Market Overview

Gynesonics Receives FDA Clearance to Market Sonata® System


Advanced technology offers potential to become a new standard of care
for fibroid treatment

Gynesonics, a women's healthcare company focused on the development of
minimally invasive solutions for symptomatic uterine fibroids, today
announced that it has received 510(k) clearance from the U.S. Food and
Drug Administration (FDA) to market its Sonata®
Sonography-Guided Transcervical Fibroid Ablation (Sonata) System.

The Sonata System combines a breakthrough integrated technology which is
the first and only intrauterine ultrasound system with a proprietary
radiofrequency ablation device, providing a transcervical,
incision-free, uterus-preserving treatment for uterine fibroids.

With an estimated volume of more than 1 million annual global fibroid
procedures, Gynesonics projects a $3 billion-4 billion global market
opportunity for its Sonata System for the treatment of uterine fibroids,
including a market opportunity of more than $1 billion in the U.S. alone.

"We are excited to announce FDA clearance of our Sonata System. This is
an essential milestone for Gynesonics in our mission to bring this
transformational technology for the treatment of uterine fibroids to
women," said President and CEO Christopher Owens. "The patient outcomes
achieved with Sonata demonstrate its potential to become a new standard
of care in fibroid treatment, providing important patient benefits as
compared to invasive surgery. Clinical trial outcomes show that Sonata
provides a significant and durable improvement in symptoms with more
than half the women returning to normal activities within 24 hours."

In a published survey of 968 women affected by fibroids (American
Journal of Obstetrics and Gynecology
, 2013), the key findings

  • 79% of women want to avoid invasive surgery;
  • Affected women wait an average of 3.6 years before being treated;
  • Most women, regardless of desire for future fertility, want to
    preserve their uterus.

"The published survey results show that women are looking for new
options to address this widespread condition, they want to preserve
their uterus and they wish to avoid invasive surgery, including
hysterectomy," Owens added. "Sonata is the only system that can treat
the vast majority of all fibroids with a transcervical, incision-free,
uterus-preserving approach. Current transcervical options are limited to
treatment of a small portion of the total fibroid market by comparison."

According to medical literature, about 70-80 percent of women in the
U.S. will develop uterine fibroids by age 50, with a significant
proportion of women having symptoms, many of which can be severe and
debilitating. In addition, according to the New England Journal of
, approximately 200,000 hysterectomies are performed in the
United States each year because of symptomatic fibroids.

Owens added that the company exceeded the FDA-specified 12-month primary
endpoint performance requirements for the Sonata System in the SONATA
pivotal IDE clinical trial used to support the FDA regulatory 510(k)
filing. The co-primary endpoints included a significant reduction in
bleeding and a high rate of freedom from surgical reintervention due to
heavy menstrual bleeding (HMB). The safety outcomes were also favorable,
including zero device-related adverse events reported in the 147-patient

About Sonata System

The Sonata System, the next generation of Gynesonics' 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 Guide™, enables the
operator to target fibroids and optimize ablations within them. Sonata
system'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.

About Gynesonics

Gynesonics is a women's healthcare company focused on advancing women's
health, by developing minimally invasive, transcervical,
uterus-preserving, incision-free technologies for diagnostic and
therapeutic applications. Gynesonics has developed the Sonata System for
diagnostic intrauterine imaging and transcervical treatment of
symptomatic uterine fibroids. The Sonata System is CE marked. Sonata is
approved for sale in the European Union and the United States.
Gynesonics is a privately held company with headquarters in Redwood
City, CA. For more information, go to

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