AMA Establishes Code for Reimbursement of the Innovative Procedure for Uterine Fibroids
Redwood City, CA – August 4, 2015 – Gynesonics, a women’s healthcare company focused on
the development of minimally invasive solutions for symptomatic uterine fibroids, today
announced that the American Medical Association (AMA) Current Procedure Terminology
(CPT) Editorial Panel has established a new AMA CPT® code specifically for Transcervical
Uterine Fibroid Ablation with Ultrasound Guidance. Gynesonics applied for the new code,
which was presented to the Editorial Panel in February.
CPT codes are used by medical practitioners including physicians, hospitals, and other healthcare
providers, to report healthcare services to insurers for the purpose of reimbursement. This
standardized nationwide system of identification provides a uniform language for reporting
The code has the following descriptor: Transcervical uterine fibroid(s) ablation with ultrasound
guidance, radiofrequency. The announcement was posted and made available on the AMA
website. The final code number will be released at a future date and will become effective on
January 1, 2016.
The Sonata™ System from Gynesonics provides a uterus preserving, incision-free treatment
option to women suffering from symptomatic uterine fibroids, including those associated with
heavy menstrual bleeding. Sonata combines and integrates a high resolution, compact ultrasound
probe at the tip of a radio frequency ablation device to provide a single handheld transcervical
treatment delivery system under integrated sonographic guidance.
Gynesonics President and Chief Executive Officer Christopher M. Owens noted that the
Company pursued the Category III designation in conjunction with beginning its pivotal IDE
“This initiative provides us the opportunity to establish a dialogue with the AMA CPT Editorial
Panel, the gynecology societies and their advisors to ensure proper procedure coding, while
completing our FDA SONATA IDE trial,” Owens, said. “Widespread reimbursement coverage
for the Sonata technology is essential to making it available to women with fibroids who can
benefit from its application. In addition to the FDA IDE SONATA Trial, the company will
continue to move forward with additional clinical and health economics and outcomes research
trials. Our intention is to pursue reimbursement coverage and a migration to a CPT Category I
code for the Sonata System upon FDA clearance.”
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 Targeting
2 Guide, enables the gynecologist 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. In October 2014, Gynesonics announced FDA approval of the SONATA IDE pivotal trial
for their latest generation Sonata™ System.
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™
System is not available for sale in the United States. Gynesonics is a privately held company
with headquarters in Redwood City, CA.
Gynesonics President and CEO