PROCEPT BioRobotics Corp. Announces United Healthcare Coverage of Aquablation Therapy for Men with Enlarged Prostates
03 4월 2023 - 9:00PM
PROCEPT® BioRobotics Corporation (Nasdaq: PRCT) (the
“Company”), a surgical robotics company focused on advancing
patient care by developing transformative solutions in urology,
today 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.
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.”
United Healthcare’s updated BPH coverage policy can be found
here:
-
https://www.uhcprovider.com/content/dam/provider/docs/public/policies/index/commercial/prostate-surgery-06012023.pdf
About Aquablation TherapyAquablation 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.
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.
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 projected financial
performance for full year 2022, 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
financial guidance, market opportunity and penetration, the
Company’s possible or assumed future results of operations,
including descriptions of the Company’s revenues, gross margin,
profitability, operating expenses, installed base growth,
commercial momentum, overall business or the overall macroeconomic
environment, which may impact customer spending or the Company’s
costs. 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
PROCEPT BioRobotics (NASDAQ:PRCT)
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