Gynesonics initiates VizAblate FAST-EU study for uterine fibroid treatment

Gynesonics, Inc., a women's 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.

“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.”

Centers in the Netherlands, the United Kingdom, and Mexico are participating in the study. Professor Hans Brölmann 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, Máxima Medisch Centrum, Eindhoven/Veldhoven, The Netherlands
• Jose Gerardo Garza-Leal, MD, Professor of Obstetrics and Gynecology, Hospital Universitario "Dr. José Eleuterio González" de Universidad Autonoma de Nuevo León, Monterrey, Mexico
• Janesh Gupta MSc, MD, FRCOG, Professor of Obstetrics and Gynaecology, Birmingham Women's Hospital, Birmingham, UK
• Siân 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 Kingdom's 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 women's 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.