BURLINGTON, Mass.--(BUSINESS WIRE)--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 markets.”
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 blockages.
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 www.infraredx.com.