The Company also recently received Breakthrough Device Designation to investigate the use of Aquablation therapy for prostate cancer. Breakthrough Device Designation is awarded in exceptional cases, expediting the review of novel therapies that can improve the lives of people with life-threatening or irreversibly debilitating diseases or conditions.

The trial, known as WATER IV PCa, is a global multicenter, prospective, randomized clinical study assessing the safety and efficacy of Aquablation therapy compared to radical prostatectomy in men with Grade Group 1 to 3 localized prostate cancer.

The study will enroll up to 280 patients at up to 50 centers and follow them for 10 years. There is a co-primary endpoint based on morbidity evaluated at the six-month follow-up. Longer-term follow-up focuses on both the reduction in treatment related harm and oncologic events.