Gynesonics Names James Sparks Vice President of Manufacturing

Respected Leader in Medical Device Manufacturing and Engineering

REDWOOD CITY, Calif.–(BUSINESS WIRE)–Gynesonics, a women’s healthcare company focused on the development and
commercialization of breakthrough products and procedures designed to
transform the treatment of symptomatic uterine fibroids, today announced
that medical device executive James Sparks has been named Vice President
of Manufacturing, effective immediately. Mr. Sparks reports directly to
Chief Operating Officer Jordan Bajor.

Mr. Sparks has more than 26 years of experience in the medical device
industry focused on manufacturing and engineering management. Most
recently, from September 2013 to March 2016, he served as Vice President
of Manufacturing and Engineering at Tridien Medical, a manufacturer of
patient positioning devices and support surfaces to assist caregivers in
preventing and treating pressure ulcers. Mr. Sparks’ responsibilities at
Tridien included managing three domestic manufacturing facilities with
more than 300 employees. Prior to that he performed senior
manufacturing/operations leadership roles with Class III implantable
heart valves/transcatheter delivery systems (Medtronic), Class II
therapeutic laser systems (BIOLASE), Class II/III cardiology and
electrophysiology products (J&J/Biosense Webster). He began his career
with Baxter/Edwards Life Sciences as a manufacturing/packaging engineer.

“James’ impressive track record in leading the growth and development of
medical device manufacturing organizations includes both domestic and
off shore operations,” Jordan Bajor explained. “He has demonstrated
expertise in cellular manufacturing, demand flow and lean operations
techniques. Most importantly, he has applied his skills and experience
in successfully supporting rapid commercial growth with the most
rigorously regulated medical devices.”

Chris Owens, Gynesonics President and CEO, added: “James has tremendous
experience in scaling high growth medical devices, reducing costs,
simplifying process while maintaining the highest level of quality.
These skills have been developed and utilized at companies which are
benchmarked for manufacturing excellence in medical technology. His
expertise at ramping manufacturing organizations is an essential
addition to our management team. James will continue to develop our
manufacturing systems and processes while implementing our global
manufacturing plan to support the global launch and rapid uptake of our
Sonata® System. We are pleased to have James join the team.”

Mr. Sparks has a B.S. in Engineering Technology from West Coast
University and a MBA in Technology Management from the University of
Phoenix. He completed six sigma training and implementation with Johnson
& Johnson and served for four years in the U.S. Air Force as a

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.

About Gynesonics

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.


Chris Owens
President and CEO