Gynesonics’ Incision-Free Sonata Procedure for the Treatment of Uterine Fibroids Reaches Patient Milestone
REDWOOD CITY, Calif., Oct. 17, 2023 (GLOBE NEWSWIRE) — Gynesonics®, Inc. a women’s healthcare company focused on the development of minimally invasive solutions for symptomatic uterine fibroids, is pleased to announce that its Sonata® Procedure has been used to treat over 1,000 women in the United States and approximately 6,500 women globally. With the recent addition of coverage from United Healthcare in August, Gynesonics is also proud to announce that 19 of the top 20 U.S. commercial payors cover Sonata (representing 275 million total lives overall).
The Sonata® System is a technology platform that 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 corresponding Sonata Procedure 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 Procedure requires no incisions, no tissue is surgically removed, and the uterus is preserved.
Commenting on the milestones, Skip Baldino, President and Chief Executive Officer of Gynesonics said, “Uterine fibroids can cause significant and debilitating symptoms, and the symptoms may worsen over time if the fibroids are left untreated. The significant increase in women and physicians choosing Sonata as their treatment option is a testament to the substantial safety, efficacy and economic benefits that our Sonata technology provides.”
Uterine fibroids are benign growths in or around the uterus. They are common and most women develop them during childbearing age. In the U.S., around 70% of white women and more than 80% of black women will have uterine fibroids before the age of 50. Problematic fibroids can range in size from a raisin to a grapefruit, and symptoms may worsen over time if fibroids are left untreated. 20% to 50% of women with fibroids are symptomatic and each year in the U.S., more than 2 million women undergo treatment for uterine fibroids. Women with symptomatic fibroids may present one or more of the following:
Abnormal uterine bleeding/menorrhagia
Increased abdominal girth
Dyspareunia (painful intercourse)
About the Sonata System
The Sonata System is intended for diagnostic intrauterine imaging and transcervical treatment of symptomatic uterine fibroids, including those associated with heavy menstrual bleeding. Common Side Effects include bleeding, spotting, cramping, post-ablation inflammatory symptoms, and/or discharge. There are potential risks with this treatment such as skin burn and infection. Women who are pregnant, have a pelvic infection, are known to have gynecologic cancer, or have intratubal implants for sterilization should not have this procedure.
The Sonata System is CE marked and is approved for sale in the European Union, the United Kingdom, Switzerland, and the United States. For more information on Sonata, please visit us at www.sonatasystem.com.
About Gynesonics As pioneers in women’s health, Gynesonics is committed to developing and delivering minimally invasive, incision-free, uterus-preserving, transcervical technologies for diagnostic and therapeutic applications. Our flagship product, the Sonata System, is the first FDA cleared medical device 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.