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.