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PROCEPT BioRobotics Corp. Announces United Healthcare Coverage of Aquablation Therapy for Men with Enlarged Prostates

PROCEPT BioRobotics Corporation, a surgical robotics company focused on advancing patient care by developing transformative solutions in urology, announced that United Healthcare published an update to its Prostate Surgeries and Interventions Policy Bulletin that states Aquablation therapy is proven and medically necessary for the treatment of lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) when performed according to the FDA labeled indications, contraindications, warnings and precautions. The updated policy follows Aquablation’s FDA label and is effective June 1, 2023.

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United Healthcare is the largest health insurance company in the United States with over 45 million covered lives.

“We are very excited to announce the updated policy from United Healthcare and believe this will greatly improve accessibility of Aquablation therapy for men suffering from BPH.” said Reza Zadno, President and CEO. “With the addition of United Healthcare, we estimate approximately 95% of all men in the United States now have access to Aquablation therapy.”

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Aquablation therapy is the first and only image-guided, automated robotic therapy with heat-free resection, for the treatment of BPH. The system’s real-time ultrasound imaging provides the surgeon with a multi-dimensional view of the prostate enabling personalized treatment planning tailored to each patient’s unique anatomy. The surgeon can specify which areas of the prostate to remove while preserving the anatomy that controls erectile function, ejaculatory function and continence. Once the treatment plan is mapped, the automated robot removes prostate tissue in a precise, targeted, and controlled fashion using novel, heat-free waterjet technology.

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This novel technology is backed by numerous peer-reviewed publications demonstrating its safety, efficacy, and the durability of its outcomes. The cornerstone of the data is two prospective FDA trials with 5-year data; WATER and WATER II. The WATER study (the U.S. pivotal trial for FDA approval) randomized Aquablation against TURP, which has been the standard of care for resection of prostates smaller than 80ml, in a double-blinded study. The trial demonstrated superior safety and comparable efficacy to TURP in prostates 30ml to 80ml in size and superior safety and efficacy in prostates 50ml to 80ml in size. The WATER II study included men with a prostate size greater than 80ml undergoing Aquablation. The study met its pre-specified performance goal for safety and efficacy. The two FDA trials with 5-year follow-up have demonstrated consistent results across various prostate anatomy.

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