IntraVascular Imaging, Inc. — Department of Health and Human Services STTR Phase I: NHLBI

Description

The goal of this Phase I STTR project is to constructoptimizeand test a clinically viable intravascular near infrared fluorescence intravascular ultrasoundNIRF IVUSimaging catheter for simultaneous molecular and structural diagnosis of coronary artery diseaseCADCAD is a worldwide leading cause of death and disabilityincluding acute myocardial infarctioncongestive heart failureand sudden cardiac deathMolecular processes such as inflammation drive devastating CAD and stent complicationsbut are largely invisible to contemporary clinical imaging methodsThe ability to image and quantify molecular processes will greatly improve our ability to improve CAD patient risk stratificationimprove percutaneous coronary interventionPCIprocedures at the point of careoptimally tailor CAD and stent pharmacotherapiesincluding PCSKinhibitorsand streamline new CAD and coronary stent product developmentIntravascular Imaging Inciin collaboration with MGH has developed novel and innovative intravascular imaging systems that combine high resolution IVUSthe current anatomical imaging standard of carewith NIRF molecular imaginga powerful new molecular imaging approachHoweverour prototype intracoronary NIRF IVUS catheter is too largeFrenchmmfor routine clinical coronary imagingIn order to enable clinical translational and commercialization of intracoronary NIRF imagingthis Phase I STTR objective is designconstructand miniaturize a NIRF IVUS imaging catheter for imaging smaller coronary arteries and to test it in vivoIn Aimiwill engineer miniaturized NIRF IVUS catheters for use in coronary arteriesandltFrenchmm diameterIn AimMGH will test the NIRF IVUS catheters in swine coronary arteries to obtain simultaneous in vivo coronary molecular structural imaging of plaque inflammation and plaque burdenThe anticipated results of this proposal will generate a highly translatablecoronary artery NIRF IVUS imaging catheter that can simultaneously image plaque inflammation based on NIRF molecular contrastand plaque structure based on IVUSFollowing successful completion of this projectiwill submit an SBIR STTR Phase II application to construct GMP grade intracoronary NIRF IVUS coronary artery imaging catheters and systemswith the goal of obtaining FDA IDE approval for first in human studiesThe long term objective of intracoronary NIRF IVUS is to improve the outcome of CAD patients entering the cardiac catheterization laboratory byABetter risk stratifying patients at risk of coronary plaque or stent complicationsBIdentifying the higher risk CAD patients likely to benefit from PCSKinhibitor therapyand CComprehensively assessing the molecular and structural efficacy of novel CAD pharmacotherapeutics and new stents in Phase IIa IIb and Phase III clinical trials PROJECT NARRATIVE New methods are needed to identify patients that will suffer heart attacks and sudden cardiac death from coronary plaque and stent complicationsThis Project willfor the first timecombine two intravascular imaging methods based on lightnear infrared fluorescenceand soundultrasoundinto a clinically and commercially viable catheter systemNIRF IVUSthat can simultaneously image the biology and structure of coronary artery diseaseThe new knowledge gained from intracoronary NIRF IVUS will eventually better identify patients at higher risk of coronary plaques and stent complicationsguide the selection of the medicines to reduce these complicationsand provide a new approach to streamline the development of new drugs and stents designed to treat coronary disease