Infraredx Receives $25 Million Investment from Nipro Corporation

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 5000 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.