What Zenflow does

Zenflow is a venture-backed medical device company headquartered in South San Francisco that develops minimally invasive implants for the treatment of benign prostatic hyperplasia (BPH). The company was founded out of the Stanford Byers Center for Biodesign and built a clinical evidence base across three trials covering more than 300 patients (Phase I Feasibility, Phase II ZEST Pilot, and Phase III BREEZE Pivotal IDE) before receiving FDA approval in December 2025 for its Spring Implant and Delivery System as a first-line interventional therapy for BPH.

The core product is a self-expanding nitinol implant delivered through a fully flexible scope using a balloon-anchor delivery system with HD visualization during release. Three implant size options enable anatomical customization, and the design is fully reversible without piercing, cutting, heating, or tissue removal. Clinical evidence highlights include a 0% device/procedure-related serious adverse event rate, 0% surgical reintervention through 12 months, 99% of men not requiring a post-procedure catheter, a 62% responder rate at one year with a mean 9-point IPSS improvement, and 100% preservation of sexual function. A companion single-use cystoscope received FDA 510(k) clearance in September 2025.

Zenflow's revenue model is hardware sales of the Spring Implant and Delivery System (and the companion cystoscope) directly to urology practices, hospitals, and ambulatory surgery centers, executed through an enterprise field-sales motion targeting urologists and supported by conference engagement (AUA, EAU) and key opinion leader advocacy. The company has raised approximately $48 million across disclosed funding rounds, including a $24 million Series B led by Invus Opportunities in 2021 and a $24 million Series C in November 2024 led by Cook Medical with participation from F-Prime, Invus Opportunities, MedTech Venture Partners, Golden Seeds, and Propel(X). Revenue is not yet recognized; the company is in pre-commercial preparation following December 2025 FDA approval.

Name

Zenflow

Legal name

Zenflow, Inc.

Website

https://zenflow.com

Company type

Private

Founded year

2014

Operating status

Operating

Headcount range

11–50 employees

Short description

Zenflow is a South San Francisco medical device company that has developed and received FDA approval for the Spring Implant and Delivery System, a reversible, minimally invasive nitinol implant for treating benign prostatic hyperplasia, sold to urologists, hospitals, and ambulatory surgery centers.

Ownership category

akta.pro rank

Product category

Urology Medical Devices

NAICS

Surgical Appliance and Supplies Manufacturing (339113), Electromedical and Electrotherapeutic Apparatus Manufacturing (334510)

SIC

Surgical & Medical Instruments & Apparatus (3841), Orthopedic, Prosthetic & Surgical Appliances & Supplies (3842)

akta.pro primary industry

Intraoperative Imaging & Guidance (C-arms, O-arm, IOUS, fluorescence) (HLAHADAH)

Keywords

• Urology medical devices
• BPH treatment devices
• Interventional urology
• Nitinol implants
• Minimally invasive implants

Headquarters

HQ city

South San Francisco

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Marketing or Sales, Supply Chain, Others

Revenue model

1. Spring Implant and Delivery System Sales: Zenflow generates revenue through the sale of its FDA-approved Spring Implant and Delivery System to urology practices, hospitals, and other healthcare providers for the treatment of BPH. The device is a one-time implantable product used in a clinical procedure.

Go-to-market motion1 record

Distribution channels2 records

Marketing channels6 records

Core offering

Zenflow develops, manufactures, and commercializes the Spring Implant and Delivery System, an FDA-approved (December 2025) minimally invasive medical device for treating benign prostatic hyperplasia (BPH) in men. The self-expanding nitinol implant is delivered through a fully flexible scope with a balloon-anchor delivery system and is sold directly to urology practices, hospitals, and ambulatory surgery centers for use by urologists as a first-line interventional BPH therapy.

Product overview

Zenflow offers a focused portfolio of medical devices for treating benign prostatic hyperplasia (BPH). The core offering is the Zenflow Spring Implant and Delivery System, an FDA-approved minimally invasive treatment. This system is supported by the companion Single-Use Cystoscope (FDA 510(k) cleared) for procedure delivery. Clinical validation comes from the ZEST Pilot Study (Phase II, 80+ patients) and the BREEZE Pivotal Study (Phase III, 200+ patients). The Spring System provides a reversible, tissue-preserving alternative to traditional BPH procedures, designed at Stanford Biodesign and now FDA-approved as a first-line interventional therapy.

