U.S. Food and Drug Administration Clears Way for Multi-Center Clinical Trial of IDEV Technologies’ SUPERA Peripheral Stent

HOUSTON - Novel Stent Platform Designed for Radial Strength, Flexibility

IDEV Technologies Incorporated, (IDEV) an emerging leader in the
development and marketing of minimally invasive technologies, announced today
that the U.S. Food and Drug Administration (FDA) has approved an
investigational device exemption (IDE) for a multi-center clinical trial of
its SUPERA stent, a novel stent platform designed for the treatment of
peripheral artery disease (PAD) in the superficial femoral artery (SFA). PAD
affects more than 8 million people in the U.S. alone and, by the age of 65,
12-20 percent of the population will develop PAD, according to the American
Heart Association.

The SUPERB trial (Comparison of the SUPERA PERipheral System to a
Performance Goal Derived from Balloon Angioplasty Clinical Trials in the
Superficial Femoral Artery), a prospective, single-arm trial of 258 subjects
at up to 40 U.S. sites, will be led by national co-principal investigators
Kenneth Rosenfield, M.D., of Massachusetts General Hospital, Boston, MA and
Lawrence Garcia, M.D., of Caritas St. Elizabeth’s Medical Center, Boston, MA.

“The approval of this IDE marks a significant step forward toward
understanding the potential benefits of the unique properties of the SUPERA
stent,” Dr. Rosenfeld said. “Members of the physician community have already
shown a high level of interest in this novel stent platform and IDEV’s
commitment to generating prospective clinical data will help us demonstrate
the promise of this device.”

The objective of the trial is to demonstrate the safety and effectiveness
of the SUPERA Interwoven Self-Expanding Nitinol Stent in treating subjects
with obstructive SFA disease. SUPERA has demonstrated superior properties in
engineering tests compared to nitinol laser cut slotted tube stents resulting
in greater than four times the radial strength and 360 percent stronger crush
resistance. The unprecedented increase in radial strength is due to the
product’s novel interwoven design, which adds strength without compromising
flexibility. SUPERA also withstood more than 10,000,000 cycles of repeated
bending - 120 degree flexion and compression loading fatigue testing, without
a fracture.

“We believe SUPERA may prove to be a more durable solution and ultimately
the gold standard for the treatment of PAD, a serious condition for millions
of Americans and others around the world,” said Tom Tully, Chairman and CEO
of IDEV Technologies. “We are excited to begin enrolling subjects into the
SUPERB trial and look forward to compiling data that will demonstrate the
effectiveness of its unique design.”

About IDEV Technologies, Incorporated

IDEV Technologies, Incorporated (IDEV) is an innovator and developer of
next generation medical devices for use in the interventional radiology,
vascular surgery and cardiology device marketplace. IDEV is based in Houston,
Texas.

Contact: Thomas M. Tully, Chairman and CEO
Christopher M. Owens, President and COO
John Dame, Director of Finance
IDEV Technologies Inc.
+1-281-333-1998

Source: IDEV Technologies, Incorporated

Thomas M. Tully, Chairman and CEO, or Christopher M. Owens, President and COO, or John Dame, Director of Finance, all of IDEV Technologies Inc., +1-281-333-1998