Volcano's VH(R) IVUS Technology Used in Imaging Study of GlaxoSmithKline's Novel...

Volcano's VH(R) IVUS Technology Used in Imaging Study of GlaxoSmithKline's
Novel Investigational Compound, Darapladib
IBIS-2 (Integrated Biomarker and Imaging Study) Results Demonstrate Benefits
of VH(R) IVUS in Drug Development

SAN DIEGO, Calif., Sept. 2 /PRNewswire-FirstCall/ -- Volcano Corporation
(Nasdaq: VOLC) [ESC Booth # A2-D403], a leading manufacturer of intravascular
ultrasound (IVUS) and functional measurement (FM) technology, announced today
the use of its VH(R) IVUS (Virtual Histology IVUS) in GlaxoSmithKline's IBIS-2
trial (Integrated Biomarker and Imaging Study). In the study, Volcano's VH(R)
IVUS technology demonstrated and quantified compositional changes in
atherosclerotic plaque that occurred over time. In IBIS-2, VH(R) IVUS showed
compositional changes in the placebo group that suggest continued progression
of necrotic core despite standard of care therapy. Use of the novel Lp-PLA2
inhibitor, darapladib, plus standard of care therapy prevented this
progression. VH(R) IVUS is a catheter-based technology that creates colorized
tissue maps of plaque composition in real-time.
Despite remarkable advances in diagnosis and therapy, atherosclerotic
cardiovascular disease (CVD) is the number one killer of men and women in the
Western world. Principal manifestations of atherosclerotic cardiovascular
disease are heart disease and stroke. Atherosclerosis is the underlying
mechanism for coronary artery disease, ischemic strokes, and peripheral
vascular disease. Although a number of factors contribute to CVD, elevated
plasma levels of Lp-PLA2 (lipoprotein-associated phospholipase A2) are
associated with an increased risk.
"The results of IBIS-2 indicated that many coronary vessels with mild
angiographic disease have large atherosclerotic plaques, which can be
identified by VH(R) IVUS. The ability to characterize composition of these
lesions can potentially provide a means to examine the natural history of
atherosclerosis. This, combined with studies of novel agents that act
directly on the plaque, can help increase our understanding of the mechanisms
of future clinical events," commented Patrick Serruys, MD, PhD, Professor of
Medicine, the Erasmus University, and Chairman of the Steering Committee for
IBIS-2.
IBIS-2 was a 52 week, 300 participant, international, multicenter,
randomized, double-blind, placebo-controlled, parallel group trial of
darapladib in subjects with angiographically documented coronary heart
disease. The main objectives of the study were to determine the effects of
darapladib on composition and biomechanical properties of atherosclerotic
plaque, as well as circulating inflammatory biomarkers.
"Current treatments for atherosclerosis include preventative lifestyle
modifications and the regulation of physiological and biochemical risk factors
such as blood pressure and lipid profile. VH(R) IVUS measures the effects of
investigational compounds on plaque composition. We believe that IVUS can be
an indispensable assessment tool in the development of a drug candidate that
directly affects coronary plaque stability, as opposed to treating symptoms or
lipid levels alone," said Scott Huennekens, President and CEO, Volcano Corp.
"The ability to identify and characterize composition may lead to great
advances in CVD drug development, diagnosis, and eventually tailored systemic
therapy. The same way a biopsy and other blood and imaging tests can define a
cancer treatment plan, we believe that one day Volcano technology could help
define a personalized patient by patient strategy for systemic and local
therapy that could dramatically improve patient outcomes."
Volcano's VH(R) IVUS technology uses advanced spectral analysis techniques
to allow simplified interpretation of ultrasound images and provide detailed
information on the composition of each patient's atherosclerotic plaques. The
color VH images show four plaque component types: necrotic core, dense
calcium, fibrous and fibro-fatty. VH(R) IVUS images are created using
Volcano's imaging console along with the Eagle Eye(R) Gold IVUS imaging
catheter. Images are displayed live, in the catheterization laboratory for
easy review by the interventional cardiologist and his or her staff while the
patient remains on the table. No changes to standard clinical practice are
required to employ VH(R) IVUS. This novel technology provides automated
measurement tools to simplify image interpretation and employs a
pre-determined color key to display plaque composition at a specific point in
the artery or across a region of interest.
About Volcano Corporation
Volcano Corporation (Nasdaq: VOLC) offers a broad suite of devices
designed to facilitate endovascular procedures, enhance the diagnosis of
vascular and structural heart disease and guide optimal therapies. The
company's intravascular ultrasound (IVUS) product line includes ultrasound
consoles that can be integrated directly into virtually any modern cath lab.
Volcano IVUS offers unique features, including both single-use phased array
and rotational IVUS imaging catheters, and advanced functionality options,
such as VH(R) IVUS tissue characterization and ChromaFlo(R). Volcano also
provides functional measurement (FM) consoles and single-use pressure and flow
guide wires and is developing a line of ultra-high resolution Optical
Coherence Tomography (OCT) and Forward Looking IVUS systems and catheters.
Currently, more than 3,500 Volcano IVUS and FM systems are installed
worldwide, with approximately half of its revenues coming from outside the
United States. For more information, visit the company's website at
http://www.volcanocorp.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning
of the U.S. Private Securities Litigation Reform Act of 1995. Any statements
in this release regarding Volcano's business that are not historical facts may
be considered forward-looking statements, including statements regarding the
ability of VH(R) IVUS to measure the effects of investigational compounds, the
ability to identify and characterize composition and to define patient
strategy to improve patient outcomes. Forward-looking statements involve
risks and uncertainties and are based on management's current expectations.
Actual results could differ materially from these forward-looking statements
as a result of certain factors, including the risks and uncertainties related
to the results of clinical studies and other factors discussed in Volcano's
filings with the Securities and Exchange Commission. Undue reliance should
not be placed on forward-looking statements, which speak only as of the time
they are made. Volcano undertakes no obligation to update any forward-looking
statements to reflect new information, events or circumstances, changed
assumptions or otherwise. Actual results or experience could differ materially
from the forward-looking statements.
SOURCE Volcano Corporation

Joe Burnett, Associate VP of Marketing of Volcano Corporation,
+1-916-337-8352, jburnett@volcanocorp.com; or Shalon Roth of Ricochet Public
Relations, +1-212-679-3300, ext. 127, sroth@ricochetpr.com, for Volcano
Corporation