New Publication in Diseases of the Colon & Rectum Shows that Pelvalon’s Eclipse System Improves Symptoms Associated with Loss of Bowel Control

SUNNYVALE, Calif.–(BUSINESS WIRE)–Pelvalon, a medical device company focused on developing innovative
solutions for women suffering from loss of bowel control, today
announced the publication of data in Diseases of the Colon & Rectum, the
journal of the American Society of Colon and Rectal Surgeons. This
analysis demonstrated the impact of the company’s Eclipse™ System on
bowel dysfunction symptoms associated with loss of bowel control, such
as the need to rush to a bathroom.

Originally presented at the Annual Meeting of the American Society of
Colon and Rectal Surgeons (ASCRS) in May 2015, data from the study
showed that use of the Eclipse insert was associated with improved bowel
symptoms and function in women suffering from loss of bowel control
(also known as fecal incontinence). These symptoms can be devastating to
a patient’s quality of life, and women using Eclipse experienced reduced
frequency of bowel movements, reduced urgency (the need to rush to the
bathroom), improved stool consistency (less loose stool) and more
complete evacuation. These data and claims are currently not included in
the FDA-cleared labeling for the device. The study is available online
ahead of print, and will be published in the February 2016 issue of the
publication.

“The symptoms studied in this analysis are contributing to fecal
incontinence, with women restricting their activities and altering their
lives to manage the condition,” said Madhulika G. Varma, M.D., professor
and chief of Colorectal Surgery in the department of Surgery at
University of California-San Francisco Medical Center and lead author of
the study. “The results of the study offer hope, suggesting that the
Eclipse System could substantially improve quality of life for these
women.”

The Eclipse System is the first vaginal insert designed to provide
immediate bowel control. Placed in the same location as a tampon or a
diaphragm, the insert contains no hormones or drugs and can be removed
at any time. The study was conducted at six sites across the United
States, and evaluated 56 women with significant accidental bowel
leakage. The pivotal trial results of the broader LIFE study supported
the FDA clearance of the Eclipse System and were published in Obstetrics
& Gynecology
in February 2015.

“This is the second peer-reviewed publication of data on the Eclipse
System, and the results continue to clearly demonstrate the benefits of
the treatment,” said Miles Rosen, CEO of Pelvalon. “We are gratified by
the growing body of clinical evidence supporting Eclipse as a promising
option for women suffering from this devastating condition.”

More than 20 million women in the U.S. suffer from loss of bowel
control, sometimes called accidental bowel leakage (ABL) or fecal
incontinence (FI). This debilitating condition can be caused by
pregnancy, childbirth, nerve or muscle damage in the pelvic region, and
gastrointestinal disorders such as irritable bowel syndrome (IBS).
Sometimes women will feel a strong urge to have a bowel movement; other
times, leakage can occur without warning. Typical first-line treatments
include dietary changes, exercise and medications. If the issue
persists, patients may need to move on to more invasive and costly
treatments, such as surgery, surgical implants, or injections. The
Eclipse System provides a new, non-surgical option for these women.

About the Eclipse System

Pelvalon’s Eclipse System is placed in the same location as a tampon or
a diaphragm, and can be removed at any time. A hand-held pump is used to
inflate and deflate a balloon on the insert. The balloon is designed to
occlude the rectum to protect against unwanted stool passage. The insert
does not contain drugs or hormones. The first generation of the system
was cleared by the FDA in February 2015 for the treatment of fecal
incontinence in adult women.

About Pelvalon

Headquartered in Sunnyvale, California, privately held Pelvalon aims to
improve the lives of women who suffer from bowel control
problems. Founded in 2010, Pelvalon’s groundbreaking technology
originated from Stanford University’s Biodesign program, a collaboration
between the schools of medicine and engineering.

Contacts

for Pelvalon
Nicole Osmer, 650-454-0505
nicole@nicoleosmer.com