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| Infraredx's TVC Imaging System--Courtesy of Infraredx |
Infraredx isn't a big company yet. But the Massachusetts maker of an intravascular imaging system designed to help diagnose and manage coronary artery disease continues to meet major goals for international expansion. The latest: Japan's regulators granted approval for its signature device.
Specifically, Infraredx's TVC Imaging System and accompanying Insight catheter have a key sign-off from the Japanese Ministry of Health, Labor and Welfare. But Infraredx won't be going it alone in rolling out the product. Earlier this year, it began to put manufacturing and distribution partnership plans in place with Nipro, a Japanese conglomerate focused on medical devices and pharmaceuticals. Nipro subsidiary Goodman (which it partly owns) will distribute both the TVC Imaging System console and catheter. Previously, Goodman has been key to expanding markets in Japan for intravascular ultrasound imaging diagnostic devices for both Boston Scientific ($BSX) and Volcano, Infraredx said in a statement.
TVC is designed to seek out the details of coronary plaques that are connected to heart attacks and can make stenting more difficult, the company explained. It uses both near-infrared spectroscopy (NIRS) to spot lipid-core plaques and enhanced intravascular ultrasound (IVUS) to visualize the actual vessel structure.
This is a big milestone for Infraredx and is a good example of how smaller diagnostics companies can gain internationally by joining with far-larger partners and taking advantage of their international distribution systems. Burlington-based Infraredx and Nipro forged their initial partnership last August and Infraredx earned an initial $25 million equity investment as part of the deal.
Japan is also one of the largest medical markets in the world outside of the United States and commonly uses intravascular imaging for interventional cardiology procedures, the company noted.
Infraredx President and CEO Don Southard said as much in a statement disclosing the Japanese regulatory OK.
"The approval to market the TVC Imaging System in Japan marks an important milestone in our Asia-Pacific commercial expansion strategy," Southard said. "By combining NIRS and IVUS , two proven intravascular imaging modalities, the TVC Imaging System has the potential to add tremendous clinical value to the Japanese market."
Nipro also plans to commercialize the TVC system in China, Korea and additional Asia-Pacific countries, and so Infraredx gets the beachhead it wanted in its long-range Asia-Pacific strategy.
- read the release