Our Story

Cheri’s Promise to Her Grandmother

When I was five years old, my twin and I would go to visit my grandmother’s family in the nursing home. I remember the smell of urine was overwhelming. I would look in to the rooms as we passed through seeing all the older people wearing diapers. I thought to myself, “why are they wearing diapers and I am not?”

I remember tugging on my grandmother’s dress telling her, “One day, I am going to help these people.” She whispered in my ear, “Good, Honey. They are going to need it!”

To this day, I am fascinated by catheters and how they are made. Why do people need them and other medical devices that are used in the body? My grandmother has since passed away. When she passed, everyone released Monarch butterflies at her funeral. When I look at our logo, it reminds me of the promise I gave her.

Our Vision

Our vision is to offer women worldwide a convenient alternative for the treatment of stress urinary incontinence (SUI). Floelle intends to become the leader in female pelvic health.

Our Mission

Our mission is to liberate women from the embarrassment, insecurity, and cost of using sanitary paper products, external hand-held devices, or surgery, with our by-prescription–only, minimally-invasive, anti-microbial device for the treatment of stress urinary incontinence (SUI).

Milestones

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2019

First Test

Test first subject in Houston, Texas.

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2020

Clinical Research suspended due to Pandemic.

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2021

New Product Redesign

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2022

Receives IRB Approval for new clinical site. 

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2024

Early Feasibility Study

Complete Early Feasibility Study, design for manufacture, raise seed round, begin pivotal clinical trial. 

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2025

Complete pivotal Clinical Trial. Submit data to FDA and EMA. Hire sales, marketing, and clinical training teams. Train distributors’ sales forces. Educate and train doctors. Receive FDA and EMA clearance. 

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2026

First Year of Sales

Begin sales in four regional sales territories (2 US, 2 EU), reaching a market of 240 million women. 

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2027

Second Year of Sales

Second year of sales in four more regions. 

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2028

Third Year of Sales

Third year of sales in all of the US and European regions (12 regions).