Data Supported the FDA Approval of the Zenflow Spring® Implant and Delivery System for BPH
Additional presented data highlights patient satisfaction & long-term safety
SOUTH SAN FRANCISCO, Calif., May 18, 2026 (GLOBE NEWSWIRE) -- 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.
“With the recent approval, presenting our pivotal data on the main stage at AUA provided an important opportunity to communicate directly with urologists about how the Zenflow Spring provides a flexible, gentle solution that combines immediate efficacy with long term durability, and the ability to reverse the procedure, if ever needed,” said Shreya Mehta, CEO of Zenflow. “We’re excited to introduce the Zenflow Spring to urologists and their patients seeking a long-term solution that avoids previous barriers to treatment, such as fears of surgery, concerns about sexual performance, and need for post-operative catheterization.”
Poster Presentations Highlight Zenflow Attributes
The Zenflow Spring Implant and Delivery System was designed at Stanford Biodesign to optimize for the patient experience. It is the only system that uses a fully flexible scope to ensure patient comfort, and 3 sizes to ensure the best fit in a broad range of patient anatomies.
In a poster titled, “Patient Satisfaction after 12 Months using the Zenflow Spring System for treatment of Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia,” participants from the BREEZE pivotal trial were asked to complete a survey after 12 months, rating their satisfaction with the treatment’s improvement of their overall BPH symptoms, quality of life compared to baseline, satisfaction with sexual health, and willingness to recommend the Zenflow Spring Implant and Delivery System to others. Of the 100 participants who completed the survey, 66 percent reported that they would probably or definitely recommend the Zenflow Spring Implant and Delivery System to others. In addition, a majority agreed or strongly agreed (60%) that the treatment improved their overall BPH symptoms, with 59% stating their quality of life was improved over use of medical therapy. A majority of patients were satisfied with the treatment related to urinary function (71%) and with regard to sexual health, more than 80 percent (81%) were satisfied with the results.
A second poster titled, “Longitudinal Cystoscopic Evaluation of a Next Generation Prostatic Urethral Implant: Evaluation over 12 months,” demonstrated the durability of safety of the device, an important finding as other existing prostatic urethral implants have high rates of migration and encrustation that require removal. Evaluating patients (n=136) from the BREEZE pivotal trial at 12-months, researchers evaluated implant position, biofilm or encrustation, and edema to analyze any evidence of impact on efficacy (IPSS) or safety. The study found that there were no statistically significant differences demonstrating negative impact to efficacy in IPSS total score, change from baseline in IPSS total score, or responder rates with regards to implant position. Importantly there was no evidence that the implant was positioned at or migrated to interfere with the external urethral sphincter. No major encrustation was observed at 12 months. These results position Zenflow Spring as the only solution with long-term comprehensive data supporting reduced risks of encrustation and migration that can occur with other BPH solutions.
"The growing body of evidence behind the Zenflow Spring Implant and Delivery System—from the 12-month BREEZE pivotal trial data we presented at AUA to the 3-year follow-up from the ZEST pilot studies—makes a compelling case for its role in BPH care," said Dr. Elterman. "This is a first-line interventional therapy that delivers meaningful symptom relief with rapid recovery, minimal side effects, and the flexibility to preserve future treatment options for patients."
About Benign Prostatic Hyperplasia
Found in the male reproductive system, the prostate is a small gland that helps make semen and surrounds the tube that carries urine out of the body called the urethra. As men get older, the prostate can grow larger, which is called benign prostatic hyperplasia (BPH) or enlarged prostate. This growth can press on the urethra, making it harder to urinate and leading to symptoms that disrupt quality of life, including difficulty starting or fully emptying the bladder, a weak or interrupted stream, increased frequency and urgency, nighttime urination, and discomfort. An estimated 32 million men over the age of 60 in the United States and 79 million men worldwide live with BPH.1 More than 50% of men are impacted by BPH symptoms by age 50, 70% of men by age 70, and 90% of men by age 80.2
About Zenflow
Zenflow, Inc. is a medical device company dedicated to transforming urologic care with superior design and patient-focused innovation. The innovative Zenflow Spring® Implant and Delivery System (Zenflow Spring® Scope, Implant, and Delivery system) was designed to optimize the patient experience for men living with benign prostatic hyperplasia (BPH) symptoms. For more information, visit www.zenflow.com, and follow Zenflow on LinkedIn and X for the latest updates.
1. Ye, Z., Wang, J., Xiao, Y. et al. Global burden of benign prostatic hyperplasia in males aged 60–90 years from 1990 to 2019: results from the global burden of disease study 2019. BMC Urol 24, 193 (2024). https://doi.org/10.1186/s12894-024-01582-w https://link.springer.com/article/10.1186/s12894-024-01582-w#citeas
2. Roehrborn CG. Benign prostatic hyperplasia: an overview. Rev Urol. 2005;7 Suppl 9(Suppl 9):S3-S14. PMID: 16985902; PMCID: PMC1477638. https://pmc.ncbi.nlm.nih.gov/articles/PMC1477638/#B1
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