Postoperative Atrial Fibrillation is an abnormal, irregular heart rhythm where electrical signals are generated apparently randomly throughout the upper chambers (atria) of the heart. The condition is the most common and significant complication of the more than one million cardiothoracic surgery procedures performed each year. Postoperative Atrial Fibrillation occurs in 20-40% of coronary bypass and 60% of heart valve repair patients.
According to various studies, the hospitalization time of bypass patients who experience atrial fibrillation is increased by an average of 2-4 days; time not reimbursed to the hospital. The economic impact of this prolongation exceeds $900 million per year in the U.S. alone. Aside from the economic impact, patients with persistent Postoperative Atrial Fibrillation have a significantly higher risk of stroke and other cardiovascular complications.
Currently, the onset of clinically relevant atrial fibrillation cannot be predicted in individual patients; advanced age is the only generally accepted risk factor.
Symphony Medical, a privately-held company developing proprietary biotherapeutics, uses biocompatible polymers and cell therapies to treat patients with heart failure and cardiac arrhythmias through non-ablative and non-surgical means. This is achieved, in part, by injecting biologic material directly into specific locations of the heart during either open chest surgery or via a minimally invasive procedure. Symphony’s products are classified by the FDA as devices and have a clear regulatory pathway and clinical end points.
Symphony’s initial product, Plexisyl-AF, has advanced from preclinical to human clinical stage testing. Plexisyl-AF is a prophylactic method of preventing sustained post-operative atrial fibrillation.
Symphony’s second product, Algisyl-LVR, currently in late stage preclinical testing, reshapes the dilated hearts of patients with chronic heart disease by injecting small quantities of a biopolymer into strategic areas of the left ventricle wall. Reshaping and thickening the ventricle wall reduces wall stress tone and provides lasting improvement of cardiac function.
Symphony’s third product, in early-stage preclinical testing, employs biotherapeutics delivered by catheter to the atrioventricular node region of the heart to regulate heart rate and rhythm in patients with chronic atrial fibrillation and other arrhythmias. The product aims to replace ineffective drug therapies, ablation techniques, and implantable devices (such as pacemakers) with a nondestructive, self-regulating biologic approach.Symphony has a strong intellectual property position with more than 20 issued or pending patents related to its technology.
A capital-efficient approach toward product development has allowed Symphony to achieve significant milestones with under $20 million in venture financing. The majority of research is conducted in the University setting and at commercial laboratories. The company’s near term goals include establishing the safety and efficacy of its biotherapeutics. To that end, two U.S. clinical studies are planned for 2008 including a first-in-man study for its heart failure product and a pivotal trial for its post-operative AF product. With solid evidence of efficacy Symphony believes its will be able to secure optimal strategic distribution alliances and licensing partnerships to maximize the value of its technologies.