REDWOOD CITY, Calif., Aug. 01, 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 is now covered by UnitedHealthcare, effective August 1, 2023. UnitedHealthcare offers the full spectrum of health benefit programs for individuals, employers, and Medicare and Medicaid beneficiaries, and contracts directly with more than 1.5 million physicians and care professionals, and 7,000 hospitals and other care facilities nationwide.
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 coverage, Skip Baldino, President and Chief Executive Officer of Gynesonics said, “This positive coverage decision by UnitedHealthcare underscores the significant safety, efficacy and economic benefits that our Sonata technology provides to patients, providers and payers. With all top five payers covering Sonata, we are excited to provide access to millions of women suffering from symptomatic fibroids and seeking a less invasive treatment option.”
Jenny Zimmer, Manager of Reimbursement and Payor Relations for Gynesonics added, “We are extremely pleased to see UnitedHealthcare recognize the need for less invasive procedures like Sonata to treat uterine fibroids. Their decision to cover Sonata marks a significant victory for women across the country!”
Leslie Hansen Lindner, M.D., Atrium Health Women’s Care Charlotte OB/GYN said, “I am very excited to be able to provide comprehensive fibroid care for women, and to now be able to offer women with UnitedHealthcare multiple choices for their fibroid treatments. The long-awaited approval for Sonata transcervical fibroid ablation will provide options for each patient to choose the procedure that best works for her needs, her symptoms and her fibroids.”
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
- Abdominopelvic pain/pressure
- Increased abdominal girth
- Urinary frequency
- Constipation
- Subfertility
- Pregnancy complications
- 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.
Company Contact:
Tara Murphy, Director, Global Marketing & Advocacy, Gynesonics, tmurphy@gynesonics.com, (215) 620-3004
Media Contact:
David Gutierrez, Dresner Corporate Services, dgutierrez@dresnerco.com, (312) 780-7204
