Five-Year Data from the WATER II Study Demonstrate Aquablation Therapy Delivers Significant Durable Improvement of Benign Prostatic Hyperplasia Symptoms while Preserving Sexual Function in Men with Large Prostates
28 4월 2023 - 9:00PM
PROCEPT® BioRobotics Corporation today announced that 5-year
results from the WATER II Study demonstrate that Aquablation
therapy, a minimally invasive, robotic, surgical treatment for
benign prostatic hyperplasia (BPH), safely and effectively provides
durable symptom relief and preserves sexual function out to five
years for men with large prostates (80 – 150mL). The study,
published in this month’s Journal of Urology, demonstrated that
patients continued to experience significant and long-term
improvement in their symptoms and quality of life.
The WATER II Study is the first FDA, prospective multicenter
study successfully completed for larger prostates. The 5-year
results maintained excellent clinical outcomes including a
significant reduction in IPSS (mean reduction of 16 points),
increase in peak urinary flow rate (Qmax, mean increase of 9.2
ml/sec) and improvement in quality of life (average reduction in
IPSS QoL of 3.3). Over five years the trial showed a surgical
retreatment rate of only 3.7% based on Kaplan-Meier analysis.
Aquablation therapy proved to provide significant symptom relief
for patients over five years while demonstrating no impact on
erectile function and minimal impact on ejaculatory function or
urinary continence. The WATER II evidence, combined with the prior
WATER study comparing Aquablation therapy to the “gold standard”
transurethral resection of the prostate (TURP), indicate that
Aquablation therapy is the only treatment modality that can
effectively treat all prostate glands with minimal impact on sexual
function or urinary continence.
“Aquablation therapy now has 5-year results from two pivotal
studies that demonstrate the reproducibility of Aquablation therapy
to deliver significant symptom relief while preserving sexual
function no matter the size of the patient’s prostate,”said Sham
Shiblaq, EVP and Chief Commercial Officer of PROCEPT BioRobotics.
“These results are further validated by the large and growing
number of hospitals and surgeons that have adopted Aquablation as
their new standard of care for the treatment of BPH.”
“The surgical management of BPH has undergone significant change
over the past 20 years but most surgical options are limited in one
way or another,” said Dr. Naeem Bhojani, manuscript lead author.
“With real time ultrasound guidance and robotic execution,
Aquablation therapy has the potential to treat prostates of nearly
any size and this 5-year data validates the durability and
reproducibility of the procedure.”
About Aquablation TherapyAquablation therapy is
the first and only image-guided, automated, heat-free robotic
therapy 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. PROCEPT BioRobotics 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.
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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