First Long-Term Usage Data on Patient Satisfaction With Pelvalon’s Eclipse System to Be Presented at PFD WEEK 2016

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SUNNYVALE, Calif.–(BUSINESS WIRE)–Pelvalon today announced that new data on the Eclipse™ System will be
released at the Pelvic Floor Disorders (PFD) Week 2016, which is taking
place September 28-30 at the Colorado Convention Center in Denver. PFD
Week coincides with the 37th Annual Scientific Meeting of the
American Urogynecologic Society (AUGS), and highlights the importance of
education on pelvic floor disorders, which impact one in three women.

Pelvalon is dedicated to developing innovative solutions for women
suffering from loss of bowel control, a type of pelvic floor disorder.
Often called accidental bowel leakage (ABL) or fecal incontinence (FI),
the condition can be caused by pregnancy, childbirth, nerve or muscle
damage in the pelvic region, and irritable bowel syndrome (IBS) or other
gastrointestinal conditions. Losing bowel control can be debilitating,
causing women who suffer from it to miss work, household productivity,
and social interaction.

New data will be shared on the experience of the first five women to
wear the Eclipse System for longer than 12 months.

“Although there is previously published multi-center evidence of
positive outcomes, this is the first example of long-term use of the
therapy and it is encouraging to see continued patient satisfaction with
the Eclipse System in this small sample,” said study investigator
Michelle Takase-Sanchez, M.D., of Ventura County Obstetric and
Gynecologic Medical Group in Ventura, Calif., who will present the
results.

The five women had worn the device for an average of 18.6 months at the
time of data collection. Their ages ranged from 38 to 73 years, and they
had each suffered from ABL for one to five years, using absorptive pads
to manage symptoms. The patients represented a variety of medical
histories: four participants were post-menopausal, two had previously
undergone hysterectomy, one reported irritable bowel syndrome, and three
women also reported symptoms of urinary incontinence. All reported
ongoing satisfaction with the Eclipse System.

“In the development of any truly novel therapy, it is essential to
understand the patient experience and their enthusiasm for treatment,”
said Miles Rosen, co-founder and CEO of Pelvalon. “This small group of
women provided invaluable feedback about the daily experience of using
the Eclipse System, and we are grateful for their participation in this
ongoing study.”

Dr. Takase-Sanchez’s presentation, titled “Long-Term Safety and
Satisfaction of a Novel Vaginal Bowel Control System for the Treatment
of Accidental Bowel Leakage in Adult Women,” will be on Friday,
September 30 at 10:20 am in Room Four Seasons 4, as part of a session on
Clinic-Based Urogynecology.

Pelvalon’s Eclipse System is a dynamic vaginal device designed to offer
women a non-surgical treatment for loss of bowel control by modulating
the size of the rectal lumen. The device includes a portion that expands
to reduce the rectal lumen to prevent stool leakage and retracts to
allow normal passage of stool. The device includes an external regulator
to control the state of expansion. The device does not contain drugs or
hormones.

Pelvalon is exhibiting at PFD Week in booth #516.

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. Pelvalon’s investors
include Norwich Ventures, a specialized venture capital firm focused on
medtech.

Contacts

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