SAN JOSE, Calif., Oct. 12, 2023 (GLOBE NEWSWIRE) -- 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 Therapy
Aquablation 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 Corporation
PROCEPT 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 Statements
This 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.
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, CFA
VP, Investor Relations and Business Operations
m.bacso@procept-biorobotics.com
