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Infraredx Announces an Exclusive Distribution Agreement for its TVC Imaging System with Nipro Corporation in Japan

Wed, 06/27/2012 - 8:30am
The Associated Press

BURLINGTON, Mass.--(BUSINESS WIRE)--Jun 27, 2012-- Infraredx, Inc., a medical device company committed to advancing the diagnosis and management of coronary artery and other vascular diseases, today announced that the company has signed an exclusive five-year agreement with Nipro Corporation to distribute the TVC Imaging System(TM) for true vessel characterization of coronary artery disease in Japan. This agreement expands Infraredx's presence into Asia and demonstrates the company's commitment to make the TVC Imaging System available worldwide. 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.

Under the terms of the agreement, Infraredx will receive a minimum of $50 million in revenues over the duration of the agreement. Nipro will be responsible for obtaining marketing authorization for the TVC Imaging System and catheter with Japan's Pharmaceuticals and Medical Device Agency (PMDA). Additionally, Nipro will be responsible for all sales, marketing and promotion of the TVC System, including clinical education and physician training in the operation of the TVC system as well as all field service and technical support of the TVC System. The agreement is contingent upon a Shonin (product approval) by the Japanese regulatory authorities. The companies anticipate approval and subsequent launch of the TVC Imaging System in Japan in 2013.

"Japan is the world's largest intravascular imaging market and as such represents a tremendous commercial opportunity for Infraredx," said Donald Southard, president and chief executive officer of Infraredx.

"Our agreement with Nipro is another major milestone in our global commercialization strategy as we continue to expand access to the TVC Imaging System. As a global life sciences leader, Nipro is the perfect partner to bring the TVC Imaging System to the Japanese market. The company has extensive in-depth knowledge of the medical device and cardiovascular imaging space, and is committed to providing innovative products that meet the needs of healthcare professionals and improve the quality of life for patients." IVUS has become 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 display the structure of a plaque, it is not an optimal method to determine its composition and if 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. It is also known to complicate stenting procedures either during or following the placement of coronary artery stents. The TVC Imaging System is the only device that offers physicians both IVUS and NIRS to improve characterization of the vessel.

"We are delighted to partner with Infraredx on the sales and marketing of the TVC Imaging System in Japan," said Yoshihiko Sano, president of Nipro Corporation. "We have received positive feedback from Japanese interventional cardiologists on the clinical value of the TVC Imaging System and its unique intravascular imaging capabilities. The device enables physicians to identify lipid core plaque in patients who are at risk of developing stenting complications during PCI, which can lead to more precisely tailored treatment strategies. We plan to submit the regulatory package to the PMDA in the coming weeks and look forward to introducing the TVC Imaging System to the market next year." About TVC Imaging System(TM) The TVC Imaging System(TM) 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) of interest.

In a single pullback, the TVC Imaging System provides rapid and automated detection of LCPs during the cardiac catheterization procedure. 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 system's enhanced IVUS image provides a clear view of the vessel and plaque, providing more reliable vessel interpretation and assessment. The system's NIRS technology enables interventional cardiologists to reliably visualize the presence of LCP and predict the risk of peri-stenting myocardial infarction. The multimodality images are obtained simultaneously and require no post-processing or image manipulation. The TVC Imaging System is the only device available in both the U.S. and Europe for the detection of LCPs.

Outside of the U.S., the TVC Imaging System is available in more than 30 countries 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(TM), 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. Through the use of both intravascular ultrasound (IVUS) and near-infrared spectroscopy (NIRS) technologies, the system helps interventional cardiologists identify which patients are prone to stenting complications by assessing not only the degree of stenosis, but also the presence of lipid core plaque. Founded in 1998, Infraredx is headquartered in Burlington, Mass. For more information, visit www.infraredx.com.

CONTACT: Media Contact: Pure Communications, Inc.

Susan Heins, 864-286-9597 sjheins@purecommunicationsinc.com or Infraredx, Inc.

Grant Frazier, 781-345-9632 Vice President of Marketing gfrazier@infraredx.com KEYWORD: UNITED STATES NORTH AMERICA MASSACHUSETTS INDUSTRY KEYWORD: HEALTH BIOTECHNOLOGY CARDIOLOGY MEDICAL DEVICES PHARMACEUTICAL SOURCE: Infraredx, Inc.

Copyright Business Wire 2012 PUB: 06/27/2012 08:30 AM/DISC: 06/27/2012 08:30 AM http://www.businesswire.com/news/home/20120627005212/

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