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Sonata demonstrates significant advantages in reducing procedure time, length of stay and procedure related costs compared to myomectomy.

Redwood City, CA, June 30, 2020 – Gynesonics^®, a women’s healthcare company focused on the development of minimally invasive solutions for symptomatic uterine fibroids, announced the peer reviewed publication of CHOICES, a comparative, case-matched healthcare economic study.  The study compared the short-term resource utilization, facility costs, and perioperative patient outcomes for transcervical fibroid ablation (TFA) using the Sonata^® system compared to myomectomy.  CHOICES demonstrated that TFA using the Sonata system has a significantly shorter operating room time and length of stay than myomectomy for the treatment of symptomatic uterine fibroids.  All procedure, anesthesia, laboratory, pathology, and pharmacy costs were significantly higher for myomectomy as compared to TFA with Sonata.  TFA was also associated with significantly lower facility procedure-related costs compared to myomectomy, including inpatient, abdominal, or laparoscopic myomectomy.

“The significant clinical advantages demonstrated by Sonata in the CHOICES comparator study compared to myomectomy, along with the long-term symptom relief and high patient satisfaction as reported in the FAST-EU and SONATA clinical trials, clearly shows that Sonata should be the standard of care when considering options for women with symptomatic fibroids,” said, David Forstein, DO, FACOOG, Dean, Harlem Campus, Touro College of Osteopathic Medicine, New York City.  “The considerable, robust and consistent data reported in multiple peer-reviewed publications to date, is compelling and supports Sonata as being a key component in the algorithm for treating uterine fibroids.”

“The impressive durable patient outcomes already published on Sonata, out to more than 5 years, has established the clinical importance of our technology,” commented Gynesonics President and CEO, Christopher Owens.  “CHOICES, an essential head-to-head comparator study, now demonstrates the procedural cost and early patient outcome advantages provided by Sonata over myomectomy.  Peer-reviewed published clinical data for Sonata, continues to demonstrate significant advantages for the patient, facility, payers and the physician.”

CHOICES (Brooks E, Singer A, Delvadia D et al. ClinicoEconomics and Outcomes Research. 2020:12 299-306) is a multi-center, case matched comparator 30-day outcomes and facility cost analysis study.  A total of 88 patients at 4 centers were enrolled, equally divided between the two cohorts.  The design controlled for potential biases such as prior procedural experience, internal facility procedures and protocols, facility billing practices and patient demographic differences.  The outcomes included:

• Sonata TFA had a significantly lower mean operating room duration (90 minutes) and length of stay (5.2 hours) than myomectomy (143 minutes and 45.8 hours respectively)
• The average total mean facility costs for myomectomy ($11,425) were 51% higher than for Sonata TFA ($7,563, p=0.002)
• Sonata TFA facility costs were significantly lower than that associated with inpatient, abdominal, or laparoscopic myomectomy (all p<0.001)

Elizabeth Brooks, Ph.D., healthcare economist and lead author on CHOICES said, “This case-matched comparator study identified important cost and operative patient outcome advantages provided by Sonata compared to a surgical standard of care – myomectomy.  These data provide essential insights to payers and facilities in the evaluation of a breakthrough technology in addressing a significant clinical need.”

CHOICES is the third recently published study providing analysis of facility and payer costs for Sonata compared to surgical treatments for fibroids, hysterectomy and myomectomy.  The previous publications are the INSPIRE and COMPARE studies.  This base of healthcare economic evidence consistently demonstrates the cost benefits to both facilities and payers provided by Sonata in relation to hysterectomy and myomectomy.  This is important data that complements the significant base of published clinical outcomes data demonstrating the impressive and durable benefits of the Sonata treatment for patients – out to more than 5 years.

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.

About Gynesonics

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

CONTACT:  David Toub, MD, MBA, FACOG, Medical Director, Gynesonics –