First patient successfully treated for symptomatic uterine fibroids with Gynesonics' VizAblate System

Gynesonics, Inc., a women's healthcare company focused on the development of minimally invasive solutions for symptomatic uterine fibroids, today announced the first treatment of a patient in Cologne, Germany, using the Company's newly-designed VizAblate® System. VizAblate is the only medical device to integrate ultrasound imaging with radiofrequency ablation in a single handheld device for the treatment of fibroids. The System is minimally invasive and is inserted through the cervix without any need for incisions.

Professor Thomas Römer, M.D., and Ralf Bends, M.D., performed the first procedure with the new VizAblate System at Evangelisches Krankenhaus Köln-Weyertal gGmbH in Cologne, Germany.

"The procedure was straightforward thanks to the unique and improved design of the new VizAblate System," Ralf Bends said. "The intrauterine ultrasound imaging made the navigation and radiofrequency ablation extremely efficient. The entire system can be mastered with a very achievable and short learning curve. This system may produce a paradigm shift in the way patients are treated for symptomatic uterine fibroids."

The new VizAblate System has been designed to improve ease-of-use, increase ultrasound resolution, and streamline the graphical user interface. The incision-less procedure preserves the uterus, does not involve laparoscopy or hysteroscopy, and features the industry's first, exclusive graphically-based ablation sizing guide and safety margin indicator. VizAblate is amenable to an outpatient setting and has short procedure times. VizAblate can ablate larger and deeper fibroids that are not treatable by other transcervical methods.

"Based on our experience, the Gynesonics VizAblate System, which does not require an incision, offers an exciting and less invasive treatment for symptomatic uterine fibroids," said Professor Römer.

Gynesonics President and CEO Christopher M. Owens noted that this is an encouraging first step towards commercialization of the new system, initiating a broader clinical strategy and demonstrating the tremendous value the VizAblate technology may have for millions of women globally.

According to the medical literature, in the United States, about 70-80 percent of women in the US will develop uterine fibroids by age 50. In addition, approximately 200,000 hysterectomies are performed in the United States each year because of symptomatic fibroids, according to the New England Journal of Medicine.

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