PROCEPT BioRobotics® Receives U.S. FDA Investigational Device Exemption to Investigate Aquablation® Therapy for Prostate Cancer
12 Septiembre 2023 - 7:00AM
PROCEPT BioRobotics Corporation (NASDAQ: PRCT) (“PROCEPT
BioRobotics”), a global leader in surgical robotics, announced
today the Investigational Device Exemption (IDE) approval from the
U.S. Food and Drug Administration (FDA) to investigate the safety
and efficacy of Aquablation therapy for prostate cancer.
The IDE approval allows PROCEPT BioRobotics to initiate a
single-arm feasibility study in the United States. The data
generated from this IDE study will support future research and
regulatory applications in the United States. The study will enroll
patients with localized prostate cancer at three prestigious cancer
centers, Keck Medical Center of USC, Perlmutter Cancer Center at
NYU Langone Health, and Mount Sinai Tisch Cancer Center.
“Aquablation Therapy, recognized for its efficacy and safety in
resecting prostate tissue for BPH, offers a potential paradigm
shift in how urologists might address localized prostate cancer.
The waterjet resection technique has the distinct capability to
precisely eradicate prostate tissue, providing the potential of an
effective cancer treatment while maintaining the patient's quality
of life,” said Dr. Inderbir Gill, founding executive director
for USC Urology, part of Keck Medicine of USC. Gill is also
Distinguished Professor & Chairman, Catherine & Joseph
Aresty Department of Urology and Shirley & Donald Skinner Chair
of Urological Cancer Surgery at Keck School of Medicine of USC.
Reza Zadno, CEO of PROCEPT BioRobotics, remarked, "Receiving IDE
approval to explore Aquablation Therapy for men with localized
prostate cancer marks a pivotal moment for PROCEPT. While our
primary commitment is to establish ourselves as the standard of
care for the treatment of BPH, we acknowledge the distinctive
potential of our robotic system to address other urological
indications." Zadno added, "Our aim is to bolster the clinical
evidence through this study and collaborate with some of the
nation's foremost cancer physicians.”
PROCEPT BioRobotics will post an updated investor presentation
to its website, www.procept-biorobotics.com, on the “News &
Events” page under the “Investors” tab.
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
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. 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 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 the possible initiation of clinical trials,
potential regulatory approvals for additional indications, market
opportunity and penetration, 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 InformationAll surgical
treatments have inherent and associated side effects. For a list of
potential side effects
visit https://aquablation.com/safety-information/.
Investor Contact:Matt BacsoVP, Investor
Relations and Business
Operationsm.bacso@procept-biorobotics.com
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