SOUTH SAN FRANCISCO, Calif., May 18, 2026 — Zenflow, Inc. recently presented data from its BREEZE™ pivotal clinical trial demonstrating the efficacy and safety of the Zenflow Spring® Implant and Delivery System, which was FDA approved in December 2025 for the treatment of symptoms associated with benign prostatic hyperplasia (BPH), also known as enlarged prostate. These data were presented during a main stage plenary session at the American Urological Association (AUA) annual meeting, held May 15-18, 2026, in Washington, D.C.
A prospective, multi-center, multinational, randomized, single-blinded controlled clinical trial, the BREEZE study met all primary safety and effectiveness endpoints in the intended use population. As presented by lead investigator Dean Elterman, M.D., associate professor at the University of Toronto and attending urologist at the University Health Network, in the intended use population, the responder rate was 60 percent (compared to 33 percent for sham) at one year, with a mean International Prostate Symptom Score (IPSS) improvement of 37 percent exceeding the pre-specified clinical success threshold of 30 percent. The study also reported best-in-class safety outcomes demonstrating that 99% of men did not need a post-procedure catheter, a 0 percent device-related Serious Adverse Event (SAE) rate, and an overall related AE rate of 13 percent.