Watkins-Conti 'Yōni.Fit' obtains FDA clearance for bladder leakage device

The Yōni.Fit® silicon device is intended for the temporary management of urine leakage caused by stress urinary incontinence (SUI) in women

Watkins-Conti Products Inc, a company that develops innovative and accessible solutions for women's pelvic health, has obtained 510(k) clearance from the U.S. Food and Drug Administration (FDA) for Yōni.Fit^® Bladder Support.

The Yōni.Fit is a silicon medical-grade device that is a fast and easy way to stop bladder leaks instantly. It is intended for the temporary management of urine leakage caused by stress urinary incontinence (SUI) in women, 18 years and older.

Manufactured in the US, the soft vaginal insert reduces urine leaks without interfering with voluntary urination. Yōni.Fit is self-administered and can be used during a specific activity or up to 12 hours for general control over symptoms.

The FDA clearance represents a substantial milestone in non-surgical options for the temporary management of urinary incontinence, a condition that is estimated to affect about 2 in 3 women in the United States at some point in their lives, negatively impacting quality of life and emotional well-being.

"In my clinical practice, women who experience urine leakage feel they have limited treatment options and desire an alternative to surgery or adult pads," said Eric R. Sokol, MD, Associate Professor of Obstetrics and Gynecology at Stanford Health Care and an investigator in the Yōni.Fit clinical study.

"My patients with stress urinary incontinence want a solution that is effective and convenient – one that accommodates the reality of their busy lives and does not interfere with voluntary urination," said Karolynn T. Echols, MD, Director and Associate Professor of Female Pelvic Medicine and Reconstructive Surgery at Thomas Jefferson University and an investigator in the Yōni.Fit^® clinical study. "The cost and downtime associated with surgery can be prohibitive for some women."

The company was founded by Allison L Watkins. Allison said:

"My lived experience as a new mother with SUI gave me the inspiration for Yōni.Fit. The options available to me at the time did not complement my lifestyle as a working mom with two small children."

"Listening to patients on their journey and innovating accordingly is paramount. I am committed to developing even more solutions for women's pelvic health, using the Yōni.Fit device as a self-care platform that could potentially include diagnostics and drug delivery."

The Yoni.Fit study

A total of 58 participants were enrolled in a randomized, controlled, single blind, multi-center study of Yōni.Fit in women with SUI. The study was conducted by urogynecologists at Stanford, NYU Langone, and Jefferson Health.

Of the participants completing the evaluation phase, a significantly higher percentage experienced clinically meaningful reduction in 12-hour pad weights with the Yōni.Fit device compared to the control device. 

Among study participants experiencing adverse events, the severity was mild to moderate; there were no serious adverse events related to Yōni.Fit.

"I believe Yōni.Fit will be an appealing and effective self-care solution for patients who value convenience and want to be in control of their pelvic health," said Kate C. Arnold, MD, Chief Medical Officer of Watkins-Conti.

"We are committed to helping all women, including those in rural areas and in medically underserved communities, where access to surgery would be challenging."

Yōni.Fit will be available with a prescription from a primary healthcare provider and may be covered by insurance.

The company has raised nearly $10M from angel investors and VCs. The funds have been directed towards creating a quality management system, protecting the company's robust intellectual property portfolio, conducting clinical trials, biocompatibility and toxicology testing on the devices, and expanding the executive team and expert advisors.