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July 1st 2015

Gynesonics’ Sonata™ System Winner of 2015 Medical Design Excelle

REDWOOD CITY, Calif.--(BUSINESS WIRE)--Gynesonics, a women’s healthcare company focused on the development of minimally invasive solutions for symptomatic uterine fibroids, today announced that its Sonata System was selected as the Bronze Winner in the Radiological and Electromechanical Devices Category at the 18th Annual Medical Design Excellence Awards competition. The 2015 MDEA winning products were announced at a ceremony held June 9 at the Jacob K. Javits Convention Center in New York. Sean Finson, Project Engineer, represented the Gynesonics team at the award ceremony.

Sonata, the name of the latest generation of the Company’s technology platform, is an acronym for the innovative uterus preserving, incision-free approach to the treatment of a wide range of symptomatic uterine fibroid types. Sonata (Sonography-Guided Transcervical Ablation of Uterine Fibroids) combines and integrates a high resolution, compact ultrasound probe at the tip of a radiofrequency ablation device in a single handheld transcervical delivery system.

The MDEA awards are the medtech industry’s premier design competition committed to searching worldwide for the highest caliber finished medical devices, products, systems, or packaging available on the market. The awards program celebrates the achievements of the medical device manufacturers, their suppliers, and the many people behind the scenes—engineers, scientists, designers, and clinicians—who are responsible for the cutting-edge products that are saving lives, improving patient healthcare, and transforming medtech—one innovation at a time.

“It is exciting to receive this recognition in a very competitive field of applicants and from this diverse group of independent experts,” said Chris Owens, President and CEO of Gynesonics. “It serves as an acknowledgement of all the inspired work completed by the Company over the past several years, in particular the significant platform advancements included in the latest generation Sonata System. The impressive clinical results achieved with our platform technology, as highlighted in the recent publication of our FAST-EU trial, demonstrates the potential of Sonata to change the standard of care for a large proportion of symptomatic uterine fibroids.”

The 2015 MDEA Juror Panel judged products based on design and engineering innovation, function and user-related innovation, patient benefits, business benefits, and overall benefit to the healthcare system. The MDEA jury is comprised of a balance of practicing doctors, nurses, and technicians alongside industrial designers, engineers, manufacturers, and human factors experts.

About Sonata System

The Sonata System, the next generation of the Company’s technology platform (the previous generation referred to as VizAblate), uses radiofrequency energy to ablate fibroids under intrauterine sonography guidance. The Sonata System, including the SMART Targeting Guide, enables the operator to target fibroids and optimize ablations within them. Sonata’s design provides a straightforward, transcervical access for a uterus preserving, incision-free fibroid treatment. This intrauterine approach is designed to avoid the peritoneal cavity. In October 2014, Gynesonics announced FDA approval of the SONATA IDE pivotal trial for their latest generation Sonata System.

About Gynesonics

Gynesonics is a women’s healthcare company focused on minimally invasive solutions for symptomatic uterine fibroids. Gynesonics has developed the Sonata™ System for the transcervical treatment of symptomatic uterine fibroids under intrauterine sonography guidance. The Sonata System is CE Marked and approved for sale in the European Union. Sonata is not available for sale in the United States. Gynesonics is a privately held company with headquarters in Redwood City, CA.

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