EDMOND-BASED WOMEN'S HEALTHCARE COMPANY, WATKINS-CONTI, LAUNCHES FDA-CLEARED THE YŌNI.FIT® IN OKLAHOMA
Groundbreaking Women's Pelvic Health Device Available in Partnership with Local Healthcare Providers, including Lakeside Doctors and Urogynecology of Oklahoma
EDMOND, Okla., Aug. 26, 2024 /PRNewswire/ -- Watkins-Conti Products, Inc. ("Watkins-Conti"), an Edmond-based leader in women's pelvic health solutions, announces the official launch of the Yōni.Fit® Bladder Support ("Yōni.Fit®"), starting immediately with its home market in Oklahoma and national distribution anticipated in the fourth quarter, following its recent 510(k) clearance from the U.S. Food and Drug Administration (FDA).
The Yōni.Fit® and its FDA clearance represents a substantial milestone as a non-surgical option for the temporary management of stress urinary incontinence (SUI) in women aged 18 and older. Urinary incontinence is a condition that is estimated to affect about 2 in 3 women in the U.S. at some point in their lives, negatively impacting quality of life and emotional well-being.
The Yōni.Fit® is available by prescription starting Aug. 26 through primary healthcare providers and may be covered by insurance. Watkins-Conti has strategically partnered with several esteemed Oklahoma City healthcare providers, including Lakeside Doctors and Urogynecology of Oklahoma, where the product is launching. Additional collaborations with Variety Care and Mercy are also underway, with Thrifty Pharmacy currently as the company's first local pharmacy partner.
"Lakeside holds a special place in my heart. It's where I delivered both of my children, and the challenges I faced after my second delivery directly inspired the creation of the Yōni.Fit®," said Allison L. Watkins, founder and CEO of Watkins-Conti. "Bringing this product to market in partnership with Lakeside is a full-circle moment. We are thrilled to launch the Yōni.Fit® first in Oklahoma and work alongside such respected healthcare and pharmacy institutions."
"Educating providers about the Yōni.Fit® has been incredibly rewarding. Providers are excited to hear that they will now have an FDA approved, accessible way to treat stress urinary incontinence in the office," said Dr. Kate Arnold, Watkins-Conti Chief Medical Officer. "Before the Yōni.Fit®, treatment options were limited in what OBGYNs and family medicine providers could do. Now, providers can prescribe the Yōni.Fit® to treat patients immediately without the need for additional appointments or invasive procedures. Providers are excited to help women reclaim their lives."
Patients looking to obtain the Yōni.Fit® can schedule appointments at Lakeside Doctors, Urogynecology of Oklahoma or Mercy, and once prescribed can pick up at one of two Thrifty Pharmacy locations.
"I look forward to having this new solution for my patients who leak urine with exercise, laughing, or coughing," said Dr. Dana Stone, OBGYN, Lakeside Doctors. "Controlling urine loss gives women back their confidence and favorite activities."
"I understand that the more informed the patient is, the better decisions they can make about their health," said Dr. Arielle Allen, Urogynecology Female Pelvic Medicine at INTEGRIS Health and Urogynecology of Oklahoma. "As a urogynecologist specializing in female pelvic medicine, I am looking forward to having another non-invasive, FDA-cleared option for women experiencing stress urinary incontinence."
The Yōni.Fit® is crafted in the U.S. from 100% medical-grade silicone. This soft, flexible vaginal insert effectively reduces urine leaks without inhibiting voluntary urination. It is self-administered and can be used during specific activities, after recently giving birth, going through menopause, or for up to 12 hours for broad symptom management.
"I already have a patient ready for this…just saw her last week and as soon as we have it, she will be ready for her device," said Lydia D. Nightingale, MD, Vice President Medical Affairs at Variety Care. "She wants it for when she plays pickleball. Can't wait! This will be so great for the women of Oklahoma (and others as well)."
"This product not only provides an alternative and convenient solution, but also one that is accessible to a diverse range of women," Arnold said.
The Yōni.Fit® is thoughtfully designed to comfortably and effectively meet the needs of women of all shapes and sizes, as well as women residing in rural areas and medically underserved communities, for whom access to surgical treatments may be challenging. By providing a convenient, non-invasive solution, the Yōni.Fit® ensures that more women can manage their pelvic health effectively, regardless of their geographic location or healthcare access limitations.
Dani Lynch, Owner, Thrifty Pharmacy said, "We are excited to partner with Watkins-Conti Products, and to be the first pharmacy provider for the Yōni.Fit® in the state of Oklahoma. We have worked with and followed Allison Watkins through the years of development and it's great to see her dream of helping women with incontinence problems finally come true. The Yōni.Fit® will be available by prescription only at both of our Thrifty Pharmacy locations at 10904 N. May in Oklahoma City, and 230 S. Santa Fe in Edmond."
The launch of the Yōni.Fit® follows a rigorous randomized, controlled, single-blind, multi-center clinical study, and was conducted by urogynecologists at top medical centers, including Stanford Health Care, NYU Langone, and Thomas Jefferson Health. Results showed a significant reduction in 12-hour pad weights among users of the Yōni.Fit® compared to a control device, with mild to moderate adverse events reported and no serious adverse events related to the product. Further ongoing support, including plenary sessions at scientific conferences, was provided by the American Urogynecologic Society (AUGS) and Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction (SUFU). An abstract of the study can be found online at ClinicalTrials.gov.
"My lived experience as a new mother with SUI gave me the inspiration for the Yōni.Fit®," Watkins said. "The options available at the time did not suit my needs as a working mom with two small children. Listening to patients and innovating accordingly is at the heart of what we do at Watkins-Conti. We are committed to developing innovative, accessible solutions for women's pelvic health, with the Yōni.Fit® as a cornerstone of that mission."
For more information and details about the Yōni.Fit®, visit Yōni.Fit.com.
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, the Yōni.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.
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SOURCE Watkins-Conti Products, Inc.
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