REDWOOD CITY, Calif.--(BUSINESS WIRE)--Gynesonics®, a women’s healthcare company focused on the development of minimally invasive solutions for symptomatic uterine fibroids, announced today that Health Care Service Corporation (HCSC) has released a coverage policy for The Sonata® Procedure. The addition of HCSC policy allows another 16 million covered lives access to this minimally invasive procedure. 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 a breakthrough 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.
“I am extremely pleased to see health insurance plans, such as HCSC, recognize the impact uterine fibroids have on a woman’s life and the importance of providing minimally invasive treatment options. As a surgeon, it is my responsibility to determine the best treatment option based on a patient’s symptoms. Sonata should be made available to all women who need it. It is time local and national health plans follow suit with other carriers that have included Sonata in their coverage policies,” said Charles Miller, Director of Minimally Invasive Gynecologic Surgery at Advocate Lutheran General Hospital in Park Ridge, IL; Professor, Obstetrics & Gynecology - Department of Clinical Sciences, Rosalind Franklin University of Medicine and Science, North Chicago, IL; and a past President of the American Association of Gynecological Laparoscopists (AAGL) and International Society of Gynecological Endoscopy (ISGE). “I have seen the evolution of minimally invasive fibroid treatment options. The Sonata procedure is one that I choose for a specific patient population whose life has been impacted by this disease. Sonata is the least invasive approach to fibroids wholly or partially within the myometrium of the uterus. Minimally invasive treatments for uterine fibroids have advanced and provide women a safe and effective alternative to more invasive treatments.”
In the SONATA clinical trial, within three months following their Sonata Treatment, 86 percent of women experienced a reduction in heavy menstrual bleeding and 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 in the study experienced significant durable symptom relief through three years.
“The announcement of this coverage policy from HCSC is an exciting milestone for both patients and providers to expand the options available to women suffering with symptomatic uterine fibroids. Data reports nearly 80 percent of women prefer to avoid invasive surgery for fibroids and prefer a less invasive option,” said Chris Owens, President and CEO of Gynesonics. “The health insurance companies are listening to patients and providers, and then addressing their needs by creating access to a less invasive treatment option with the Sonata System. The addition of coverage policies nationwide reflects the robustness of the clinical evidence supporting the Sonata treatment as a safe, effective, and durable option.”
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. The Sonata System is CE marked and is approved for sale in the European Union 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.