Gynesonics Inc. Received CE Mark Approval for its Next Generation VizAblate® System Enabling Use Throughout the European Union

REDWOOD CITY, Calif.–(BUSINESS WIRE)–Gynesonics, Inc., a women’s healthcare company that has developed a minimally invasive device for the treatment of symptomatic uterine fibroids, announced today that it has received CE Mark approval for its next generation VizAblate® System. The CE Mark enables Gynesonics to market its proprietary VizAblate System throughout the European Union.

“Gynesonics offers a unique and differentiated approach to treating symptomatic uterine fibroids that combines ease-of-use with excellent clinical results,” said President and CEO Christopher M. Owens. “This regulatory clearance is an important milestone for the organization. We look forward to sharing additional clinical data while moving forward with our commercialization strategy to provide millions of women with a novel and less-invasive solution to treat their symptomatic uterine fibroids.”

Physicians familiar with the previous VizAblate device are also looking forward to the deployment of the next-generation design. Dr. Hans Brölmann, gynecologist at the Vrije Universiteit Medisch Centrum in Amsterdam, The Netherlands, says, “The latest iteration of the VizAblate device allows accurate placement of fibroid ablations with a single, unique handheld instrument. The imaging is clear and the ease of use will provide gynecologists with an exciting new fibroid treatment that delivers short procedure times.”

About VizAblate:

VizAblate uses radiofrequency energy to ablate fibroids under intrauterine sonography guidance. The VizAblate device and software allows users to visually target specific fibroids and optimize ablations within them. VizAblate’s unique transcervical access is simple, is associated with short procedure times, requires minimal in-procedure assistance, and is incision-free. Treatment with the VizAblate System is confined to the uterus; the device does not violate the uterine serosa or peritoneal cavity and is a distinct alternative to power morcellation procedures.

The Next Generation VizAblate System Features:

• The only device that integrates ultrasound image guidance and radiofrequency ablation into a single handheld device
• Incision-free, no implants or particles left behind, no use of ionizing radiation or contrast media
• No need for laparoscopy or hysteroscopy (negating the need for abdominal insufflation or substantial fluid distention of the uterus)
• An industry-first and exclusive graphically-based ablation sizing guide and safety margin indicator, providing real-time visual guidance for planning a fibroid ablation
• Proprietary intrauterine ultrasound probe that provides an unparalleled high-resolution, clear image
• A straightforward workflow that results from the integration of all components with an optimized graphical user interface allowing gynecologists to focus on imaging and targeting, without having to measure or enter settings into a generator – no need for the physician to coordinate more than one device

About Gynesonics:

Gynesonics is a women’s healthcare company focused on minimally invasive solutions for symptomatic uterine fibroids. Gynesonics has developed the VizAblate® System for the transcervical treatment of symptomatic uterine fibroids under intrauterine ultrasound guidance. VizAblate has received CE Mark approval for commercial sale in the European Union. VizAblate is not available for sale in the United States. Gynesonics is a privately held company with headquarters in Redwood City, CA.