Nipro, the exclusive distributor of Infraredx’s TVC imaging system in Japan, has set up a new subsidiary to commercially manufacture the TVC imaging systems.
Nipro and Infraredx have entered into a five-year distribution agreement in 2012 and are on track to receive regulatory approval from Japan’s Pharmaceuticals and Medical Device Agency in 2014.
Infraredx received $25m equity investment from Nipro in August 2013 and is expected to receive a minimum of $50m in revenues during the duration of the five-year agreement.
Infraredx president and CEO Don Southard noted Japan makes up 50% of the worldwide intravascular imaging market, thus representing a significant global growth opportunity for the company.
"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," Southard added.
The TVC imaging system is an intravascular imaging system with the unique ability to assess vessel composition and structure via integrated near infrared spectroscopy lipid core plaque detection and enhanced intravascular ultrasound imaging technology.
Through IVUS, the multimodality imaging system provides clear and relevant information about vessel structure, including lumen dimensions, degree of stenosis, and plaque burden.
Infraredx claims that it is the only device specifically approved in both the US and Europe for the detection of lipid core plaques.
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.