CORRECTING and REPLACING Axena Health Receives Two Additional Positive Insurance Coverage Decisions for Leva
July 05 2024 - 11:00AM
Business Wire
Two of the largest health plans in Pennsylvania
and North Dakota now cover the Leva Pelvic Health System for women
seeking effective treatment for urinary incontinence
Please replace the release issued April 11, 2024 with the
following corrected version due to multiple revisions.
The updated release reads:
AXENA HEALTH RECEIVES TWO ADDITIONAL
POSITIVE INSURANCE COVERAGE DECISIONS FOR LEVA
Two of the largest health plans in Pennsylvania
and North Dakota now cover the Leva Pelvic Health System for women
seeking effective treatment for urinary incontinence
Axena Health, Inc. (Axena Health), a medical device company
focused on female pelvic health, announced today that two of the
largest health plans in Pennsylvania and North Dakota have added
the Leva® Pelvic Health System as a covered benefit for their
members suffering with urinary incontinence. Both positive coverage
decisions became effective on April 1, 2024.
The Leva Pelvic Health System (HCPCS Level II code, S9002) is a
small, flexible intra-vaginal probe, embedded with multiple
accelerometer motion sensors, that communicates with the patient
via integrated software to provide guidance during pelvic floor
muscle treatment. Affecting 62% of adult women in the U.S., urinary
incontinence (UI) is a progressive disorder that typically worsens
without treatment. Untreated, UI can severely impact a woman’s
quality of life and lead to significant negative comorbidities. The
Leva System is U.S. Food and Drug Administration (FDA)-cleared to
treat stress, mixed and mild-to-moderate urgency UI (including
overactive bladder) in women. It is also FDA-cleared for the
first-line treatment of chronic fecal incontinence in women. The
Leva System is available by prescription only, ensuring clinicians
remain directly engaged with patients’ care. It requires just five
minutes of use per day, typically over eight to twelve weeks, which
women can do at home, on their own schedule.
“Pelvic floor disorders such as stress urinary incontinence and
pelvic organ prolapse can negatively impact the quality of your
life and are becoming more common,” stated Vincent Lucente, MD,
MBA, FACOG, URPS and the Physician Leader for Urogynecology at The
Institute for Female Pelvic Medicine and Reconstructive Surgery an
Axia Women’s Health care center. “While pelvic floor muscle
strengthening is an effective first-line treatment, properly
recruiting, coordinating, and activating the correct muscle can be
difficult to perform. However, Leva enables me to prescribe this
proven intervention with confidence. Recently published
peer-reviewed data show women can use Leva successfully to treat
incontinence. Most importantly, they can do it in the privacy of
their home, and on their own schedule. Leva also gives me the
option to stay involved in their therapy, which further supports
success. Insurance coverage is essential to ensuring that more
women can access effective treatment, and I applaud these health
plans for their commitment to women’s pelvic floor health.”
“On behalf of the millions of women who now have improved access
to UI treatment without medications or surgery, I’d like to thank
these two health plans for recognizing the compelling studies
supporting the Leva System’s effectiveness,” said Samantha J.
Pulliam, M.D., chief medical officer for Axena Health. “Axena
Health is focused on providing evidence-based solutions through
both formal clinical trials with world-class academic institutions
and published real-world evidence. Women deserve better treatment
options, including those who don’t have local access to specialists
in pelvic floor care. The Leva System helps enable improved
treatment regardless of the location of the patient and their
clinician.”
“Insurance coverage equals access for most women in the U.S.,”
said Axena Health’s interim CEO Jim O’Connor. “Two more positive
coverage decisions for the Leva System means more women can access
effective, first-line treatment for UI. No woman living with
bladder leaks should feel that her only options are drugs, surgery,
or a lifetime of adult incontinence pads. Our most recent published
study shows that just eight weeks of at-home treatment with the
Leva System results in two years of clinically significant symptom
improvement, which makes the Leva System uniquely valuable for
women living in rural areas where specialized care is hard to
access. These two innovative health plans have joined Cigna in
demonstrating their clear commitment to women’s health. I am
excited for other payers to follow their lead.”
About the Leva® Pelvic Health System
The Leva® Pelvic Health System offers an innovative,
non-invasive, medication-free way for women to train and strengthen
their pelvic floor muscles—at home in just five minutes a day—to
treat urinary incontinence (UI) and chronic fecal incontinence
(FI). Combining a small FDA-cleared vaginal motion sensor with
integrated software, the Leva System offers precise visualization
of pelvic movement in real-time, enables progress tracking and
allows active physician involvement, all of which support women’s
success. Recognizing that level-one evidence shows pelvic floor
muscle training is most effective when performed under the
supervision of a skilled healthcare provider, the Leva System is
available by prescription only, allowing physicians the opportunity
to treat UI and chronic FI on a broad scale and with continued
involvement in patient success. The Leva System has multiple
clinical trials and published data from globally recognized medical
centers supporting its efficacy in treating UI, including two
studies in Obstetrics and Gynecology (The Green Journal), the
official publication of the American College of Obstetricians and
Gynecologists (ACOG).
About Axena Health
Axena Health, Inc. is dedicated to improving the lives of women
with pelvic floor disorders. Axena Health’s flagship product, the
Leva® Pelvic Health System, offers a novel, effective, first-line
treatment for urinary incontinence (UI) and chronic fecal
incontinence (FI), underreported conditions affecting over 78
million and 12 million women in the U.S. alone. Axena Health's
technology enables non-invasive, drug-free treatment via precise
visualization of movement in real time during pelvic floor muscle
training, while monitoring usage and progress. For more
information, please visit www.axenahealth.com or
www.levatherapy.com and follow Axena Health on LinkedIn.
Important Indication and Other Information for the Leva®
Pelvic Health System
The Leva® Pelvic Health System is intended for (1) strengthening
of pelvic floor muscles, (2) rehabilitation and training of weak
pelvic floor muscles for the treatment of stress, mixed, and mild
to moderate urgency urinary incontinence (including overactive
bladder) in women and (3) rehabilitation and training of weak
pelvic floor muscles for the first-line treatment of chronic fecal
incontinence (>3-month uncontrolled
passage of feces) in women. Treatment with the Leva System is by
prescription and is not for everyone. Please talk to your
prescriber to see if Leva System is right for you. Your prescriber
should discuss all potential benefits and risks with you. Do not
use Leva System while pregnant, or if you think you may be
pregnant, unless authorized by your doctor. For a complete summary
of the risks and instructions for the Leva System, see its
Instructions for Use available at www.levatherapy.com.
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