COMPANY
Zenflow, Inc.
FDA-cleared device company Clinical Phase 3
Timeline
- Raise Private equity round — Series D: $52M (total, as published), announced Oct 5, 2026. Source: company release on GlobeNewswire. source ↗
- Trial start Phase 4: Prospective Post Market Clinical Trial for the Zenflow Spring System - A Minimally Invasive Treatment for LUTS Associated With BPH. source ↗
- Trial start —: Prospective Post Market Clinical Registry for the Zenflow Spring System - A Minimally Invasive Treatment for LUTS Associated With BPH Spring System Registry source ↗
- FDA FDA PMA approval: Zenflow Spring® Implant and Delivery System — P250007, Dec 11, 2025. Applicant at approval: Zenflow, Inc. source ↗
- FDA FDA 510(k) clearance: Zenflow Spring Scope — K251140, Sep 23, 2025. Applicant at approval: Zenflow, Inc. source ↗
- Raise Private equity round — Series C: $24M (total, as published), announced Nov 19, 2024. Source: company release on GlobeNewswire. source ↗
- Trial start Not phased (device or behavioral study): Safety and Effectiveness Study of the Zenflow Spring System source ↗
- Trial start Not phased (device or behavioral study): The Zenflow Spring System Safety and Performance Study (ZEST CAN) source ↗
- Trial start Not phased (device or behavioral study): The Zenflow Spring System EU Safety and Performance Study source ↗
- Trial start Not phased (device or behavioral study): The Zenflow Spring System Safety, Performance and Effectiveness Study source ↗
- Trial start Not phased (device or behavioral study): The Zenflow Spring System Feasibility and Safety Study source ↗
Upcoming milestones
- 2028-07 (ESTIMATED) · · Prospective Post Market Clinical Registry for the Zenflow Spring System - A Minimally Invasive Treatment for LUTS Associated With BPH Spring System Registry · NCT07538622
- Sep 1, 2028 (ESTIMATED) · Phase 4 · Prospective Post Market Clinical Trial for the Zenflow Spring System - A Minimally Invasive Treatment for LUTS Associated With BPH. · NCT07797348
Funding
Clinical trials (lead sponsor) 7
| Record | Title | Phase | Status | Start | Primary completion |
|---|---|---|---|---|---|
| NCT07538622 | Prospective Post Market Clinical Registry for the Zenflow Spring System - A Minimally Invasive Treatment for LUTS Associated With BPH Spring System Registry | Not listed | Recruiting | Jul 29, 2026 | 2028-07 (estimated) |
| NCT07797348 | Prospective Post Market Clinical Trial for the Zenflow Spring System - A Minimally Invasive Treatment for LUTS Associated With BPH. | Phase 4 | Not yet recruiting | Sep 1, 2026 | Sep 1, 2028 (estimated) |
| NCT04987138 | Safety and Effectiveness Study of the Zenflow Spring System | Not phased (device or behavioral study) | Unknown status (ClinicalTrials.gov) | Sep 30, 2021 | Jun 30, 2024 (estimated) |
| NCT03577236 | The Zenflow Spring System EU Safety and Performance Study | Not phased (device or behavioral study) | Unknown status (ClinicalTrials.gov) | Jan 16, 2019 | 2022-12 (estimated) |
| NCT03595735 | The Zenflow Spring System Safety, Performance and Effectiveness Study | Not phased (device or behavioral study) | Unknown status (ClinicalTrials.gov) | Jun 21, 2018 | Dec 30, 2020 (actual) |
| NCT04309695 | The Zenflow Spring System Safety and Performance Study (ZEST CAN) | Not phased (device or behavioral study) | Unknown status (ClinicalTrials.gov) | Feb 9, 2021 | Dec 1, 2025 (estimated) |
| NCT02786290 | The Zenflow Spring System Feasibility and Safety Study | Not phased (device or behavioral study) | Unknown status (ClinicalTrials.gov) | 2016-04 | 2019-12 (estimated) |
FDA records (last 2 years)
NIH awards 4
- NIH award 5R44DK124094-02 FY2020: $557,376 awarded for that fiscal year; activity R44 (SBIR); PI DAMIANO, NICHOLAS; recipient as written: ZENFLOW, INC., SOUTH SAN FRANCISCO, CA. Improvement and validation of the Spri source ↗
- NIH award 1R44DK124094-01 FY2019: $713,814 awarded for that fiscal year; activity R44 (SBIR); PI DAMIANO, NICHOLAS; recipient as written: ZENFLOW, INC., SOUTH SAN FRANCISCO, CA. Improvement and validation of the Spri source ↗
- NIH award 5R44DK112587-02 FY2018: $636,601 awarded for that fiscal year; activity R44 (SBIR); PI DAMIANO, NICHOLAS; recipient as written: ZENFLOW, INC., SOUTH SAN FRANCISCO, CA. Spring System for Permanent Relief of source ↗
- NIH award 1R44DK112587-01A1 FY2017: $636,601 awarded for that fiscal year; activity R44 (SBIR); PI DAMIANO, NICHOLAS; recipient as written: ZENFLOW, INC., SOUTH SAN FRANCISCO, CA. Spring System for Permanent Relief o source ↗
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