The National Institute for Health and Care Excellence Endorses Aquablation® Therapy with "Standard Arrangements" Recommendation
October 12 2023 - 8:00AM
PROCEPT BioRobotics® Corporation (NASDAQ: PRCT), a surgical
robotics global leader, is pleased to announce that the National
Institute for Health and Care Excellence (NICE) has bestowed its
strongest endorsement, the "standard arrangements" recommendation,
on Aquablation® therapy for the treatment of benign prostatic
hyperplasia (BPH). NICE plays a pivotal role in providing guidance
to enhance health and social care in the United Kingdom. For a
procedure to secure such a recommendation, it must demonstrate both
short-term and long-term safety and efficacy. NICE’s endorsement
underscores that the robotically assisted Aquablation therapy meets
these rigorous standards.
"Aquablation therapy has consistently shown itself to be a
reliable and safe robotic treatment for BPH over the years,” said
Dr Neil Barber, Clinical Lead of Urology, Frimley Health NHS
Foundation Trust and Director of the Frimley Benign Prostate
Clinical Research Centre. “Garnering the premier evidence-based
recommendation from NICE not only raises the standard of care for
urologists in the UK but also serves as a strong catalyst for its
broader adoption. We've witnessed countless men whose lives have
been dramatically improved by this treatment, evident from our
growing waiting list of those opting for Aquablation therapy over
other solutions."
"After an extensive multi-year evaluation, we're elated to share
that Aquablation therapy has received the top-tier recommendation
from NICE,” said Sham Shiblaq, Executive Vice President and Chief
Commercial Officer of PROCEPT BioRobotics. “Although NICE's purview
is the UK, its clinical endorsements have significant international
influence. This bolsters our conviction that Aquablation therapy is
on course to be the global standard of care for BPH."
About Aquablation TherapyAquablation therapy is
the first and only image-guided, robotically assisted, heat-free
water jet 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 surgeon uses the
robot to remove prostate tissue in a precise, targeted, and
controlled fashion using novel, heat-free waterjet technology.
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
therapy 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 therapy. 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. For more information, please
visit www.Aquablation.com and follow the company
on Facebook, Twitter and LinkedIn.
About PROCEPT BioRobotics CorporationPROCEPT
BioRobotics is a surgical robotics company focused on advancing
patient care by developing transformative solutions in urology.
PROCEPT BioRobotics develops, manufactures, and sells the AquaBeam
Robotic System, an advanced, image-guided, surgical robotic system
for use in minimally invasive urologic surgery with an initial
focus on treating benign prostatic hyperplasia, or BPH. BPH is the
most common prostate disease and impacts approximately 40 million
men in the United States. PROCEPT BioRobotics designed Aquablation
therapy to deliver effective, safe, and durable outcomes for males
suffering from lower urinary tract symptoms, or LUTS, due to BPH
that are independent of prostate size and shape or surgeon
experience. The Company has developed a significant and growing
body of clinical evidence, which includes nine clinical studies and
over 150 peer-reviewed publications, supporting the benefits and
clinical advantages of Aquablation therapy.
Forward Looking StatementsThis release contains
forward‐looking statements within the meaning of federal securities
laws, including with respect to the Company’s statements regarding
the potential utilities, values, benefits and advantages of
Aquablation therapy performed using PROCEPT BioRobotics’ products,
including AquaBeam® Robotic System, which involve risks and
uncertainties that could cause the actual results to differ
materially from the anticipated results and expectations expressed
in these forward-looking statements. You are cautioned not to place
undue reliance on these forward-looking statements. Forward-looking
statements are only predictions based on our current expectations,
estimates, and assumptions, valid only as of the date they are
made, and subject to risks and uncertainties, some of which we are
not currently aware. Forward-looking statements may include
statements regarding market opportunity and penetration, installed
base growth, commercial momentum, overall business or the overall
macroeconomic environment, which may impact customer spending or
the Company’s financial performance. Forward‐looking statements
should not be read as a guarantee of future performance or results
and may not necessarily be accurate indications of the times at, or
by, which such performance or results will be achieved. These
forward‐looking statements are based on the Company’s current
expectations and inherently involve significant risks and
uncertainties. Actual results and the timing of events could differ
materially from those anticipated in such forward‐looking
statements as a result of these risks and uncertainties. These
risks and uncertainties are described more fully in the section
titled “Risk Factors” in the Company’s filings with the Securities
and Exchange Commission (the “SEC”), including the Company’s annual
report on Form 10-K filed with the SEC on February 28, 2023.
PROCEPT BioRobotics does not undertake any obligation to update
forward‐looking statements and expressly disclaims any obligation
or undertaking to release publicly any updates or revisions to any
forward‐looking statements contained herein. These forward-looking
statements should not be relied upon as representing PROCEPT
BioRobotics’ views as of any date subsequent to the date of this
press release.
Important Safety Information
All surgical treatments have inherent and associated side
effects. For a list of potential side effects
visit https://aquablation.com/safety-information/.
Investor Contact:Matt Bacso, CFAVP, Investor
Relations and Business
Operationsm.bacso@procept-biorobotics.com
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