Infraredx Inc. has announced that Nipro Corp., the exclusive distributor of its TVC Imaging System in Japan, has established a manufacturing subsidiary in Yamanishi that will produce biomedical devices. Nipro and Infraredx signed a five-year distribution agreement in 2012. Regulatory approval from Japan’s Pharmaceuticals and Medical Devices Agency, which is required to manufacture the product, is expected in 2014, and production is scheduled to begin in 2015. The TVC Imaging System uses intravascular ultrasound and NIR spectroscopy to monitor coronary artery disease by evaluating vessel structure and composition, and by monitoring for plaque and stenosis. “Japan makes up 50 percent of the worldwide intravascular imaging market… representing a significant global growth opportunity,” said Don Southard, president and CEO 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 is the first of nine products slated for commercial manufacture at the Nipro facility. For more information, visit: www.infraredx.com