Nipro Corporation (Osaka, Japan), which is the exclusive distributor of Infraredx's (Burlington, MA) TVC Imaging System, has established a manufacturing subsidiary to produce the system commercially. The TVC Imaging System is a multimodal imaging system that couples near-infrared (NIR) spectroscopy and intravascular ultrasound (IVUS) to help 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 (LCPs).
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In 2012, the two 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) this year. In August 2013, 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,” says 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.”
IVUS is the standard of care for coronary artery disease in Japan and used to guide more than 80 percent of all percutaneous coronary intervention (PCI) procedures.
The system 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.
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