FDA Clears Gynesonics to Market Incision Free Fibroid Ablation System

• There are an esitmated 1 million annual global fibroid procedures
• The company estimates the annual US market to be more than $1 billion

Gynesonics, a women’s healthcare company focused on the development of minimally invasive solutions for symptomatic uterine fibroids announced on 8/22/18 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.

In a published survey of 968 women affected by fibroids (American Journal of Obstetrics and Gynecology, 2013), the key findings include:
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 Medicine, approximately 200,000 hysterectomies are performed in the United States each year because of symptomatic fibroids.

The Sonata System 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.