WATER Study to evaluate the effectiveness and safety of Aquablation in the targeted and heat-free resection of prostate tissue
REDWOOD SHORES, California, December 3, 2015 – PROCEPT BioRobotics, a medical device company developing a novel minimally invasive water ablation therapy to surgically treat prostate disease, announced that Peter Gilling, MD, of Urology Bay of Plenty, Tauranga, New Zealand, has treated the first patients in a global Phase III clinical study evaluating the safety and effectiveness of the AQUABEAM® System as compared to the current standard of care, transurethral resection of the prostate, or TURP. The AQUABEAM System combines image guidance and robotics to deliver Aquablation, a waterjet ablation therapy that enables targeted, controlled, and heat-free removal of the tissue for the treatment of lower urinary tract symptoms caused by benign prostatic hyperplasia (BPH), a common prostate problem affecting more than 50% of men over 50 years in age.
The WATER study (Waterjet Ablation Therapy for Endoscopic Resection of prostate tissue) is a prospective randomized U.S. investigational device exemption (IDE) clinical trial for male patients between the ages of 45 and 80 years old who have urinary symptoms due to BPH. The WATER study will enroll over 200 patients in up to 20 global sites including 12 sites in the United States. Peter Gilling, MD, Associate Professor of Surgery at Tauranga Hospital, Tauranga, Bay of Plenty, New Zealand and Claus Roehrborn, MD, Chair of the Department of Urology at UT Southwestern are the co- Principal Investigators for the WATER study.
“Despite the advances with laser technology, TURP is still the most common procedure worldwide for the treatment of lower urinary tract symptoms, and while it has demonstrated durable results, it does come with certain risks affecting sexual function, ejaculation, and incontinence problems,” commented Dr. Gilling. “The AQUABEAM System utilizes a heat-free approach and along with the combination of image guidance and robotics has the potential to standardize BPH surgery, reduce the level of complexity required to deliver safe and effective therapy and ultimately improve the quality of life for men suffering from BPH. This trial has been designed to evaluate these measures.”
“The early clinical experience with Aquablation has demonstrated much promise and has evolved into a treatment scalable to hospitals worldwide,” said Nikolai Aljuri, Ph.D., co- founder and chief executive officer of PROCEPT BioRobotics. “The initiation of the WATER study is an important step to achieve our goal of providing men suffering from BPH a minimally invasive solution that offers both a sustainable and significant improvement to quality of life and a reduced risk of sexual side effects.”
About PROCEPT BioRobotics
PROCEPT BioRobotics is a privately held medical device company that develops a novel minimally invasive technology to surgically treat prostate disease. The first product developed is the AQUABEAM System, an intelligent image-guided robotic system delivering Aquablation, a personalized waterjet tissue resection modality. Under real-time image- based ultrasonic guidance, the AQUABEAM System enables surgical planning and mapping, and allows for a controlled resection of the prostate with a high-velocity saline stream. The combination of surgical mapping and controlled resection of the prostate is designed to offer predictable and reproducible outcomes which will enable quicker adoption and scaling of the technology. The company is privately held and headquartered in Redwood Shores, California. The AQUABEAM System is available for investigational use only in the United States and not currently available for sale in the United States