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Infraredx Announces Launch of Makoto™ Intravascular Imaging System and Dualpro™ IVUS+NIRS Catheter in Japan

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Nipro Vascular Company Brings the First Dual-Modality Intravascular
Imaging System and Catheter to the World's Largest Imaging Market

Infraredx, Inc., a pioneer in intravascular imaging for mapping coronary
artery disease, today announced the Makoto™ Intravascular Imaging
System, and accompanying Dualpro™ intravascular ultrasound and
near-infrared spectroscopy (IVUS+NIRS) catheter, is now available in
Japan. The launch follows a successful Spring 2018 limited market
release, which included more than 10 hospitals in Japan.

This press release features multimedia. View the full release here:
https://www.businesswire.com/news/home/20180731005224/en/

Infraredx announces the launch of the new Makoto™ Intravascular Imaging System and Dualpro™ IVUS+NIR ...

Infraredx announces the launch of the new Makoto™ Intravascular Imaging System and Dualpro™ IVUS+NIRS Catheter in Japan (Photo: Business Wire)

"Infraredx is proud to announce the release of the Makoto Intravascular
Imaging System and Dualpro IVUS+NIRS catheter in Japan, the world's
largest imaging market," said Jason Bottiglieri, President and CEO,
Infraredx. "IVUS+NIRS technology has the potential to dramatically
change the field of interventional cardiology. Two unique modalities in
one catheter provide cardiologists twice the information of other
imaging catheters, helping to inform personalized treatment decisions.
We thank our parent company Nipro for its significant role in advancing
our commitment to the diagnosis and management of coronary artery
disease."

The Makoto Intravascular Imaging System and Dualpro catheter is the only
technology on the market to identify vessel structure and plaque
composition using IVUS+NIRS. Its launch follows market approval from
Japan's Pharmaceuticals and Medical Devices Agency (PMDA) in August 2017.

"In Japan, we rely heavily on intravascular imaging during percutaneous
coronary intervention; so much so that is has become the standard of
care, with approximately 90 percent of angioplasty procedures employing
intravascular imaging," said Takashi Kubo, MD, PhD., Wakayama Medical
University. "The Makoto Imaging System and Dualpro catheter is the next
generation of imaging technology, providing superior deliverability and
lesion crossing ability as well as best-in-class image resolution to
easily identify the degree of stenosis and plaque burden."

Dualpro is the only imaging catheter on the market equipped with
extended bandwidth IVUS technology. By emitting and carefully processing
a broad band of frequencies, the Dualpro IVUS provides best-in-class
image resolution without compromising depth of field. Data collected
from the NIRS technology are translated into a Chemogram, an
easy-to-interpret, color-coded map to identify lipid core plaque (LCP),
which can help distinguish between stable plaque and dangerous LCP.
Coupled together, IVUS+NIRS arms cardiologists with unparalleled
insights into the role LCP plays in heart disease.

There are several global landmark studies, including the Lipid-Rich
Plaque (LRP) Study, currently underway, which underscore the importance
of identifying LCP for the prediction, and ultimately prevention, of
serious heart attacks. Results of the prospective, multi-center LRP
Study, along with a U.S. market launch of the Makoto Imaging System and
Dualpro IVUS+NIRS catheter, are anticipated in 2H 2018. The technology
is currently the only FDA-cleared dual-modality catheter and imaging
system indicated for the detection of LCP.

About the Makoto™ Intravascular Imaging System
The
Makoto™ Intravascular Imaging System, with accompanying Dualpro™
IVUS+NIRS catheter, is the only technology on the market to identify
vessel structure and plaque composition using IVUS+NIRS. Combining
best-in-class image resolution with insight into the composition of
plaque via Chemogram, IVUS+NIRS provides cardiologists with the tools
needed to potentially predict, and ultimately prevent serious heart
attacks.

About Infraredx, Inc.
Infraredx,
Inc., a Nipro company, is advancing the diagnosis and management of
coronary artery disease by providing cardiologists with the most precise
imaging tools required to predict and ultimately prevent heart attacks.
Its Makoto™ Intravascular Imaging System, with accompanying Dualpro™
IVUS+NIRS catheter, is the only technology on the market to identify the
arterial composition and structure using IVUS+NIRS. Infraredx is
dedicated to advancing this important field of research and conducting
landmark clinical trials to transform how we view and treat heart
disease. For more information, please visit www.infraredx.com
and connect with Infraredx on Twitter
and LinkedIn.

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