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.”
“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,” said Nikolai Aljuri, Ph.D., co-founder and chief executive officer of PROCEPT BioRobotics.
