Press Release Details

REDWOOD SHORES, Calif. – March 31, 2020 – PROCEPT^® BioRobotics, a surgical robotics company developing intelligent solutions to transform the field of urology, announced today that the European Association of Urology (EAU) has amended its 2020 guidelines to include a formal recommendation for Aquablation^® therapy as a treatment option for male lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH).

The revised EAU Non-Neurogenic Male LUTS Guidelines state that “Aquablation therapy may be offered to patients with moderate-to-severe LUTS and prostates between 30 and 80 mL as an alternative to transurethral resection of the prostate (TURP).” The new guidelines apply to men aged 40 years or older who seek professional help for LUTS in various non-neurogenic and non-malignant conditions such as LUTS/Benign Prostatic Obstruction (BPO), detrusor overactivity/overactive bladder (OAB) or nocturnal polyuria.

“Aquablation therapy has been providing relief to patients in Europe since 2017. The inclusion of our therapy in the EAU guidelines is a critical milestone for patients and physicians throughout Europe,” said Reza Zadno, PROCEPT BioRobotics president and chief executive officer. “Currently part of the American and Canadian guidelines, Aquablation therapy’s inclusion in the European guidelines further validates the clinical value of this procedure, allowing Aquablation therapy to effectively fill the existing treatment void of a durable, resective treatment that has a minimal risk of irreversible complications, including sexual side effects.”

The EAU Non-Neurogenic Male LUTS Guidelines Panel consists of an international group of experts with urological and clinical epidemiological backgrounds. The addition of Aquablation therapy was based on the review of new and relevant clinical studies representing high levels of evidence, including systematic reviews with meta-analysis, randomized controlled trials (RCTs), and prospective non-randomized comparative studies.

The EAU recommendation follows the addition of Aquablation therapy to the 2019 American Urological Association (AUA) surgical practice guidelines as a standard of care treatment for male LUTS due to enlarged prostate, the 2018 Canadian Urology Association (CUA) guideline on male lower urinary tract symptoms/benign prostatic hyperplasia (MLUTS/BPH), and the 2018 National Institute for Health and Care Excellence (NICE) Interventional Procedure Guidance for lower urinary tract symptoms.

Aquablation therapy is available in the U.S., Canada, the UK, Europe, the Middle East and Asia.

About the EAU

For almost 40 years the EAU has addressed the most pressing issues of urological care in Europe, through its scientific and educational initiatives, as well as its publications. Guidelines development is one of the core activities of the EAU as part of their educational efforts. The current corpus of available guidelines covers most of the urological field. The aim of the EAU Guidelines is to assist practicing clinicians in making informed decisions in a given circumstance; taking the highest quality scientific data, their patient’s personal circumstances, values and preferences into account. https://uroweb.org/guidelines/

About PROCEPT BioRobotics Corporation

PROCEPT BioRobotics is a surgical robotics company enabling better patient care by developing transformative solutions in urology. With an initial focus on BPH, the AquaBeam Robotic System delivering Aquablation therapy, is the first FDA-cleared, automated surgical robot for the treatment of lower urinary tract symptoms due to BPH. Aquablation therapy combines real-time, multi-dimensional imaging, automated robotics and heat-free waterjet ablation for targeted, controlled, and immediate removal of prostate tissue. Aquablation therapy offers predictable and reproducible outcomes, independent of prostate anatomy, prostate size or surgeon experience. For more information visit https://www.procept-biorobotics.com.

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.

Media Contact:
Diana Soltesz
Pazanga Health Communications
+1-818-618-5634
dsoltesz@pazangahealth.com