Procept BioRobotics, a device company focused on treating benign prostatic hyperplasia (BPH), said early results of a phase 3 trial show that its water-based ablation technology reached primary and efficacy endpoints.
Results from the global Water II study were presented over the weekend at the American Urological Association Annual Meeting in San Francisco. The study showed using aquablation delivered by the company’s AquaBeam system in men with prostate volumes ranging from 80 to 150 milliliters significantly improved both symptom scores and urinary flow rates.
The California-based company’s AquaBeam uses image guidance and robotics to deliver minimally invasive water-jet ablation therapy using saline, which it calls aquablation, for targeted, heat-free removal of tissue to treat lower urinary tract symptoms without side effects typically associated with heat-based ablation. Those side effects can include bleeding, dysuria, incontinence and sexual dysfunction.
“On the heels of the Water study, the results of the Water II study confirmed aquablation delivers predictable and reproducible results regardless of the size of the prostate,” Mihir Desai, M.D., co-principal investigator and a professor at the Keck School of Medicine at the University of Southern California, said in a statement. “These results suggest that aquablation can be a minimally invasive, transurethral option for patients with larger prostates who would otherwise only be candidates for simple prostatectomy.”
Additionally, the company reported that a pooled analysis of 364 men with prostates ranging from 20 to 150 milliliters who were treated with aquablation had very low rates of major bleeding events, with a peri-operative transfusion rate of less than 3% in prostates up to 150 milliliters in volume.