A total of 147 patients were enrolled at 22 centers in the U.S. and Mexico. The pivotal trials primary endpoints include the reduction of bleeding and incidence of surgical reintervention, both at 12 months after completion of the procedure. Gynesonicspioneered the sonography-guided, uterus preserving, incision-free, transcervical treatment for symptomatic fibroids. The Sonata procedure involves the transcervical delivery of a single integrated handpiece combining intrauterine sonography guidance with radiofrequency ablation. Gynesonics is the only company in the world with an intrauterine ultrasound imaging and guidance technology platform. We are pleased to have completed the patient enrollment in the SONATA pivotal trial ahead of schedule, said Christopher M. Owens, President and CEO of Gynesonics. There is a significant unmet need for an incision free, uterus-preserving option for the treatment of symptomatic uterine fibroids. We are optimistic and eager to fulfill the requirements of the trial with the goal of demonstrating the value of the Sonata system as a new option for women worldwide. We are already completing the required patient follow-up to support FDA clearance of the Sonata System. Gynesonics expects to complete the required follow up and submit the results to FDA in a 510(k) submission during the fourth quarter of 2017.
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