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Symphony Medical
HCID Member | Medical Devices & Tech
26051 Merit Circle Ste 102
Laguna Hills, CA 92653 USA
phone:(949) 215-3613
fax:(949) 348-1866
Symbol Private
Founded 2002
Employees 9
          www.symphonymed.com
Research Sector Medical Devices & Tech
Summary Description
Biocompatible Polymers and Cell Therapies to Treat Heart Disease
Management
Raymond W. Cohen, Chief Executive Officer and member of the Board of Directors; Frank A. Ahmann, Chief Operating Officer; Sam L. Helgerson, Ph.D., Chief Scientific Officer; Andy G. Hinson, Vice President, Clinical and Regulatory Affairs; Roderick de Greef, Chief Financial Officer (Consultant)
Keywords
regurgitation, abnormalities, biotherapeutic, prophylactic, biocompatible

Comment | Printable Version | Modify profile Mar. 31, 2010

Description
Symphony Medical, Inc., is a privately-held development-stage company with proprietary biopolymer and biotherapeutic devices directed toward heart failure, post-operative atrial fibrillation (POAF) and other cardiac abnormalities.
Products / Services
The company has two products in its late-stage development pipeline. Algisyl-LVR is a treatment to prevent or reverse the progression of chronic heart failure and mitral valve regurgitation (MR). Plexisyl-AF is a prophylactic method of preventing sustained post-operative atrial fibrillation (POAF), a common side effect of the approximate 1 million coronary bypass and cardiac valve replacement surgeries performed each year.
Technology / Differentiation
Symphony'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's approach consists of implanting an inert, proprietary biocompatible biopolymer into the left ventricular wall to re-shape and thicken it, thus improving pumping efficiency and reducing LV wall stress. The implanted material coexists permanently with the heart's muscle.
Market / Customers
Chronic heart failure and mitral valve regurgitation related to dilated cardiomyopathy are lethal conditions in which a patient's heart loses functionality and blood-pumping capability. These conditions are responsible for over 300,000 deaths each year, and an estimated nine million Americans currently suffering from them. Algisyl-LVR targets over two million of these patients. Meanwhile, Plexisyl-AF targets approximately one million annual cardiac surgical patients and represents an annual market potential of over $800 million worldwide. Atrial fibrillation (AF) is the most common of cardiac abnormalities, with over 2 million Americans diagnosed.
Strategy
A capital-efficient approach toward product development has allowed Symphony to achieve significant milestones by conducting the majority of research in the university setting and at commercial laboratories. The company's near-term goals include establishing the safety and efficacy of its biotherapeutics.
Status
Algisyl-LVR has completed large animal preclinical testing and is planning a multi-center European clinical study for the first quarter of 2009. An IDE for Algisyl-LVR was filed with the FDA in December 2008. Plexisyl-AF has advanced to human clinical stage testing; a 32 patient safety study was completed in Europe in May 2008. An IDE will be filed in the first quarter of 2009 and a U.S. clinical study is planned for the second half of 2009.


2010-09-02-5548