Nipro Corporation to Commercialize Imaging System in Japan

Nipro Corporation, exclusive distributor of Infraredx Inc.’s TVC Imaging System, has established a Japanese manufacturing subsidiary to commercially produce the device.

The TVC Imaging System is a multimodal imaging system that couples near-infrared spectroscopy (NIRS) 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. In 2012, the companies signed a five-year distribution agreement; they are on track to receive regulatory approval this year from Japan’s Pharmaceuticals and Medical Device Agency. Last summer, 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,” Infraredx President/CEO Don Southard said. “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. 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 procedures. The TVC Imaging System offers IVUS integrated with NIRS for lipid core plaque detection. Infraredx claims its TVC 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.

The TVC Imaging System is an intravascular imaging system that provides information to evaluate 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 by providing vessel structure data in real time. The TVC Imaging System is the only device specifically approved in both the United States and Europe for the detection of lipid core plaques. NIRS measurements have been made in over 5,000 patients in over 100 hospitals worldwide.

Infraredx, Inc. is a privately-funded developer of coronary artery disease treatments. The 16-year-old company is headquartered in Burlington, Mass.