Infraredx Receives $25 Million Investment from Nipro Corporation

  Infraredx Receives $25 Million Investment from Nipro Corporation

 Investment Will Support Commercialization of the TVC Imaging System in Japan

Business Wire

BURLINGTON, Mass. -- August 22, 2013

Infraredx, Inc., a medical device company committed to advancing the diagnosis
and management of coronary artery disease, today announced that it has
received a $25 million equity investment from Nipro Corporation. This
investment builds on Infraredx’s exclusive agreement with Nipro for
distribution of its TVC Imaging System in Japan, the world’s largest
intravascular imaging market. In conjunction with the investment, a member of
Nipro’s management team will join Infraredx’s board of directors.

The TVC Imaging System is a first-in-class intravascular imaging system that
integrates near infrared spectroscopy (NIRS) lipid core plaque (LCP) detection
and enhanced intravascular ultrasound (IVUS) imaging technology to assess
vessel composition and structure.

“Nipro’s investment in Infraredx underscores the significant potential of our
TVC Imaging System to change the standard of care for patients with coronary
artery disease,” said Donald Southard, president and chief executive officer
of Infraredx. “We are pleased to welcome Nipro as an investor and to our board
of directors. For the past year, we have been working closely with Nipro to
secure regulatory approval and ultimately launch the TVC Imaging System in
Japan. Concurrent with Nipro’s investment, Infraredx has increased its term
funding arrangement with GE Capital.With the equity investment by Nipro and
the increased term funding, the company is well capitalized to achieve our
objective of introducing our technology in every major imaging market around
the world.”

Proceeds from this investment will be used to support Infraredx’s expansion,
operations and the commercialization of the TVC Imaging System in Japan. The
companies are on track to receive Japanese regulatory approval of the TVC
Imaging System in the first half of 2014.

IVUS imaging is the standard of care in Japan with more than 80 percent of all
percutaneous coronary intervention (PCI) procedures guided by intravascular
imaging. However, while IVUS can reveal the structure of a vessel and the
presence of plaque, it is not an optimal method to determine plaque
composition and whether it contains a lipid core. Lipid core plaque is a fatty
coronary artery plaque suspected to be vulnerable to rupture and cause most
heart attacks. LCP is also known to complicate stenting procedures, and new
studies indicate that LCP is present within the culprit lesion of a high
number of patients with ST-Elevation Myocardial Infarction, a dangerous type
of heart attack. The TVC Imaging System is the only device that offers
physicians both NIRS to detect lipid core plaque combined with IVUS for true
vessel characterization.

“Infraredx’s novel TVC Imaging System will provide Japanese cardiologists with
critical imaging information, enabling physicians the ability to deliver the
most informed interventional therapies to their patients,” said Yoshihiko
Sano, president and chief executive officer of Nipro Corporation. “Our
strategic investment in Infraredx builds upon our productive relationship with
the company and demonstrates our confidence that its technology will play an
important role in our long-term strategy to grow our vascular business unit
annual sales turnover to more than 30 billion yen by the year 2020.”

About The TVC Imaging System™

The TVC Imaging System™ is a first-in-class intravascular imaging system that
holds the potential to revolutionize the management of coronary artery disease
by providing information that is critical for evaluating vessel structure and
composition, also known as true vessel characterization. The TVC Imaging
System helps interventional cardiologists identify which patients are prone to
complications during stenting. The device enables cardiologists to predict
peri-procedural heart attacks by assessing not only the degree of stenosis,
but also the presence and extent of lipid-core plaques (LCP).

The device is the only multimodality imaging system to combine both
intravascular ultrasound (IVUS) and near-infrared spectroscopy (NIRS). Through
IVUS technology, the TVC Imaging System provides clear and relevant
information about vessel structure, in real time. The TVC Imaging System is
the only device available in both the U.S. and Europe for the detection of
LCPs. NIRS measurements have been made in over 5,000 patients in over 100
hospitals worldwide.

About Infraredx, Inc.

Infraredx, Inc. is a privately-funded medical device company dedicated to
helping provide practitioners with the information needed for enhanced
clinical decision making in treating coronary artery disease. The company is
committed to improving the safety and efficacy of coronary stenting and
ultimately serving as part of a strategy to prevent initial coronary events.

Through its TVC Imaging System™, Infraredx is changing the way coronary artery
disease is diagnosed and treated. The TVC Imaging System is the only
intravascular imaging system that enables true vessel characterization through
simultaneous structural and compositional imaging data obtained in a single
pullback. Founded in 1998, Infraredx is headquartered in Burlington, Mass. For
more information, visit www.infraredx.com.

Contact:

Infraredx, Inc.
Mike Guarasci, 781-345-9648
Chief Financial Officer
mguarasci@infraredx.com
or
Pure Communications, Inc.
Susan Heins, 864-286-9597
sjheins@purecommunicationsinc.com