Pelvalon’s Eclipse™ System Reviewed in Journal of Medical Devices: Evidence and Research

Analysis Reinforces Growing Body of Literature Supporting New
Non-Surgical Therapy for Immediate Bowel Control

SUNNYVALE, Calif.–(BUSINESS WIRE)–Pelvalon, a medical device company dedicated to developing innovative
solutions for women suffering from loss of bowel control, today
announced publication of a peer-reviewed
analysis of the company’s Eclipse™ System in The Journal of
Medical Devices: Evidence and Research.

Eric R. Sokol, M.D., co-chief of Urogynecology and Pelvic Reconstructive
Surgery and associate professor at Stanford University School of
Medicine, is the author of the review, titled “Management of fecal
incontinence – focus on a vaginal insert for bowel control.”

In his analysis, Dr. Sokol discusses the limitations of existing
therapies for treating accidental bowel leakage (ABL), and the unmet
need for effective and minimally invasive treatments. In addition, Dr.
Sokol provides an overview of the design evolution of the Eclipse
System, data from multiple studies of Eclipse, including feasibility
studies and the results of the LIFE clinical trial, which demonstrated
the device’s safety and effectiveness.

“ABL is a devastating condition for women with few effective options,”
said Dr. Sokol. “A novel concept, the Eclipse System offers a
noninvasive option for women suffering from loss of bowel control.
Multiple feasibility studies and a pivotal study have demonstrated the
potential for the insert to offer immediate effectiveness with minimal
risk and a positive impact on quality of life.”

“We are grateful for Dr. Sokol’s thorough review of the Eclipse System,”
said Miles Rosen, co-founder and CEO of Pelvalon. “Given that Eclipse is
the first device of its kind, we have placed a strong emphasis on
clinical research and development, and Dr. Sokol’s analysis neatly
describes the full body of evidence.”

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.

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. In a clinical trial of women who used the insert for one
month, Eclipse was effective in 86% of those successfully fit with the
insert. The most common adverse event was discomfort, most frequently
associated with the fitting process and typically resolved by just
removing the insert. At the end of the study, 96% of participants
successfully fit with the insert found the Eclipse to be comfortable,
and 98% reported that they would recommend it to a friend.

Pelvalon recently announced limited U.S. commercial availability of the
system following U.S. Food and Drug Administration (FDA) 510(k)
clearance for the company’s next-generation device.

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. For more information,
visit www.eclipsesystem.com.

Contacts

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