COMPANY

Zenflow, Inc.

HQ: South San Francisco, CA source · zenflow.com ↗ · West Coast

FDA-cleared device company Clinical Phase 3

Also known as Zenflow · 15 sources

Location: South San Francisco, CA · source · Oct 15, 2026

Keywords: Benign Prostatic Hyperplasia urinary obstruction BPH (Benign Prostatic Hyperplasia) Obstructive Lower Urinary Tract Symptoms (LUTS) Enlarged Prostate Lower Urinary Tract Symptoms Zenflow Spring System

$76.0MRaised (2 yrs)7Trials (company is sponsor)2FDA records (2 yrs)4NIH grants

Timeline

Oct 5, 2026 Raise Private equity round — Series D: $52M (total, as published), announced Oct 5, 2026. Source: company release on GlobeNewswire. source ↗
Sep 1, 2026 Trial start Phase 4: Prospective Post Market Clinical Trial for the Zenflow Spring System - A Minimally Invasive Treatment for LUTS Associated With BPH. source ↗
Jul 29, 2026 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 ↗
Dec 11, 2025 FDA FDA PMA approval: Zenflow Spring® Implant and Delivery System — P250007, Dec 11, 2025. Applicant at approval: Zenflow, Inc. source ↗
Sep 23, 2025 FDA FDA 510(k) clearance: Zenflow Spring Scope — K251140, Sep 23, 2025. Applicant at approval: Zenflow, Inc. source ↗
Nov 19, 2024 Raise Private equity round — Series C: $24M (total, as published), announced Nov 19, 2024. Source: company release on GlobeNewswire. source ↗
Sep 30, 2021 Trial start Not phased (device or behavioral study): Safety and Effectiveness Study of the Zenflow Spring System source ↗
Feb 9, 2021 Trial start Not phased (device or behavioral study): The Zenflow Spring System Safety and Performance Study (ZEST CAN) source ↗
Jan 16, 2019 Trial start Not phased (device or behavioral study): The Zenflow Spring System EU Safety and Performance Study source ↗
Jun 21, 2018 Trial start Not phased (device or behavioral study): The Zenflow Spring System Safety, Performance and Effectiveness Study source ↗
2016-04 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

Estimated primary completion per ClinicalTrials.gov. Dates move.

Funding

Raised: $76.0M. Last 2 years.

Oct 5, 2026 Private equity round — Series D: $52M (total, as published), announced Oct 5, 2026. Source: company release on GlobeNewswire. source ↗
Nov 19, 2024 Private equity round — Series C: $24M (total, as published), announced Nov 19, 2024. Source: company release on GlobeNewswire. source ↗

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)

Dec 11, 2025 FDA PMA approval: Zenflow Spring® Implant and Delivery System — P250007, Dec 11, 2025. Applicant at approval: Zenflow, Inc. source ↗
Sep 23, 2025 FDA 510(k) clearance: Zenflow Spring Scope — K251140, Sep 23, 2025. Applicant at approval: Zenflow, Inc. source ↗

NIH awards 4

Annual award amounts. Total $2.5M.

Jul 8, 2020 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 ↗
Sep 15, 2019 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 ↗
Jul 27, 2018 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 ↗
Sep 15, 2017 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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