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AUA Amends Clinical Practice Guidelines to Include PROCEPT BioRobotics’ Aquablation® Therapy as a Standard of Care Option for the Treatment of Enlarged Prostate

May 3, 2019

REDWOOD SHORES, Calif.--(BUSINESS WIRE)--May 3, 2019--PROCEPT® BioRobotics, a Silicon Valley surgical robotics company, announced today that the American Urological Association (AUA) has amended its surgical practice guidelines to include Aquablation® therapy as a standard of care treatment for male lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH), or enlarged prostate.

The AQUABEAM® Robotic System, delivering Aquablation therapy, is the first FDA granted surgical robot providing autonomous tissue removal for the treatment of BPH. The robot provides precise, robotically-controlled resection of prostate tissue with a heat-free waterjet, based on the surgeon’s personalized treatment plan for each individual patient.

The amended AUA guidelines state that Aquablation therapy may be offered to patients with LUTS attributed to BPH. This recommendation for Aquablation therapy follows the 2018 addition of Aquablation therapy to the Canadian Urological Association guideline on male urinary tract symptoms. The amendment from the AUA comes just a year after a revision in 2018, with a previous revision not since 2010, and represents a commitment by the AUA to include the most recent clinical evidence supporting new treatment options for men with BPH. The guidelines were developed under peer review prior to the AUA Board of Directors’ approval.

The subject of significant clinical research, Aquablation therapy was compared to the surgical gold standard Transurethral Resection of the Prostate (TURP) in the global, randomized and double-blinded WATER ( W aterjet  A blation  T herapy for  E ndoscopic  R esection of prostate tissue) study. In 2017, initial published data showed Aquablation therapy demonstrated very strong efficacy outcomes comparable to TURP with a superior safety profile, including a reduction in sexual side effects by a ratio of four to one. One-year follow-up data confirmed a sustained reduced rate of sexual side effects, durability in symptom reduction, improved flow rates, and a very low rate of retreatment. In addition, in prostates larger than 50ml the Centers for Medicare and Medicaid Services (CMS) found Aquablation therapy to represent a “substantial clinical improvement” to both TURP and simple prostatectomy. Longer-term two-year follow-up data from the WATER Study together with the one-year follow update from very large prostates greater than 80ml is being presented at the 2019 AUA Annual Meeting in Chicago, May 3 - 6.

“We commend the AUA for amending the guidelines just one year after the prior revision so that this revolutionary technology is available to patients without delay,” said Nikolai Aljuri, Ph.D., PROCEPT BioRobotics president and chief executive officer. “The recommendation from the AUA helps provide immediate access to Aquablation therapy to men looking for gold standard symptom improvement without the high risk of sexual side effects.”

About PROCEPT BioRobotics

Based in Silicon Valley, PROCEPT BioRobotics is a privately held surgical robotics company enabling better patient care by developing transformative solutions in urology. Aquablation therapy, delivered by the AQUABEAM Robotic System, is the first FDA granted surgical robot providing autonomous tissue removal for the treatment of BPH. 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 for the treatment of LUTS caused by BPH. Aquablation therapy offers predictable and reproducible outcomes, independent of prostate anatomy, prostate size or surgeon experience. http://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.

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CONTACT: Diana Soltesz

Nobles Global Communications

+1-818-618-5634

diana@noblesgc.com

KEYWORD: UNITED STATES NORTH AMERICA CALIFORNIA ILLINOIS

INDUSTRY KEYWORD: SURGERY HEALTH CLINICAL TRIALS HOSPITALS MEDICAL DEVICES RESEARCH FDA SCIENCE GENERAL HEALTH

SOURCE: PROCEPT BioRobotics

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PUB: 05/03/2019 07:00 AM/DISC: 05/03/2019 07:00 AM

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