Atrial fibrillation (AF) is a common and chronic cardiac arrhythmia that significantly increases morbidity, mortality, and healthcare costs. Post-operative AF after cardiac surgery is especially common. It complicates recovery in up to 40% of patients undergoing coronary artery bypass surgery. In the United States post- operative AF prolongs hospital stay, increases cost, and increases short and long term mortality. CorAmi is a biomedical startup company based in Atlanta, Georgia that has developed an effective treatment for post-operative AF. Their therapeutic hydrogel and hydrogel delivery device have already been proven effective in a large animal study. The technology consists of a hydrogel that delivers the drug amiodarone to the heart for 30 days. Amiodarone is a FDA-approved medication effective for treating AF, but is not used long term because of its off-target organ accumulation and toxicity. CorAmi has also developed a hydrogel delivery device to position the amiodarone gel over the cardiac epicardium in the pericardial space. The purpose of this application is to adapt our minimally invasive delivery device ? designed for use in the cardiac cath lab ? to a surgical device to delivery amiodarone gel after open heart surgery. Delivery of amiodarone directly to the heart reduces toxicity and prevents AF for 30 days in our large animal preliminary studies. The delivery device is essential for gel positioning, mixing, and drug incorporation. CorAmi has an experienced management and scientific team including an experienced start up CEO supported by regulatory, scientific, and device experienced executives. CorAmi has a well-qualified scientific advisory board with cardiologist, cardiac surgeons, and device engineers.
Post-operative atrial fibrillation is the most common complication after cardiac surgery, affecting up to 40% of cases, increasing hospital length of stay, mortality, and healthcare costs. CorAmi has designed a hydrogel that releases an effective medication, amiodarone, directly onto the heart from the pericardial space. The goal of this application is to adapt our minimally invasive hydrogel delivery device to surgical use and stems from our extensive preliminary efficacy data, and draws on the expertise of our scientific, regulatory, and business teams.
