Gynesonics® Reaches Milestone with 10,000th Patient Treatment with Sonata System

Cutting-edge incision-free solution advances standard of care for women with uterine fibroids

/EIN News/ -- REDWOOD CITY, Calif., Aug. 20, 2024 (GLOBE NEWSWIRE) -- Gynesonics^®, Inc. a privately-held women’s healthcare medical device company focused on the development of minimally invasive solutions for symptomatic uterine fibroids, is proud to announce that its Sonata^® System has been used to treat over 10,000 women globally. This significant milestone underscores the growing adoption and clinical success of the Sonata Procedure, offering women a safe, effective, and minimally invasive alternative for the management of symptomatic uterine fibroids.

The Sonata^® System integrates the first and only intrauterine ultrasound system with a proprietary advanced radiofrequency ablation device, providing an incision-free, uterus-preserving, transcervical treatment for symptomatic uterine fibroids. The Sonata System utilizes radiofrequency energy to ablate fibroids from within the uterus without the need for any incisions. This innovative procedure is a breakthrough alternative to hysterectomy and myomectomy, performed under ultrasound guidance, ensuring precision and safety. Clinical studies have demonstrated the effectiveness of the Sonata Procedure in significantly reducing fibroid symptoms, with patients reporting high levels of satisfaction and improved quality of life.

“I am grateful for the support of our physician partners across the globe who helped us reach this milestone and are focused on putting patients first and achieving excellence in their effort to provide minimally invasive treatment options for women with uterine fibroids,” said Skip Baldino, President and Chief Executive Officer of Gynesonics. “Uterine fibroids can cause significant and debilitating symptoms, and many women suffer the symptoms rather than have invasive surgery. We are proud to offer a treatment that will preserve their uterus, without incisions and with a rapid recovery. This is the first of many milestones as we continually strive to advance the standard of women’s healthcare.”

Uterine fibroids affect up to 80% of women by the age of 50. Symptomatic uterine fibroids can cause a range of debilitating symptoms, including abnormal uterine bleeding, abdominal pelvic pain or pressure, increased abdominal girth, urinary frequency, constipation, preterm labor, and painful intercourse.

Dr. Taraneh Shirazian, a prominent gynecologist and the Director of the Center for Fibroid Care at NYU Langone Health in New York, shared her insights on the procedure's impact: "The Sonata Procedure has revolutionized the way we treat uterine fibroids. My patients have experienced improved outcomes with faster recovery times and fewer complications compared to traditional surgical methods. It is exciting to have this alternative option to treat this common and debilitating disease."

Gynesonics continues to expand the availability of the Sonata System through partnerships with leading healthcare providers worldwide. The company's commitment to ongoing innovation and clinical excellence ensures that more women will have access to this transformative treatment option.

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.

Sonata is a registered trademark of Gynesonics. Inc.

Company Contact:
Ana Pollock, Senior Marketing Manager, Communications - Gynesonics
apollock@gynesonics.com, (m) 508.726.3820

Media Contact: 
David Gutierrez, Dresner Corporate Services, dgutierrez@dresnerco.com, (312) 780-7204