REDWOOD CITY, Calif.--(BUSINESS WIRE)--Gynesonics, a women’s healthcare company focused on the development of minimally invasive solutions for symptomatic uterine fibroids, today announced that veteran clinical affairs executive Taraneh G. Farazi, Ph.D., has been named Vice President, Clinical Affairs. Dr. Farazi reports directly to President and CEO Christopher M. Owens.
Dr. Farazi has spent her career working in clinical affairs and research in the medical device industry with a proven record for bringing structure and resolution to complex and large scale clinical trials and technology development programs. She has worked on all stages of the clinical trial process, including designing and conducting pre-clinical and clinical feasibility studies, interacting extensively with the FDA to ensure regulatory compliance, and leading and managing global teams. She has developed strong ties with leading physicians in executing all aspects of clinical research and trials, including physician panels, steering committees, clinical events committees, data safety monitoring boards and medical advisory boards.
For the past 15 years she has worked for the St. Jude Medical Clinical Affairs and Research Organizations and, from March 2012 to January 2016, was Program Director, Clinical Affairs. In that role at St. Jude Medical, Dr. Farazi was responsible for the global clinical affairs activities within the cardiac resynchronization (CRT) affairs franchise. She managed the clinical trials for CRT programs worldwide, from concept to post market launch and developed and submitted clinical reports to various regulatory agencies.
“Taraneh brings to our team significant clinical expertise, scientific rigor and strategic awareness that are critical elements in supporting our long term vision as a global leader in women’s healthcare,” Owens said. “She will provide essential depth to our management team as we continue to scale the organization and move aggressively forward with a series of global clinical research initiatives in support of the US approval and global market access objectives for the Sonata System, our enhanced next generation technology platform for the incision-free treatment of uterine fibroids.
“She has worked closely with the FDA and has developed, managed and communicated clinical strategies from the early planning stages all the way through to product approvals with an impressive track record of success,” Owens added. “We look forward to Taraneh spearheading our FDA SONATA IDE trial going forward as well as our other clinical and health economics and outcomes research trials and initiatives while also supporting other R&D and Strategic programs within the company.”
Dr. Farazi holds 93 issued patents and has 62 pending patent applications with the USPTO. In collaborating with physicians worldwide, Dr. Farazi’s publications include several dozen journal articles and conference abstracts in medical device technology.
Dr. Farazi graduated magna cum laude from the California Polytechnic State University (Cal Poly), San Luis Obispo, with a Bachelor of Science degree in computer engineering. In addition, she also earned a master’s degree in electronic engineering from Cal Poly, and a master’s degree and Ph.D. in biomedical engineering from the University of Southern California. Dr. Farazi currently serves on the Computer Engineering Industrial Advisory Board at Cal Poly.
About Sonata System
The Sonata™ System, the next generation of Gynesonics’ technology platform (the previous generation referred to as VizAblate), uses radiofrequency energy to ablate fibroids under intrauterine sonography guidance. The Sonata™ System, including the SMART Targeting Guide, enables the operator to target fibroids and optimize ablations within them. 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. In October 2014, Gynesonics announced FDA approval of the SONATA IDE pivotal trial for their latest generation Sonata™ System.
Gynesonics is a women’s healthcare company focused on minimally invasive solutions for symptomatic uterine fibroids. Gynesonics has developed the Sonata™ System for the transcervical treatment of symptomatic uterine fibroids under intrauterine sonography guidance. The Sonata™ System is CE Marked and approved for sale in the European Union. Sonata™ System is not available for sale in the United States. Gynesonics is a privately held company with headquarters in Redwood City, CA.