ENDOMIMETICS LLC — Department of Health and Human Services SBIR Phase I: NHLBI

Description

The prevalence of atrial fibrillation in the US is approximately to million putting patients at significantly increased risk of cardioembolic stroke Approximately of all strokes are caused by atrial fibrillation Most atrial fibrillation is treated with blood thinners however some patients are at such high risk of bleeding that it prohibits anticoagulation Left atrial appendage closure devices LAAC have been developed to reduce the risk of clot embolism but they still require blood thinner use for at least days until the device interface has been covered by a healthy endothelial lining Endomimetics has developed a nanomatrix coating that enhances endothelial coverage and inhibits inflammatory responses and blood clot formation This nanomatrix can be coated on a LAAC device releasing nitric oxide NO over months enhancing endothelialization and neoendocardium formation The nanomatrix coating is a biocompatible peptide based material that is coated on the LAAC device by simple water evaporation More rapid healing could significantly shorten the duration of required blood thinner therapy In this Phase I SBIR we propose to evaluate and optimize the coating for LAAC devices This will include evaluation of physical characteristics and assessing effects on endothelial cell growth and migration as well as platelet adhesion In collaboration with Boston Scientific we will then evaluate the nanomatrix coated LAAC devices in vivo in an established canine LAAC model Developing a coating that promotes LAAC closure may have significant impact for the treatment of patients with atrial fibrillation who are at high risk for anticoagulation With successful completion of Phase I we plan to move forward in Phase II to larger scale GLP studies Atrial fibrillation is present in more than million people in the U S and is the cause of of all strokes Standard therapy requires blood thinners increasing patientsandapos risk of bleeding Patients who are at too high risk of bleeding to receive blood thinners receive a left atrial appendage closure LAAC device but this still requires blood thinners for at least days Endomimetics LLC has developed a coating for LAAC that could enhance healing on the LAAC device and shorten the need for blood thinners