Algisyl® is a medical device under clinical development intended to prevent or reverse the progression of Advanced Heart Failure in patients who have an enlarged left ventricle as a result of a myocardial infarct, mitral valve regurgitation, ischemia, arrhythmias, and/or other disorders. The product consists of an injectable proprietary biopolymer (hydrogel) that is administered directly into strategic areas of the left ventricle muscle. 10-19 injections are made into the left ventricle wall, and the hydrogel thickens and forms gel-like bodies of polymer that remain in the heart muscle as permanent implants, acting to reduce left ventricular wall stress, increase pumping efficiency and mitigate further dilation and negative remodeling of the left ventricle.
Algisyl® represents a new treatment strategy based on the medically accepted principle that a reduction in muscle tension and cell stress will improve the function of the dilated left ventricle of the heart. In both animal and human studies, Algisyl hydrogel implantation within the ventricle muscle wall has been shown to relieve the muscle tension and wall stress of the dilated heart. These studies indicate not only significant improvements in pumping efficiency (the “ejection fraction”) and other cardiomechanical parameters, but also positive biological effects such as localized capillary and tissue regeneration.
Treatment does not interfere with drug therapies and the regular management of Heart Failure patients including the use of LVAD’s, valve or bypass surgery or transplantation. It consists of a one-time procedure that can be conducted efficiently and cost-effectively. In contrast to active implantable devices that require a power source such as a battery, Algisyl® is passive and requires minimal care following its implantation.
Two product versions are being developed that target different physician segments and will be marketed separately. In the surgical product version the alginate is delivered using a customized delivery system which includes a syringe, extension set and special needle designed for the Cardiothoracic surgeon to perform the injections. These can be done in a standalone procedure via a minimally invasive thoracotomy operation or in combination with another surgical procedure like a valve replacement or bypass surgery via a sternotomy.
The safety and clinical efficacy of Algisyl® implants have been demonstrated in two clinical studies with results that were published in peer-reviewed journals and presented at international cardiology conferences. In particular, AUGMENT-HF, a randomized controlled trial carried out in Europe, established statistically significant and durable superiority for Algisyl® patients relative to a control group under optimal medical therapy for key efficacy endpoints at 6-month and 12-month follow-up. CE-mark approving the commercialization of the surgical version of Algisyl® in Europe was granted in late 2014 allowing for the initial launch phase.