Accomplished Clinical Affairs Executive to Lead Clinical Research
Initiatives and Programs
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.
President and CEO