Company Obtains FDA Clearance for Yōni.Fit® Bladder Support in U.S. Adult Urinary Incontinence Market
Watkins-Conti Products, Inc., a company dedicated to developing innovative solutions for women’s pelvic health, has recently received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for their Yōni.Fit® Bladder Support device. This milestone achievement allows the company to enter the $4 billion U.S. adult urinary incontinence market.
Yōni.Fit® is a soft vaginal insert made with 100% medical-grade silicone that helps reduce urine leaks caused by stress urinary incontinence (SUI) in women aged 18 and older. The device can be self-administered and used during specific activities or for up to 12 hours for general symptom control. This FDA clearance represents a significant advancement in non-surgical options for managing urinary incontinence, a condition that affects about 2 in 3 women in the United States at some point in their lives.
Clinical studies conducted with Yōni.Fit® have shown promising results, with a higher percentage of participants experiencing a reduction in urine leakage compared to the control device. The device has also been well-tolerated, with no serious adverse events reported.
Founder and CEO of Watkins-Conti, Allison L. Watkins, shared that her personal experience as a new mother with SUI inspired the development of Yōni.Fit®. She emphasized the importance of listening to patients’ needs and innovating accordingly to provide effective and convenient solutions for women’s pelvic health.
With the support of angel investors and venture capitalists, Watkins-Conti has raised nearly $10 million to further develop their product line, conduct clinical trials, and expand their team. Yōni.Fit® will be available with a prescription from healthcare providers and may be covered by insurance.
Watkins-Conti is committed to providing accessible and effective solutions for women’s pelvic health, with a focus on improving the quality of life for those affected by urinary incontinence. For more information about Watkins-Conti Products, Inc. and their innovative solutions, visit WatkinsContiProducts.com.
