PROCEPT Announces 5-Year WATER Study Data Comparing Aquablation to TURP
15 2월 2022 - 6:03AM
PROCEPT BioRobotics Corporation (Nasdaq: PRCT), a surgical robotics
company focused on advancing patient care by developing
transformative solutions in urology, today announced positive
five-year results from its 181 patient randomized WATER study
comparing Aquablation therapy to TURP, the historical standard of
care for treating BPH.
WATER is the only prospective, randomized, double-blind,
multicenter FDA pivotal study comparing the safety and efficacy of
Aquablation to TURP. The study proved superior safety due to low
irreversible complications and also superior symptom relief for
prostates in the range of 50 milliliters or greater.
At five years, IPSS scores improved by 15.1 points in the
Aquablation group and 13.2 points in TURP (p=.2764). However, for
men with larger prostates greater than 50 milliliters, IPSS
reduction was 3.5 points greater across all follow-up visits in the
Aquablation group compared to the TURP group (p=.0123). Improvement
in peak urinary flow rate was 125% and 89% compared to baseline for
Aquablation and TURP, respectively. Retreatment rates, defined as
needing BPH medication or surgical intervention, was approximately
1% per year for Aquablation, which was a 51% reduction compared to
TURP.
“The urological community has been waiting to
see if the early, pronounced benefits from Aquablation would remain
over time. With the 5-year data from a randomized study now
available, the Aquablation results are quite durable and look to
have a very low rate of men needing an additional treatment. Given
the broader range of prostate size and anatomy Aquablation can
treat, this technology has the potential to change the paradigm of
how BPH is treated,” said Dr. Alexis E. Te1, Professor of Urology
at the Weill Medical College at Cornell University.
“Based on our 5-year WATER data and real-world
experience, we believe Aquablation therapy is poised to become the
treatment of choice for BPH as it addresses the compromise between
safety and efficacy. This study reinforces the durability of
Aquablation therapy, and we are thrilled that men everywhere
suffering from BPH now have a surgical treatment option with proven
clinical outcomes, independent of the size and shape of the
prostate, and a reduced risk of sexual side effects,” said Reza
Zadno, President and Chief Executive Officer of PROCEPT
BioRobotics.
To view the publication, visit:
https://www.canjurol.com/html/free-articles/Cdn_JU29_I1_05_FREE_DrGilling.pdf
1Dr. Alexis E. Te was a study site principal investigator for
the WATER study and consultant to PROCEPT BioRobotics.
About PROCEPT BioRobotics Corporation
PROCEPT BioRobotics is a surgical robotics
company focused on advancing patient care by developing
transformative solutions in urology. PROCEPT 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
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. PROCEPT has developed a significant and growing
body of clinical evidence, which includes nine clinical studies and
over 100 peer-reviewed publications, supporting the benefits and
clinical advantages of Aquablation therapy.
Forward Looking Statements
This release contains forward‐looking statements
within the meaning of federal securities laws, including statements
regarding the potential utilities, values, benefits and advantages
of Aquablation® therapy performed using PROCEPT’s 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 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 PROCEPT’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
PROCEPT’s filings with the Securities and Exchange Commission (the
“SEC”), including PROCEPT’s quarterly report on Form 10-Q for the
quarter ended September 30, 2021. PROCEPT 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’s 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. 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.
Investor Contact:
Gilmartin GroupMatt Bacso, CFAMatt.bacso@gilmartinir.com
PROCEPT BioRobotics (NASDAQ:PRCT)
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