Watkins-Conti Products, Inc, a company that develops innovative and accessible solutions for women’s pelvic health, has officially secured 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Yōni.Fit® Bladder Support (“Yōni.Fit®”) device. According to certain reports, the Yōni.Fit device comes decked up with an ability to manage urine leakage caused by stress urinary incontinence (SUI) in women aged 18 years and older. Talk about the given product on a slightly deeper level, we must begin from the fact that is manufactured in the US with 100% medical-grade silicone. Once out of manufacturing, Yōni.Fit basically brings to the fore a soft vaginal insert that reduces urine leaks without interfering in voluntary urination. Meant to be a self-administered technology, the stated device can be used during a specific activity or up to 12 hours for general control over symptoms. Despite its innate technological prowess, though, the FDA approval for Yōni.Fit only came after a a randomized, controlled, single blind, multi-center study, which had a total of fifty-eight participants. Conducted by urogynecologists at Stanford, NYU Langone, and Jefferson Health, the study quickly revealed how a significantly higher percentage of women experience meaningful reduction in 12-hour pad weights with the Yōni.Fit® device, as compared to the control device. Furthermore, even if we shift our focus towards the participants who experienced some adverse reactions, the severity of the same was adjudged as no more than mild to moderate level.
“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.”
In order to understand the significance of such a development, though, we must take into account that nearly 2 in every 3 women across US experience stress urinary incontinence at some point in their lives, thus negatively impacting their quality of life and emotional well-being.
Anyway, the move from Watkins-Conti Products also arrives on the back of a $10 million funding round, which will support the company’s bid to create a quality management system, protect the company’s robust intellectual property portfolio, conduct comprehensive clinical trials, deliver biocompatibility and toxicology testing on the devices, as well as expand the executive team and expert advisors.
“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,” 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 Yōni.Fit® device as a self-care platform that could potentially include diagnostics and drug delivery.”