Market Overview

Renovia Supports ACOG and WPSI Recommendations Related to Screening for Urinary Incontinence


Renovia is Developing a Product Pipeline to Better Diagnose and Treat
Women Affected by Pelvic Floor Disorders, including Urinary Incontinence

Renovia Inc. ("Renovia"), a company dedicated to discovering and
delivering first-line digital therapeutic and diagnostic devices for
women with pelvic floor disorders, today shared its strong support for
new recommendations for screening for urinary incontinence outlined by
The American College of Obstetricians and Gynecologists ("ACOG") and the
Women's Preventive Services Initiative ("WPSI").

In May 2018, ACOG released an opinion outlining the need for a
comprehensive approach to postpartum care in order to optimize long-term
health of mothers. As part of Committee
Opinion No. 736
, ACOG recommends postpartum care should involve a
full assessment of a woman's physical, social and psychological
well-being, including screening for pelvic floor disorders such as
urinary incontinence.

Further, WPSI, a national coalition led by ACOG, consisting of 21 health
professional organizations and patient representatives, released the
first established screening guidelines for detecting urinary
incontinence in women in the U.S., recommending routine screening for
all women beginning in adolescence. According to the WSPI
, which were published on August 14, 2018, early detection
of urinary incontinence symptoms is needed to encourage women to seek
viable treatment options.

"The ACOG Committee Opinion and the WSPI screening recommendations are
both so well aligned with Renovia's commitment to awareness and
first-line treatment," said Samantha Pulliam, MD, Chief Medical Officer
at Renovia. "Both recommendations support a call-to-action related to
female pelvic health, and we are excited for the positive health impact
they can have for millions of women who experience urinary incontinence
and other pelvic floor disorders."

Urinary incontinence affects an estimated 20 million women in the U.S.1
and an estimated 250 million women worldwide.2 In addition to
its negative impact on quality of life, urinary incontinence can lead to
severe medical conditions, such as urinary tract infections and skin
ulcerations. Despite its high rates and adverse effects on women's
health, urinary incontinence is often underreported by women and not
recognized by clinicians. However, early intervention has been shown to
resolve or reduce symptoms, improve immediate and long-term
condition-specific quality of life, and limit the need for more invasive
and costly treatments.

Jessica McKinney, PT, Renovia's Vice President of Medical Affairs and
Clinical Advocacy, added, "These two strong statements recognize the
importance of women's health issues, particularly pelvic health. Too
often urinary incontinence is a silent disorder women are hesitant to
discuss. Recommendations from leading organizations like ACOG and the
WPSI are critical to bringing these sensitive issues to the forefront."

Through its proprietary medical device technology and app enabled
visualization of pelvic movement, Renovia is developing a product
pipeline with the potential to better diagnose and treat women affected
by urinary incontinence and other pelvic floor disorders. Renovia's
existing FDA-cleared device, the leva® Pelvic Digital Health
System, is indicated for strengthening pelvic floor muscles, and
indicated for treating stress, mixed and mild to moderate urgency
urinary incontinence in women. The leva device and Renovia's full
product pipeline all leverage state-of-the-art patient-based apps and
data management technology to provide precise, cost-effective treatment
of weakened pelvic floor muscles in real-time, while collecting
actionable compliance and progress data on women's pelvic health.

About Renovia

Renovia was formed to develop and commercialize products for better
first-line diagnosis and treatment to improve the condition-specific
quality of life for millions of women with pelvic floor disorders.
Renovia's technology enables treatment via precise visualization of
pelvic movement in real time during pelvic floor muscle training, while
monitoring usage and progress over time. As a women's health
organization, Renovia is in pursuit of scalable and cost-effective care
for pelvic floor disorders delivered through the power of digital
health. For more information, please visit here.

1 Wu, J. M., Hundley, A. F., Fulton, R. G., & Myers, E. R.
(2009). Forecasting the Prevalence of Pelvic Floor Disorders in U.S.
Women. Obstetrics & Gynecology, 114(6), 1278–1283.
Irwin D.E., Kopp Z.S., Agatep B., Milsom I., & Abrams P. (2011).
Worldwide prevalence estimates of lower urinary tract symptoms,
overactive bladder, urinary incontinence and bladder outlet obstruction
in British Journal of Urology, 108(7):1132-8.

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