Gynesonics Announces the Start of the FAST-EU Study for

the VizAblate System

REDWOOD CITY, Calif.--(BUSINESS WIRE)--Gynesonics, Inc., a womens healthcare company

focused on minimally invasive solutions for symptomatic uterine fibroids, today announced the start
of, and initial treatments in, the FAST-EU Trial, a multicenter clinical study to demonstrate the
effectiveness of the VizAblate procedure for the treatment of uterine fibroids associated with heavy
menstrual bleeding. The VizAblate System is the only CE marked system that combines ultrasound
image guidance with radiofrequency ablation to treat fibroids transcervically in an outpatient
setting. Symptoms from uterine fibroids have been reported to affect as many as 24 million women
in the European Union.
Centers in the Netherlands, the United Kingdom, and Mexico are participating in the study.
Professor Hans Brlmann MD, PhD, Head - Department of Obstetrics and Gynaecology, Vrije
Universiteit Medisch Centrum in Amsterdam, Netherlands was the first physician to treat a patient
in the FAST-EU study in the European Union. The VizAblate System represents a new and exciting
approach to treating fibroids associated with heavy menstrual bleeding and has the potential to be a
very important tool for the gynecologist. We are excited to be a part of this study and to have started
treatments at our center.
The additional investigators and centers actively recruiting in the study include,
Marlies Bongers MD, PhD, Gynecologist, Mxima Medisch Centrum, Eindhoven/Veldhoven, The
Netherlands Jose Gerardo Garza-Leal, MD, Professor ofObstetrics and Gynecology,Hospital
Universitario "Dr. Jos Eleuterio Gonzlez" de Universidad Autonoma de Nuevo Len, Monterrey,
Mexico Janesh Gupta MSc, MD, FRCOG,Professor of Obstetrics and Gynaecology,Birmingham
Women's Hospital, Birmingham, UK Sin E Jones MD, FRCOG,Consultant Obstetrician and
Gynaecologist,Department of Obstetrics and Gynaecology,Bradford Teaching Hospitals NHS
Foundation Trust, Bradford, UK Sebastiaan Veersema MD,Gynaecologist,Department of Obstetrics
and Gynaecology,St. Antonius Ziekenhuis,Nieuwegein, The Netherlands.
Gynesonics is continuing to include additional centers.

The FAST-EU trial has been accepted into the United Kingdoms National Institute of Health
Research Clinical Research Network (NIHR CRN) Portfolio database. Acceptance into the Portfolio is
available only for studies perceived as being of high quality and of definite benefit to patients within
the National Health Services. The acceptance of the FAST-EU study into the CRN Portfolio is a
testament to the quality of the study design and the potential of the VizAblate System to positively
impact womens health. We have an outstanding group of clinical investigators and look forward to
completing the study and publishing the results, said Darrin Uecker, President and CEO of
Gynesonics.
The most frequent surgical treatment for symptomatic uterine fibroids is hysterectomy, with
approximately 250,000 hysterectomies being performed in the United States each year for fibroids.
The VizAblate System offers an alternative procedure designed to treat fibroids individually, sparing
the uterus.
The VizAblate System is currently available for investigational use only in the United States.
Gynesonics, Inc. is a privately-held company with venture capital investors Abingworth, Advanced
Technology Ventures, and Interwest Partners. The company has offices in Redwood City, CA.