Infraredx Plans Commercial Manufacturing of TVC Imaging System in Japan
January 28, 2014
January 28, 2014 — Infraredx Inc.’s TVC Imaging System will be manufactured and distributed in Japan by Nipro Corp. Infraredx intends to commercialize the TVC Imaging System in Japan, China, Korea and other Asia Pacific markets.
The companies entered a five-year distribution agreement in 2012 and anticipate regulatory approval from Japan’s Pharmaceuticals and Medical Device Agency (PMDA) in 2014. Infraredx received a $25 million equity investment from Nipro in August 2013, and anticipates a minimum of $50 million in revenues during the duration of the agreement.
The TVC Imaging System console will be the first of nine products scheduled for commercial manufacturing at the new facility in Yamanashi Prefecture. Production is scheduled to begin in 2015.
Intravascular ultrasound (IVUS), one of the imaging technologies used by the multimodal TVC Imaging System, is the standard of care in Japan and is used to guide more than 80 percent of percutaneous coronary intervention (PCI) procedures. The TVC Imaging System offers IVUS integrated with near-infrared spectroscopy (NIRS) for lipid core plaque detection. The TVC Imaging System can enable 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 intends to aid physicians evaluate true vessel characterization for treating coronary artery disease. The TVC Imaging System helps interventional cardiologists identify which patients are prone to complications during stenting and 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 approved in both the United State and Europe to detect LCPs. NIRS measurements have been made in over 5,000 patients in over 100 hospitals worldwide.
For more information, visit www.infraredx.com.