPH is a highly prevalent condition affecting approximately 50 percent of men age 60 or older and 90 percent of men age 85 or older. About half of men diagnosed with BPH experience moderate-to-severe lower urinary tract symptoms (LUTS). Today, patients must decide to treat their BPH with surgical treatments such as TURP, which offer sustained symptom relief but a high risk of complications, or minimally invasive techniques that have a low risk of complications but are less effective for symptom relief. Aquablation offers the potential for symptomatic improvement similar to TURP with a superior safety profile and minimal learning curve for the surgeon.
“PROCEPT BioRobotics is committed to sound clinical research and we are excited to have the results of our second pivotal study presented as part of the AUA late-breaking abstracts for the second year in a row,” said Nikolai Aljuri, Ph.D., co-founder and chief executive officer of PROCEPT BioRobotics. “The results again confirm Aquablation can offer men a significant improvement in quality of life with a low risk of sexual side effects and the potential of becoming the treatment of choice for men suffering from BPH, independent of the size and shape of their prostate.”