Watkins-Conti Completes Clinical Trial of Stress Urinary Incontinence Device

Watkins-Conti Products Inc. has successfully completed a clinical trial studying the safety and effectiveness of its flagship product, Yōni.Fit, a vaginal insert designed to manage stress urinary incontinence (SUI). 
 
Seventy one (71) participants enrolled in a randomized, controlled, single blind, multi-center study of the Yōni.Fit device in women with SUI. The study was led by urogynecologists at Stanford, NYU Langone, and Jefferson Health. Results from the study are being submitted to a peer-reviewed journal and associated medical conference held later this year. Watkins-Conti will be filing a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) to provide reasonable assurance that the Yōni.Fit device is safe and effective for SUI. The FDA must review the submission and grant 510(k) clearance prior to commercial distribution.
 
“During my career, I have seen how medical innovations developed based on a person’s lived experience can make a meaningful impact in addressing the unique needs or considerations of the patients whom they intend to benefit,” said Nada Hanafi, regulatory strategy advisor at Watkins-Conti. “That is why I am delighted to support the pelvic health initiatives that Watkins-Conti Products is bringing forward to improve health outcomes.”
 
Watkins-Conti also announced the expansion of the Board of Directors and executive team. “Our leadership team represents the breadth of expertise and vision we need to launch our IP-protected pipeline of treatments and diagnostics for which we envision utilizing the Yōni.Fit device as a platform,” CEO Allison L. Watkins stated. “Many women are conditioned to accept discomfort as an unavoidable fact of life. We seek to break that cycle by providing a range of convenient and comfortable solutions that put women in control of their health.”
 
The Board is composed of leaders with expertise across biosciences, health care services, and intellectual property. Allison Watkins (founder and CEO) and Ross Watkins (president) are joined by the board’s newest member, Mike Pintek (president, Nuclear & Precision Health Solutions, Cardinal Health), and Jennie Martel (chief of Global Brand Protection, Colgate-Palmolive), Dr. Anula Jayasuriya (private equity and venture capital executive), and John H. Marmaduke (former retail executive).
 
“We’re in a transformational time for women and women’s health, and I am excited to join the Watkins-Conti Products board to help them address health challenges impacting women,” Pintek said. “The team is passionate about and committed to pioneering important innovative advancements in healthcare, and I look forward to guiding the company as it solidifies its vision.”

The executive team is focused on commercializing the company’s product pipeline. Sean Givens advises the company on financial modeling and forecasting and Hanafi advises the company on regulatory strategy. Hanafi spent nearly 13 years at FDA’s Center for Devices and Radiological Health (CDRH) working on a range of products and devices and helped establish the CDRH Health of Women Program. Neil Luckianow is chief commercialization officer and advises the company on go-to-market strategies, product distribution, and customer engagement. Brooke Wigley is the director of Operations, overseeing the day-to-day functions of the business.
 
SUI is a condition estimated to affect about three in four women worldwide at some point in their lives, negatively impacting quality of life and emotional well-being. SUI may get worse over time if left untreated, and may also contribute to pelvic organ prolapse. 
 
The company has raised more than $6 million from angel investors and venture capitalists. The funds have been directed towards creating quality management systems, protecting the company’s robust intellectual property portfolio, conducting clinical trials, and expanding the executive team and expert advisers.
 
Founded by entrepreneur and inventor Allison L. Watkins in 2016, Watkins-Conti develops solutions for often-overlooked issues affecting women at every stage of life. Watkins-Conti is developing a pipeline of treatments and diagnostics that address women’s reproductive, sexual, and pelvic health. The company’s flagship product, Yōni.Fit, is the first patient-designed, non-surgical device designed to relieve the symptoms of stress urinary incontinence; it will be submitted to FDA for clearance following completion of a national clinical trial by urogynecologists at Stanford, NYU, and Jefferson Health. Based in Edmond, Okla., Watkins-Conti holds numerous utility patents, design patents, and trademarks in the United States and abroad.