Differentiator

Problem solved

Functional benefit

Brands

• Spring System: Minimally invasive treatment for benign prostatic hyperplasia (BPH) - FDA approved implant and delivery system
• Spring Implant
• BREEZE Pivotal Clinical Trial

Products and services

• Zenflow Spring Implant and Delivery System FDA-approved minimally invasive implant for treating benign prostatic hyperplasia (BPH) in men. The self-expanding nitinol implant is delivered through a fully flexible scope with a balloon-anchor delivery system and HD visualization, available in three size options for precise anatomical fit. The procedure requires no piercing, cutting, heating, or tissue removal, is fully reversible, and has demonstrated 0% surgical reintervention through 12 months, 0% device/procedure-related SAEs, 99% no post-procedure catheter, and 100% sexual function preservation in clinical trials.
• Single-Use Cystoscope FDA 510(k)-cleared first-of-its-kind single-use cystoscope used in conjunction with the Zenflow Spring Implant and Delivery System to enable the minimally invasive BPH treatment procedure.

Quantifiable outcome

• 62% responder rate at 1 year with mean IPSS improvement of 37% (9 points)
• +7 more outcomes

Segments3 records

Ideal customer profiles2 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature5 records

Partnerships

One partnership is on record.

• Stanford Byers Center for BiodesignfoundationalStrategic or Co-development Partner · 1 January 2014Zenflow was founded out of the Stanford Byers Center for Biodesign. The company states it was designed at Stanford Biodesign, reflecting deep origins in the Stanford innovation ecosystem. The Stanford Byers Center for Biodesign has helped innovators impact over a million patients, with Zenflow founders Shreya Mehta and Nick Damiano featured in its 'Million+ Patients Helped' program.

Scale indicators10 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• Teleflex: Teleflex acquired NeoTract and markets the Urolift System, a leading minimally invasive BPH implant. Urolift is the most established mechanical implant competitor to Zenflow's Spring and directly competes for the same urologist customers and BPH patient population.
• Procept BioRobotics: Procept BioRobotics markets Aquablation, a robotic waterjet BPH treatment. As a fellow private/early-commercial minimally invasive BPH therapy company, it is one of the closest comparable growth-stage urology device businesses competing for the same first-line interventional therapy market.

Broad incumbents

• Boston Scientific: Boston Scientific acquired NxThera and markets the Rezum System, a minimally invasive steam-based BPH treatment, and also acquired Lumenis. As a major urology incumbent with established sales channels and reimbursement infrastructure, it competes broadly for BPH patients and urologist mindshare.
• Olympus: Olympus acquired Medi-Tate and markets the iTind device, a temporarily implanted nitinol BPH treatment that is structurally similar to Zenflow's Spring. Olympus is also a major player in urology visualization (cystoscopes) used in BPH procedures, competing across both device and capital equipment categories.

Emerging players

• Sonablate: Sonablate markets high-intensity focused ultrasound (HIFU) for BPH and other conditions. As another minimally invasive BPH therapy alternative, it represents an emerging non-implant treatment option competing for the same interventional therapy positioning.
• HistoSonics: HistoSonics is developing histotripsy (focused ultrasound tissue destruction) for prostate applications. While earlier stage, it represents a future non-invasive BPH treatment option that could compete with Zenflow's interventional positioning.

Others

• Cook Medical: Cook Medical led Zenflow's Series C financing and is a major urology and medical device manufacturer. As a strategic investor and adjacent urology player, Cook provides both capital and potential strategic partnership/incumbent competitive dynamics relevant to Zenflow's commercialization.
• F-Prime Capital: F-Prime Capital is a healthcare-focused venture firm that has invested in both Zenflow and multiple other medical device companies. While not a direct competitor, F-Prime's portfolio includes urology and surgical device companies that are thematically comparable to Zenflow.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks5 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/zenflowinc
• Facebookfacebook.com/zenflowinc
• Xx.com/zenflowinc

Compliance2 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles8 records

Funding overview

Funding rounds9 records

Investors19 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Zenflow