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REDWOOD SHORES, Calif.–(BUSINESS WIRE)–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 (Waterjet Ablation Therapy
for Endoscopic Resection 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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