Advanced Women’s Health Institute Treats First Patients in National Study of New Incision-Free, Transcervical Treatment of Uterine Fibroids

Center Is only Clinical Research Center in Colorado Chosen to
Participate in Clinical Study; Actively Seeking Additional Patients to
Take Part

DENVER–(BUSINESS WIRE)–Advanced Women’s Health Institute, a medical group that advocates for
minimally invasive treatment solutions for women, announced today that
it has treated its first two patients in the SONATA study, an
investigational study of new technology designed to reduce heavy
menstrual bleeding caused by uterine fibroids. Advanced Women’s Health
Institute, the only clinical research center in Colorado chosen to
participate in the study, is actively seeking other potential patients
suffering from uterine fibroids to take part in the clinical trial.
Information on the study can be found at www.sonatatrial.com.

One out of three women will experience uterine fibroids during their
reproductive years. Each year, more than 340,000 women in the U.S.
undergo treatment for uterine fibroids at a cost of more than $6
billion. Symptomatic fibroids can cause painful periods and heavy
menstrual bleeding which impact the quality of life for many women.

Treatment options for uterine fibroids vary from hysterectomy
(surgically removing the uterus) to hormone therapy. “New uterine
preserving technologies, such as the Sonata System developed by
Gynesonics, are emerging with the intent to treat fibroids in less
invasive, less painful ways,” noted Michael L. Moore, M.D., an OB/GYN
and principal of the Advanced Women’s Health Institute.

“The Sonata procedure is an important new incision-free procedure for
patients with uterine fibroids,” Dr. Moore said. “It does not require
general anesthesia and is much less invasive than other current options
for women. Our patients returned to normal activity within two days.”

Premenopausal women between 25-50 years of age with fibroids, who suffer
from heavy menstrual bleeding and do not wish to become pregnant, may be
eligible to participate in the study. The study will enroll about 150
patients around the U.S. and the data will be evaluated by the Food and
Drug Administration to determine the availability of the Sonata
procedure in the United States. The Sonata system is CE Marked and
available commercially in Europe.

For more information about this clinical trial, contact the Study
Coordinator, Donnis Moore at 303-321-2255 or donnis@advancedgyn.com.
Additional information is also available at www.sonatatrial.com.

Contacts

Advanced Women’s Health Institute
Donnis Moore, 303-321-2255
donnis@advancedgyn.com