Company is Poised to Participate in $4B U.S. Adult Urinary Incontinence Market
EDMOND,
Okla., May 17, 2024 /PRNewswire/ -- Watkins-Conti
Products, Inc. ("Watkins-Conti"), a company that develops
innovative and accessible solutions for women's pelvic health, has
obtained 510(k) clearance from the U.S. Food and Drug
Administration (FDA) for Yōni.Fit® Bladder Support
("Yōni.Fit®"). Yōni.Fit® is intended for the
temporary management of urine leakage caused by stress urinary
incontinence (SUI) in women, 18 years and older.
Company is Poised to Participate in
$4B U.S. Adult Urinary Incontinence
Market
Manufactured in the U.S. with 100% medical-grade silicone,
Yōni.Fit® is a soft vaginal insert that reduces urine
leaks without interfering with voluntary urination.
Yōni.Fit® is self-administered and can be used during a
specific activity or up to 12 hours for general control over
symptoms. The FDA clearance represents a substantial milestone in
non-surgical options for the temporary management of urinary
incontinence, a condition that is estimated to affect about 2 in 3
women in the United States at
some point in their lives, negatively impacting quality of life and
emotional well-being.
"In my clinical practice, women who experience urine leakage
feel they have limited treatment options and desire an alternative
to surgery or adult pads," said Eric R.
Sokol, MD, Associate Professor of Obstetrics and Gynecology
at Stanford Health Care and an investigator in the
Yōni.Fit® clinical study.
"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."
"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."
Fifty-eight (58) participants were enrolled in a randomized,
controlled, single blind, multi-center study of
Yōni.Fit® in women with SUI. The study was
conducted by urogynecologists at Stanford, NYU Langone, and Jefferson Health. Of the
participants completing the evaluation phase, a significantly
higher percentage experienced clinically meaningful reduction in
12-hour pad weights with the Yōni.Fit® device compared
to the control device. Among study participants
experiencing adverse events, the severity was mild
to moderate; there were no serious adverse events
related to Yōni.Fit®.
"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."
"With this FDA clearance, Watkins-Conti is now positioned to
help this important and underserved market," said Ross Watkins, president
of Watkins-Conti.
Yōni.Fit® will be available with a prescription from
a primary healthcare provider and may be covered by insurance.
Product information is available at Yōni.Fit.com.
The company has raised nearly $10M
from angel investors and VCs. The funds have been directed towards
creating a quality management system, protecting the company's
robust intellectual property portfolio, conducting clinical trials,
biocompatibility and toxicology testing on the devices, and
expanding the executive team and expert advisors.
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,
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.
Media Contact:
Anthony Triana
atriana@saxum.com
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SOURCE Watkins-Conti Products, Inc.