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Our Story
We are a women's health company on a mission to eliminate bladder leaks and improve pelvic floor health. We were founded by an international team of physicians and medical device professionals. Our vision is to significantly improve the lives of people who suffer from pelvic floor disorders through novel, easy-to-use products backed by strong clinical evidence.
We are working to expand conservative treatment options that inspire women to treat conditions rather than cope with symptoms. We believe that women deserve safe, effective, clinically proven products to treat common problems like urinary incontinence.
17 million American women suffer from stress urinary incontinence. Most are undiagnosed and untreated. This needs to change.
Our first product, Flyte®, is a simple, effective, affordable in-home treatment designed to treat weakened pelvic floor muscles to reduce bladder leaks and restore continence in women suffering from stress urinary incontinence.
Flyte® uses a unique, proprietary technology capable of delivering mechanotherapy, which is a proven method for healing and strengthening muscle systems.¹ Mechanotherapy has not been used to target pelvic floor muscles until now.
After a successful Pilot study in Norway, we sponsored the P-SUIT Trial, one of the largest multi-center randomized, double-blind study for an in-home product designed to treat incontinence. The P-SUIT trial was initiated in March 2017 and completed enrollment in September 2019. Flyte® received FDA clearance in July 2020 for OTC and prescription sales.
We're developing products that leverage the body's natural process to heal and restore the pelvic floor through mechanotherapy.
Flyte® will be evaluated in additional pelvic floor disorders in the future.
Flyte Milestones
2000s: Product Concept Development & Validation
Flyte's® technology was developed in Norway in the 2000s through a partnership between the Arctic University of Norway in Tromso and Ergotest, a company providing training equipment and protocols to professional athletes.
2015: Norway Clinical Trial Completed
A 60-person, single-center study was completed at the Arctic University of Norway. Results showed that Flyte® significantly reduced urinary leaks in women. Findings were published in the peer-reviewed journal Acta Obstetrica et Gyncologica Scandinavia.
2016: Company Founding
We were established as a privately held company in Minneapolis, Minnesota, in the heart of Medical Alley. We acquired the rights to the technology and our Norwegian founders serve on our board and provide day-to-day support.
2019: US Clinical Trial Completed
At 119 patients, our P-SUIT trial was one of the largest multi-center, randomized, double-blind studies of its kind in a home-use SUI device. Between P-SUIT and our Norway study, more than 170 patients were treated using Flyte®; most patients were dry or near dry after 2 - 12 weeks of treatment.
2020 & 2021: FDA 510(k) Clearance & Limited Market Release
Flyte® was cleared for release in 2020 and was launched commercially in 2021.
Available Positions
Position #1Here is a short description of the open position.
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