Gynesonics Announces Anthem, the Second Largest Healthcare Payer in the U.S., Issues Medical Necessity Coverage for the Treatment of Symptomatic Uterine Fibroids with the Sonata Procedure
Redwood City, CA, September 14, 2021 – Gynesonics®, a women’s healthcare company focused on the development of minimally invasive solutions for symptomatic uterine fibroids, announced Anthem, Inc., the largest managed health care company in the Blue Cross Blue Shield Association, has provided positive payer coverage for the Sonata® Treatment. Anthem’s decision creates access for this minimally invasive procedure for women across the country, having the largest impact in California, New York, Georgia, Ohio, Virginia and Indiana. The Sonata technology platform integrates the first and only commercial intrauterine ultrasound system with a proprietary advanced radiofrequency ablation device, providing an incision-free, uterus-preserving, transcervical treatment for symptomatic uterine fibroids. The Sonata Treatment is an alternative to hysterectomy and myomectomy, and can treat a wide range of fibroid types, sizes and locations. Fibroids are treated from inside the uterus, so the Sonata Treatment requires no incisions, no tissue is surgically removed, and the uterus is preserved.
Anthem is one of the country’s largest healthcare insurance plans and this policy validates the need for less invasive treatment options for women with systematic fibroids. Currently in the U.S. women will wait 3-5 years for treatment trying to avoid invasive surgery. As well, black women have the highest incidence of fibroid diagnoses, yet studies show they are least likely to be offered less invasive treatment options. 1,2
“We hope this coverage policy helps ensure access to all women seeking less invasive treatments,” said Kelly Petrucci, Global VP of Strategy and Market Access for Gynesonics. “At Gynesonics, we are committed to delivering solutions to patients, physicians and health insurers that combine safety, efficacy and economic benefits, positively impacting the entire healthcare system.”
In the SONATA clinical trial, 95 percent of patients experienced a reduction in menstrual bleeding by 12 months. Additionally, 50 percent of women return to normal activities the next day. The overall impact of treatment with Sonata was significant for these women, with 97 percent of women at 12 months indicating they would recommend the procedure. Women were followed in the study long-term which demonstrated durable symptom relief for three years.2
“The positive coverage decision from Anthem supports the rapid acceleration and acceptance of the Sonata treatment. This follows the recent inclusion of Sonata by ACOG in the fibroid treatment Practice Bulletin as well as the 2021 European Consensus publication recommending a new fibroid treatment algorithm with the Sonata technology at the forefront,” said Chris Owens, President and CEO of Gynesonics. “These important policies and clinical recommendations further advance our commitment to ensuring patient and physician access, engagement, and education for the Sonata technology.”
For more information about the Sonata System, please visit https://gynesonics.com/us/sonata-system/.
About Sonata System
The Sonata System uses radiofrequency energy to ablate fibroids under real time sonography guidance from within the uterine cavity, utilizing the first and only intrauterine ultrasound transducer. The system includes a proprietary graphical user interface (SMART Guide), enabling the operator to target fibroids and optimize treatment. The Sonata System provides incision-free transcervical access for a uterus-preserving fibroid treatment. This intrauterine approach is designed to avoid the peritoneal cavity. Most side effects are typically minor and temporary. The Sonata System is CE marked and is approved for sale in the European Union, the United Kingdom, and the United States.
Gynesonics is a women’s healthcare company focused on advancing women’s health, by developing minimally invasive, incision-free, uterus-preserving, transcervical technologies for diagnostic and therapeutic applications. Gynesonics has developed the Sonata System for diagnostic intrauterine imaging and transcervical treatment of symptomatic uterine fibroids. Gynesonics headquarters is in Redwood City, CA. For more information, go to www.gynesonics.com.