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

Description

PROJECT SUMMARY ABSTRACTAtrial fibrillationAFis a common and chronic cardiac arrhythmia that significantly increases morbiditymortalityand healthcare costsPost operative AF after cardiac surgery is especially commonIt complicates recovery in up toof patients undergoing coronary artery bypass surgeryIn the United States postoperative AF prolongs hospital stayincreases costand increases short and long term mortalityCorAmi is a biomedical startup company based in AtlantaGeorgia that has developed an effective treatment for post operative AFTheir therapeutic hydrogel and hydrogel delivery device have already been proven effective in a large animal studyThe technology consists of a hydrogel that delivers the drug amiodarone to the heart fordaysAmiodarone is a FDA approved medication effective for treating AFbut is not used long term because of its off target organ accumulation and toxicityCorAmi has also developed a hydrogel delivery device to position the amiodarone gel over the cardiac epicardium in the pericardial spaceThe purpose of this application is to adapt our minimally invasive delivery devicedesigned for use in the cardiac cath labto a surgical device to delivery amiodarone gel after open heart surgeryDelivery of amiodarone directly to the heart reduces toxicity and prevents AF fordays in our large animal preliminary studiesThe delivery device is essential for gel positioningmixingand drug incorporationCorAmi has an experienced management and scientific team including an experienced start up CEO supported by regulatoryscientificand device experienced executivesCorAmi has a well qualified scientific advisory board with cardiologistcardiac surgeonsand device engineers PROJECT NARRATIVE Post operative atrial fibrillation is the most common complication after cardiac surgeryaffecting up toof casesincreasing hospital length of staymortalityand healthcare costsCorAmi has designed a hydrogel that releases an effective medicationamiodaronedirectly onto the heart from the pericardial spaceThe goal of this application is to adapt our minimally invasive hydrogel delivery device to surgical use and stems from our extensive preliminary efficacy dataand draws on the expertise of our scientificregulatoryand business teams