IDE enables a second randomized protocol evaluating Aquablation therapy versus active surveillance. Aquablation uses waterjet resection to precisely eradicate prostate tissue. It provides the potential for an effective cancer treatment while maintaining the patient’s quality of life.

In addition to the IDE, the company completed enrollment in its WATER IV study evaluating Aquablation versus radical prostatectomy.

The first randomized WATER IV study fully enrolled 280 patients. It’s the only FDA-randomized study comparing Aquablation to radical prostatectomy, the established surgical standard of care, the company said. The company expects to share primary endpoint results in 2027.