European Trials Commencing for Injectable Biopolymer to Repair Weakened Heart Wall
LAGUNA HILLS, Calif., April 14 /PRNewswire/ -- Symphony Medical, Inc., a developer of novel biopolymer therapies to cardiac abnormalities, announced today that its patented flagship technology, Algisyl-LVR(R), was used on a human for the first time, successfully treating a 50-year-old male who was suffering from chronic heart failure.
The Company intends to sponsor a clinical study of Algisyl-LVR at four centers in Europe, including the German Heart Center in Munich where the first procedure was performed, and is also seeking an Investigational Device Exemption from the U.S. Food and Drug Administration in order to conduct a follow-on U.S. study.
Algisyl-LVR is an implantable medical device under clinical development intended to prevent or reverse the progression of congestive heart failure in patients who have an enlarged left ventricle. The procedure, which is performed on patients undergoing a planned cardiac surgery for mitral valve regurgitation or coronary artery disease, involves injecting a proprietary biopolymer directly into strategic locations of the heart's left ventricle wall. As it is injected, the biopolymer thickens and forms firm, gel-like structures that remain in the heart muscle as permanent implants. These implants act to re-shape the heart, reduce the size of the dilated left ventricle and thicken the damaged wall of the heart, thus returning the heart to a healthier form that facilitates improved cardiac function and performance.
The first Algisyl-LVR patient was successfully treated by Prof. Dr. Robert Bauernschmitt. The condition of the patient, who had been bedridden, was deteriorating due to a poorly performing heart mitral valve which contributed to congestive heart failure. During the surgery to repair the valve, the cardiac surgeon implanted the Algisyl-LVR. Four days following the procedure, the patient's ejection fraction, a measure of the heart's pumping ability, more than doubled, the size of his ventricle was reduced by 22 percent and his ventricle wall thickness increased by 23 percent. By day eight, the patient was able to walk unassisted. He was subsequently discharged from the hospital in a considerably improved condition.
Prof. Dr. Bauernschmitt said, "We are extremely pleased with the initial outcome of the first patient treatment with Algisyl-LVR. The administration of this implantable biopolymer to the heart wall provides a practical new tool to prevent and even reverse the dilation of the left ventricle, which is typical in congestive heart failure. As such, this new therapy has the potential to provide significant health benefits to a growing population of patients. While it is still very early, the initial outcome of Algisyl-LVR suggests that the therapy is feasible and safe while it provides immediate, tangible benefits. We look forward to treating additional patients here at the German Heart Center."
Raymond W. Cohen, Symphony Medical chief executive officer said, "As one might imagine, the physician, the patient, and all of us at Symphony are quite energized with this remarkable result. Algisyl-LVR results from years of research and an exhaustive number of pre-clinical studies which demonstrated safety and impressive efficacy. Given that congestive heart failure is a lethal and complex disease, positive pre-clinical data does not always translate into success with humans; however, it is notable that there was an excellent correlation between our pre-clinical data and the first human results. We look forward to treating more patients and establishing Algisyl-LVR as an important new therapy to increase the quality of life of patients suffering from congestive heart failure."
About Symphony Medical, Inc.
Symphony Medical, founded in 2003, is a privately-held, venture-backed development stage company developing proprietary biotherapeutic products and tools to address the unmet clinical needs of millions of patients suffering from cardiac disorders. Headquartered in Orange County, California, the Company's products employ proprietary biocompatible polymers delivered into specific locations of the heart during either open chest surgery or via a minimally invasive procedure. The biopolymers are engineered to achieve clinical benefit by locally modifying cardiac physiology. Symphony's products are classified by the FDA as devices and have a clear regulatory pathway and clinical end points.
The Company has two products in its late-stage development pipeline - Algisyl-LVR(R) for the treatment to prevent or reverse the progression of chronic heart failure (CHF) and mitral valve regurgitation (MR), conditions affecting well over 5 million Americans. Symphony's approach involves implanting a space-occupying biocompatible polymer into strategic areas of the heart's left ventricle (LV) wall to affect LV shape and prevent or reverse LV enlargement. Reshaping and thickening the LV wall reduces wall stress, reduces mitral valve regurgitation and provides lasting improvement of cardiac function with an associated improvement in the patient's clinical status and quality of life. Algisyl-LVR has advanced to human clinical studies with a first-in-man study initiated in February 2009. Plexisyl-AF(R) a prophylactic method of preventing sustained post-operative atrial fibrillation (POAF), a common side effect of the approximately 1 million coronary bypass and cardiac valve replacement surgeries performed each year. Plexisyl has advanced to human clinical stage testing. A 32-patient safety study was completed in Europe in May 2008.
For more information on Symphony Medical please visit our website at www.symphonymed.com.
CONTACT: Matt Clawson of Allen & Caron Inc, +1-949-474-4300,
email@example.com, for Symphony Medical, Inc.
Web site: http://www.symphonymed.com/