PROCEPT BioRobotics Announces Three-Year Follow-Up Data Confirming Sustained Efficacy, Superior Safety of Aquablation® Therapy for Benign Prostatic Hyperplasia

REDWOOD CITY, Calif.--(BUSINESS WIRE)--PROCEPT BioRobotics Corporation, a surgical robotics company developing intelligent solutions to transform the field of urology, has announced that three-year follow-up data from the blinded, randomized WATER clinical study (Waterjet Ablation Therapy for Endoscopic Resection of prostate tissue) has confirmed the efficacy, safety, and durability of Aquablation therapy for the treatment of benign prostatic hyperplasia (BPH). The data, published in the Canadian Journal of Urology, compared Aquablation therapy, delivered by the AquaBeam® Robotic System, with transurethral resection of the prostate (TURP). This publication not only builds upon the increasing evidence for Aquablation therapy, but also confirms that Aquablation therapy provides both durable symptom relief and a sustained safety advantage compared to TURP.

“The publication of these three-year study results is a very important milestone for PROCEPT BioRobotics, as it provides compelling evidence of the long-term durability and safety of Aquablation therapy,” said Reza Zadno, president and CEO of PROCEPT BioRobotics. “We are thrilled to see the results and agree with the study co-authors, who concluded that autonomous robotic technology may ultimately offer standardization that improves overall outcomes for all urologists and their patients.”

The AquaBeam Robotic System is the first FDA-granted surgical robot for the autonomous removal of prostate tissue in males suffering from benign prostatic hyperplasia. In the study, 181 patients with prostates sized 30 to 80 cc were randomized to either Aquablation therapy or TURP. At three years, investigators found that improvements in IPSS scores, Qmax, PVR, and PSA were statistically similar across groups, but noted superior symptom improvement in the Aquablation therapy arm for patients with prostates larger than 50cc. Moreover, changes in MSHQ-EjD and MSHQ bother scores were significantly lower in the Aquablation therapy group. Additionally, no patients required surgical retreatments for BPH beyond 20 months.

“The high quality results of this three-year study build on a large foundation of clinical data supporting the safety and efficacy of Aquablation therapy for the treatment of BPH,” said Study Co-author Peter Gilling, M.D, Professor of Surgery at the University of Auckland, Bay of Plenty Clinical School Tauranga. “Unlike any other BPH treatment currently available, Aquablation therapy integrates image guidance and robotic execution, and I believe that Aquablation has the potential to become a new standard of care for urologists and their patients.”

About PROCEPT BioRobotics Corporation

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, the AquaBeam Robotic System delivering Aquablation therapy is the first FDA granted surgical robot providing autonomous tissue removal for the treatment of BPH due to lower urinary tract symptoms. 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. Aquablation therapy offers predictable and reproducible outcomes, independent of prostate anatomy, prostate size or surgeon experience. For more information visit https://www.procept-biorobotics.com.

Important Safety Information

All surgical treatments have inherent and associated side effects. The most common side effects are mild and transient, and may include mild pain or difficulty when urinating, discomfort in the pelvis, blood in the urine, inability to empty the bladder or a frequent and/or urgent need to urinate, and bladder or urinary tract infection. Other risks include ejaculatory dysfunction and a low risk of injury to the urethra or rectum where the devices gain access to the body for treatment. For more information about potential side effects and risks associated with Aquablation therapy, speak with your urologist or surgeon. No claim is made that the AquaBeam Robotic System will cure any medical condition, or entirely eliminate the diseased entity. Repeated treatment or alternative therapies may sometimes be required.