Aquablation therapy is a procedure being pioneered by PROCEPT that uses a heat-free water jet. Image credit: Shutterstock/slowmotiongli.

The US Food and Drug Administration (FDA) has awarded Procept Biorobotics an investigational device exemption (IDE), greenlighting a pivotal trial to test the company’s aquablation therapy to treat prostate cancer.

The trial, known as WATER IV PCa, is a global multicentre, prospective, randomised clinical study that will assess the safety and efficacy of PROCEPT’s technology compared to radical prostatectomy, a surgical procedure that removes the prostate gland and some surrounding tissue to treat prostate cancer.

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Shares in the NYSE-listed company rebounded at market open on 8 October following a dip the day prior.  

Analyst firms Piper Sandler, TD Cowen, and Truist Securities have all expressed confidence in the company’s growth trajectory and maintain buy ratings for its stock amid promise for the aquablation technology in oncological indications.

Aquablation therapy is a procedure being pioneered by PROCEPT that is designed to remove prostate tissue using a heat-free water jet. Aquablation works by delivering a high-pressure water jet controlled by a computer and robotic arm under the control of the surgeon. This heat-free method ablates enlarged prostate tissue with fewer side effects compared to other approaches.

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The technology is already approved by the FDA for resection and removal of prostate tissue in men suffering from lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH). A next-generation robot to deliver aquablation was cleared by the FDA in August 2024.  

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The now greenlit WATER IV PCa study will see PROCEPT attempt to make a splash in treating cancerous prostate growth. The study will enrol up to 280 patients with grade group 1 to 3 localised prostate cancer across 50 centres. Patients in both the aquablation group and the surgical group will be followed for 10 years, with a co-primary endpoint based on morbidity evaluated at the six-month follow-up. Longer-term follow-up will look at treatment-related harm and future cancer events.

Inderbir Gill, chairman at Catherine & Joseph Aresty Department of Urology, Keck School of Medicine of USC, said the study “could potentially change the way urologists treat localised prostate cancer for millions of men.”

PROCEPT’s CEO Reza Zadno said: “We believe Aquablation therapy has the ability to become a first line treatment for localized prostate cancer. Initiating a randomised trial against radical prostatectomy is the first big step in pursuing a prostate cancer specific indication– which no other energy-based treatment has today.”

Along with the pivotal trial clearance, the FDA also gave breakthrough device designation to PROCEPT. This provides prioritised review for the device’s submission in prostate cancer and the company can also interact quickly with FDA experts to discuss feedback during the premarket review phase.

PROCEPT won $85m in Series G financing in June 2021, helping commercialisation of its technology.