Data Presented at the AUA Meeting Reflect Longest-Term Data among FIT Interventions
Reno, Nevada (UroToday.com) -- Zenflow, Inc. announced the results of long-term data demonstrating that the investigational Zenflow Spring® System offers significant and durable benefits three years after placement. The Zenflow Spring is leading the way in establishing a new category of treatment, First-Line Interventional Therapy or “FIT”, for patients suffering from benign prostatic hyperplasia (BPH) or enlarged prostate. The goal of FIT is to provide clinicians with minimally invasive therapies that offer distinct safety advantages such as ability to reverse treatment if desired, more like a medication. The research was presented at the 2025 Annual Meeting of the American Urological Association in Las Vegas. Subjects treated with the Zenflow Spring showed statistically significant and sustained reduction in their International Prostate Symptom Score (IPSS) from baseline at all assessment time points. Highlights from the ZEST pilot studies include:
- At 36 months, IPSS was 46% improved relative to baseline (11.8 vs. 22.0).
- The negative impact of BPH symptoms on quality of life was half that at baseline (IPSS-QOL 2.23 vs. 4.49), and Qmax increased to 13.9 mL/s from 10.6 mL/s at baseline.
- The responder rate, calculated as the proportion of subjects with ≥ 30% improvement in IPSS, was 74% at 36 months, similar to 75% at 12 months and 70% at 24 months.
- No deterioration in erectile or ejaculatory function was seen over time through 36 months.
“It’s exciting to see the front-runner in the FIT category continue to deliver consistent, long-term results for men living with BPH. Zenflow is the first to demonstrate this level of durability, and the only device offering a range of lengths and diameters to provide a truly tailored therapy. This new data reinforces earlier findings on durability and chronic safety, particularly the absence of implant encrustation or migration – making Zenflow a standout innovation in the field, and one to watch,” he said.“We’re encouraged to see the three-year data build upon the strong efficacy and durability results we saw at two years, further underscoring the Zenflow Spring as a promising, much-needed alternative for BPH patients and urologists seeking FIT options. We look forward to sharing developments with the urology community as we move toward FDA approval and commercial launch,” said Shreya Mehta, CEO.
The ZEST pilot studies included 72 subjects who received the Zenflow Spring device. Symptom improvement was measured using IPSS and IPSS-QOL; functional improvement was measured by peak urinary flow rate (Qmax). Overall effectiveness measures were calculated using a mixed model repeated measures (MMRM) analysis, which incorporates within-patient correlations and missing data, and equally weighs results from each study. Sexual health was monitored using the Sexual Health Inventory for Men (SHIM) and the Male Sexual Health Questionnaire –Ejaculatory Domain (MSHQ-EjD).
The safety and effectiveness of the Zenflow Spring System is currently being evaluated through BREEZE, a large, multi-center, prospective randomized study in the United States and Canada.
Source: Zenflow, Inc. (2025). Three-Year Data of Zenflow’s Spring System Demonstrate Durability of Clinical Benefits For Patients Suffering from BPH [Press release]. https://www.zenflow.com/news.