Infraredx Announces Nipro Corporation’s Plans for Commercial Manufacturing of TVC Imaging System in Japan

  Infraredx Announces Nipro Corporation’s Plans for Commercial Manufacturing
  of TVC Imaging System in Japan

  Japan-based Production Capability Supports Infraredx’s Planned Commercial
                  Expansion into Broader Asia Pacific Market

Business Wire

BURLINGTON, Mass. -- January 16, 2014

Infraredx, Inc., a medical device company committed to advancing the diagnosis
and management of coronary artery disease, today announced that Nipro
Corporation, the exclusive distributor of the TVC Imaging System in Japan, has
established a manufacturing subsidiary to commercially produce the TVC Imaging
System. In 2012, the companies entered into a five-year distribution agreement
and are on track to receive regulatory approval from Japan’s Pharmaceuticals
and Medical Device Agency (PMDA) in 2014. Last August, Infraredx received a
$25 million equity investment from Nipro, and is slated to receive a minimum
of $50 million in revenues during the duration of the five-year agreement.

“Japan makes up 50 percent of the worldwide intravascular imaging market, thus
representing a significant global growth opportunity for Infraredx,” said Don
Southard, president and chief executive officer of Infraredx. “The expansion
of manufacturing to Nipro’s new facility boosts our capacity to meet the
anticipated demand for the TVC Imaging System in Japan and supports our
commercialization efforts in China, Korea, and other emerging Asia Pacific

The TVC Imaging System console will be the first of nine products scheduled
for commercial manufacturing at the new facility in Yamanashi Prefecture, and
the start of production is slated for 2015.

Intravascular ultrasound (IVUS), one of the imaging technologies used by the
multimodal TVC Imaging System, is the standard of care in Japan and used to
guide more than 80 percent of all percutaneous coronary intervention (PCI)
procedures. The TVC Imaging System is the only device that offers IVUS
integrated with near-infrared spectroscopy (NIRS) for lipid core plaque
detection. The TVC Imaging System enables physicians to visualize the presence
of plaques, quantify the degree of vessel stenosis (narrowing) and identify
lipid core plaques suspected to be prone to rupturing and causing dangerous

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 the
risk of 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 specifically approved 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


Infraredx, Inc.
Mike Guarasci, Chief Financial Officer
Pure Communications, Inc.
Susan Heins (media), 864-286-9597
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