Editor Note: The Heart Center at the University of Gottingen is also issuing a press release to announce the AUGMENT-HF clinical trial results.
ORLANDO, Fla., November 11, 2015 — LoneStar Heart, Inc. today presented and published the one-year extended follow-up results of AUGMENT-HF, an international randomized, multi-center clinical trial to evaluate the safety and efficacy of Algisyl. Classified as a medical device, Algisyl is a novel hydrogel that is implanted into specific areas of the failing heart muscle to improve cardiac function and clinical symptoms in advanced heart failure patients. Algisyl is approved for use in the European Union. The U.S. Food and Drug Administration recently approved an Investigational Device Exemption that allows the company to initiate a pivotal clinical study of Algisyl in the United States subject to certain conditions. Read more