Gynesonics Announces Publication of OPEN Clinical Trial Results, Demonstrating No Intrauterine Adhesion Formation Following Treatment with the Sonata System
Clinical Study Demonstrates No Adhesion Formation at Second-Look Hysteroscopy Performed Six Weeks After Transcervical Fibroid Ablation with the Sonata System
Redwood City, Calif. – August 20, 2020 – Gynesonics, a women’s healthcare company focused on the development of minimally invasive solutions for symptomatic uterine fibroids, announced the publication of the OPEN clinical trial results, demonstrating a lack of intrauterine adhesion formation after Transcervical Fibroid Ablation (TFA) with the Sonata® System. Adhesions are often seen with other treatment modalities. Studies involving apposing fibroids have reported a significant (up to 78 percent) risk of adhesiogenesis after hysteroscopic myomectomy. The OPEN trial included women with apposing fibroids, all of whom were free from intrauterine adhesions after TFA. The Sonata technology platform 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.
“Intrauterine adhesions can prevent access to the endometrial cavity for various transcervical procedures, including evaluation of the endometrial lining for premalignant and malignant conditions. Many physicians are concerned about the impact of adhesions on uterine health, and the OPEN trial addresses the potential effect of Sonata on the integrity of the uterine cavity, with no incidence of adhesions after treatment with Sonata,” said Marlies Bongers, M.D., Ph.D., Professor at the Grow-School for Oncology and Developmental Biology, Maastricht University and a gynecologist at Máxima Medisch Centrum in Veldhoven, the Netherlands. “Traditional hysteroscopic treatments such as myomectomy can disrupt the endometrium and the underlying myometrium. There can be complications associated with that damage, such as intrauterine adhesions, especially with multiple fibroids treated near one another, as in the case with apposing fibroids. Sonata is a targeted, focal treatment and the results of the OPEN clinical trial demonstrated no effect upon the endometrial cavity after treating fibroids, including those with the highest risk of forming adhesions.”
The OPEN trial was a prospective trial conducted at six centers and enrolled 37 women who had already chosen TFA with the Sonata System for treatment of their fibroid symptoms. The women were required to have at least one fibroid that indented their uterine cavities, as treatment of these fibroids are most likely to have an impact on the endometrial cavity. The presence or absence of intrauterine adhesions were assessed at baseline prior to treatment via diagnostic hysteroscopy and again at six weeks post-ablation treatment (second-look hysteroscopy). These hysteroscopic findings were captured on videos that were evaluated and scored by a committee of three independent physician readers. A third of the treated fibroids were larger than 4 centimeters and a total of 50 fibroids were treated, all within a single treatment session. Of the 37 women enrolled in the study, 34 had evaluable paired baseline and second-look hysteroscopy videos, and none of these revealed any formation of intrauterine adhesions after treatment with Sonata, including six women with apposing fibroids that typically have a significant risk of forming adhesions after operative hysteroscopic treatment.
“The Sonata TFA treatment has unique advantages compared to all other fibroid treatment options available, and this study demonstrates yet another reason for the rapidly growing patient and provider interest in this breakthrough procedure,” said Gynesonics President and CEO, Christopher Owens. “This trial contributes to our clinical evidence strategy of providing the gynecology community with essential outcomes data.”
“The lack of intrauterine adhesions is of particular interest to women who desire a fibroid treatment that does not affect the integrity of their endometrial cavities, unlike resective treatments for fibroids that can result in significant scarring,” said David Toub, M.D., MBA, gynecologist and Medical Director of Gynesonics. “An ability to perform additional procedures without interference is critical to a physician’s treatment strategy. The clinical results of the OPEN trial provide valuable insights for physicians. The transcervical, incision-free nature of the procedure, combined with the precise ability to target individual or multiple fibroids, rather than the entire uterus, results in a procedure with fast recovery time, significant clinical reduction in symptoms and high patient satisfaction with no evidence of adhesion formation post-treatment.”
About Sonata System
The Sonata System uses radiofrequency energy to ablate fibroids under real time intrauterine sonography guidance. The Sonata System, including the SMART Guide, enables the operator to target fibroids and optimize ablations within them. The Sonata system’s design provides a straightforward, transcervical access for a uterus-preserving, incision-free 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.
Rich Lanigan, VP,Global Commercialization, Gynesonics,
Joanne Tedesco, Dresner Corporate Services,