Algisyl-LVR is a medical device under clinical development intended to prevent or reverse the progression of congestive heart failure (CHF) in patients who have an enlarged left ventricle as a result of mitral valve regurgitation, ischemia, dilated cardiomyopathy and/or other disorders.
The product consists of a proprietary biopolymer that is injected with a custom applicator during open heart surgery directly into strategic areas of the left ventricle muscle. As it is injected, the biopolymer thickens and forms gel-like bodies that remain in the heart muscle as permanent implants. These implants provide several beneficial functions: (i) they thicken the muscle wall, (ii) reduce chamber size, (iii) decrease local muscle wall stress, and based on the positioning of the implants, (iv) allow for a re-shaping of the dilated ventricle to impart it a healthier form. Based on the results of pre-clinical studies, these functions lead to a global improvement of the heart as measured by ejection fraction, systolic and diastolic pressures and other biomarkers of stress. The positive effect of the biopolymer implants is measurable within hours of the procedure and remains over the long term.
The biopolymer contained in Algisyl-LVR is a highly-purified polysaccharide sourced from marine algae that is manufactured for Cardio Polymers according to Good Manufacturing Practices. The material is highly biocompatible and essentially inert such that it does not interact with the human immune system. This allows the biopolymer to coexist permanently within the heart’s muscle. Considering that the material is passive and that it does not interact with the body in a pharmacologic sense, the U.S. Food and Drug Administration (FDA) has determined from a regulatory viewpoint that Algisyl-LVR is a device.
Algisyl-LVR has been extensively tested in pre-clinical models for over two years to establish its mode of action and tolerability. Algisyl-LVR was recently cleared for a human clinical study in Europe. The first patient received Algisyl-LVR in a procedure concomitant with a mitral valve repair at the German Heart Center in Munich under the direction of Prof. Dr. Robert Bauernschmitt. Other clinical centers in Germany, Norway, and Poland are expected to join the clinical study and begin enrolling patients in the spring of 2009. Cardio Polymers is currently working with the FDA to allow for clinical evaluation and eventual approval in the United States.
The Company believes that the approval pathway is reasonably well defined considering that the safety and efficacy endpoints for heart failure therapies are generally accepted. As a first step towards a commercial product, Cardio Polymers will focus on establishing the efficacy of Algisyl-LVR in CHF patients undergoing a planned cardiac surgery. This subset of the CHF population is substantially large and accounts for over 2 million patients in the U.S. alone.
Algisyl-LVR has not yet received market approval and is not currently marketed in any country. It is currently subject of a clinical investigation.