# Zenflow, Inc.

> Zenflow is a South San Francisco medical device company that built the Spring, a small nitinol coil implanted through a flexible cystoscope to prop open the urethra and relieve the symptoms of an enlarged prostate (benign prostatic hyperplasia). Spun out of Stanford's Biodesign program in 2014, the company won FDA approval in December 2025 for a first-line interventional therapy that requires no catheter afterward, preserves sexual function, and can be reversed. It has raised roughly $85 million across multiple rounds and ran the multinational BREEZE pivotal trial to get there.

- **Founded:** 2014
- **Headquarters:** South San Francisco, California, United States
- **Founders:** Nick Damiano (Co-founder), Shreya Mehta (Co-founder & CEO (former CTO))
- **Team size:** ~42 employees
- **Products:** Zenflow Spring Implant and Delivery System, Zenflow Spring Scope
- **Notable:** FDA approval of the Spring Implant and Delivery System as a first-line interventional therapy for BPH (December 2025)., First BPH therapy delivered via a flexible cystoscope., FDA 510(k) clearance for a first-of-its-kind single-use flexible cystoscope.

## Products & services

- **Zenflow Spring Implant and Delivery System** — A small spring-like implant made from superelastic shape-memory nitinol that props open the urethra to relieve BPH symptoms. Delivered in an outpatient setting, it requires no post-procedure catheterization, preserves natural anatomy and sexual function, and is reversible. FDA approved as a first-line interventional therapy.
- **Zenflow Spring Scope** — A first-of-its-kind single-use flexible cystoscope used to deliver the Spring implant, FDA 510(k) cleared. It is the first BPH therapy delivered via a flexible cystoscope.

## Achievements

- FDA approval of the Spring Implant and Delivery System as a first-line interventional therapy for BPH (December 2025).
- First BPH therapy delivered via a flexible cystoscope.
- FDA 510(k) clearance for a first-of-its-kind single-use flexible cystoscope.
- BREEZE pivotal trial met all primary safety and effectiveness endpoints (60% responder rate vs 33% sham; 0% device-related serious adverse events).
- Three-year durability data showing a sustained 74% responder rate.
- Raised roughly $85M to fund development, trials, and commercialization.

## Latest updates

- **2025-12** — FDA approves the Zenflow Spring Implant and Delivery System as a first-line interventional therapy for BPH.
- **2026-05** — Zenflow presents the BREEZE pivotal clinical trial results at the American Urological Association Annual Meeting.
- **2024-11** — Zenflow closes a $24M Series C to fund FDA filing and commercial preparation.

## Links

- Website: https://zenflow.com
- LinkedIn: https://www.linkedin.com/company/zenflowinc
- Twitter/X: https://twitter.com/zenflowinc
- Facebook: https://facebook.com/zenflowinc

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Last updated: 2026-07-09