The Venture Codex

Led · Equity · Aug 2013

Infraredx, based in Burlington, MA, develops the TVC Imaging System, an intravascular imaging platform that provides simultaneous structural and compositional vessel data in a single pullback. The company positions its technology to improve the safety and efficacy of coronary stenting and to support strategies aimed at preventing initial coronary events. Infraredx supplies practitioners with enhanced information for clinical decision making in treating coronary artery disease. To support its commercialization efforts, GE Capital amended Infraredx’s existing senior secured credit facility, increasing available capital. The amendment converted a $6.6 million senior secured facility into a $20 million facility by adding a $13.4 million multi-draw term loan. GE Capital, Healthcare Financial Services is acting as administrative agent for the credit facility. Infraredx makes the TVC Imaging System, a first-in-class intravascular imaging system that combines near-infrared spectroscopy (NIRS) lipid-core plaque detection with enhanced intravascular ultrasound (IVUS) to assess vessel composition and structure. The device provides true vessel characterization by delivering simultaneous structural and compositional imaging in a single pullback and is the only multimodality system available in the U.S. and Europe for lipid-core plaque detection. Infraredx plans to commercialize the TVC Imaging System in Japan through an exclusive distribution agreement with Nipro Corporation and expects Japanese regulatory approval in the first half of 2014. Proceeds from the recent financing will support the company’s expansion, operations and the Japan commercialization effort. Concurrent with the equity investment, Infraredx increased its term funding arrangement with GE Capital and a Nipro management team member will join Infraredx’s board. Founded in 1998 and headquartered in Burlington, Mass., Infraredx positions its technology to improve clinical decision making in coronary artery disease and to reduce complications during stenting. InfraReDx develops intelligent intravascular imaging technologies aimed at improving diagnosis and treatment of coronary and other vascular diseases. Its flagship product, the TVC Imaging System, is a first-in-class intravascular imaging platform that combines intravascular ultrasound (IVUS) and near-infrared spectroscopy (NIRS) in a single multimodality device. The TVC Imaging System is the only device cleared by the U.S. Food and Drug Administration for the detection of lipid core plaques of interest. The company intends to advance product commercialization efforts supported by recent financing. InfraReDx is based in Burlington, MA. Company leadership noted prior work with GE Capital and said the financing was structured to match its immediate and longer-term growth objectives. InfraReDx is a privately funded medical device company developing and commercializing intelligent cardiovascular diagnostic imaging technologies; it was founded in 1998 and is headquartered in Burlington, Massachusetts. Its core product is the LipiScan IVUS Coronary Imaging System, the first catheter to combine intravascular ultrasound (IVUS) and near-infrared (NIR) spectroscopy to detect and characterize lipid core coronary plaques. The system produces standard IVUS images and a Chemogram™ map in a single catheter pullback, indicating plaque location and quantifying lipid core burden to assist interventional cardiologists. InfraReDx received FDA approval and launched LipiScan in September 2010; the device is being utilized in a growing number of U.S. cardiac centers. The company plans to expand manufacturing operations and commercial infrastructure to meet accelerating physician demand and to support ongoing and new clinical trials investigating expanded clinical applications. The recent financing will fund commercialization expansion and further clinical studies to explore additional uses and benefits of the LipiScan system. InfraReDx is a Burlington, Massachusetts-based medical device company developing intelligent cardiovascular diagnostic imaging technologies. Its core product is the LipiScan™ IVUS Coronary Imaging System, a catheter that combines near-infrared spectroscopy (NIR) and intravascular ultrasound (IVUS). The device is designed to visualize and characterize intracoronary lipid core plaques (LCP) suspected of causing the majority of heart attacks. InfraReDx completed a $21M equity financing. The proceeds will support the full commercial launch of the LipiScan system.