Watkins-Conti, a women’s health company dedicated to advancing pelvic health solutions, has achieved a significant milestone with the FDA 510(k) clearance for its device, Yōni.Fit Bladder Support.

Designed and manufactured in the U.S. using 100% medical-grade silicone, Yōni.Fit represents a new approach to addressing SUI without resorting to surgery. The device, designed as a soft vaginal insert, effectively reduces urine leaks while allowing for voluntary urination. It provides women with a convenient, non-surgical option for managing SUI symptoms during daily activities or for up to 12 hours. The FDA clearance underscores Yōni.Fit’s potential to successfully manage SUIs, a condition affecting approximately 2 in 3 women in the United States.

“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 development of Yōni.Fit was inspired by the real-life experiences of Founder and CEO, Allison L. Watkins, who identified a critical need for solutions that align with women’s lifestyles and preferences. Watkins shared: “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.”

A pivotal multi-center study involving 58 participants, led by urogynecologists from leading institutions such as Stanford, NYU Langone, and Jefferson Health, demonstrated Yōni.Fit’s effectiveness in reducing urine leakage.

“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 is expected to offer women greater autonomy over their pelvic health, with potential coverage by insurance. Watkins-Conti is dedicated to ensuring accessibility to its innovative solution, particularly for women in rural and medically underserved communities. Ross Watkins, President of Watkins-Conti, affirmed: “With this FDA clearance, Watkins-Conti is now positioned to help this important and underserved market.”

To date the company has secured nearly $10 million from angel investors and VCs, channeling the funds toward quality management, clinical trials, intellectual property protection, and team expansion.

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