DEI - WOMEN'S HEALTHCARE COMPANY WATKINS-CONTI RECEIVES FDA 510(K) CLEARANCE FOR NEW STRESS URINARY INCONTINENCE DEVICE Y?NI.FIT®

PR Newswire

Company is Poised to Participate in $4B U.S. Adult Urinary Incontinence Market

EDMOND, Okla. , May 17, 2024 /PRNewswire/ -- Watkins-Conti Products, Inc. ("Watkins-Conti"), 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 Y?ni.Fit ^® Bladder Support ("Y?ni.Fit ^® "). Y?ni.Fit ^® is intended for the temporary management of urine leakage caused by stress urinary incontinence (SUI) in women, 18 years and older.

Manufactured in the U.S. with 100% medical-grade silicone, Y?ni.Fit ^® is a soft vaginal insert that reduces urine leaks without interfering with voluntary urination. Y?ni.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 Y?ni.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 Y?ni.Fit ^® clinical study. "The cost and downtime associated with surgery can be prohibitive for some women."

"My lived experience as a new mother with SUI gave me the inspiration for Y?ni.Fit ^® . The options available to me at the time did not complement my lifestyle as a working mom with two small children," said Allison L. Watkins , founder and CEO of Watkins-Conti. "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 Y?ni.Fit ^® device as a self-care platform that could potentially include diagnostics and drug delivery."

Fifty-eight (58) participants were enrolled in a randomized, controlled, single blind, multi-center study of Y?ni.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 Y?ni.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 Y?ni.Fit ^® .

"I believe Y?ni.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."

"With this FDA clearance, Watkins-Conti is now positioned to help this important and underserved market," said Ross Watkins , president of Watkins-Conti.

Y?ni.Fit ^® will be available with a prescription from a primary healthcare provider and may be covered by insurance. Product information is available at Y?ni.Fit.com .

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.

About Watkins-Conti Products, Inc.
Founded by entrepreneur and inventor Allison L. Watkins , Watkins-Conti is an American healthcare company that develops innovative and accessible solutions for women's pelvic health. Watkins-Conti is developing a pipeline of treatments and diagnostics that address women's reproductive, sexual, and pelvic health — with the ultimate goal of getting women everywhere the care they deserve. The company's flagship product, Y?ni.Fit ^® , is the first patient-designed, non-surgical device designed to relieve the symptoms of stress urinary incontinence. Based in Edmond, Oklahoma , Watkins-Conti holds numerous utility patents, design patents, and trademarks in the U.S. and abroad. For more information, visit WatkinsContiProducts.com and LinkedIn .

Media Contact:
Anthony Triana
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SOURCE Watkins-Conti Products, Inc.