AeriSeal® System Preliminary Trial Results Positive; Preparations for European Commercialization Underway
Woburn, MA – April 01, 2010 – Aeris Therapeutics (www.aerist.com), a company specializing in the development and commercialization of novel treatments for patients with emphysema and other advanced lung diseases, today announced the completion of enrollment in its European Study of the AeriSeal System. The AeriSeal System is designed to provide a safer non-surgical alternative to lung volume reduction surgery, one of the few available treatments for patients with advanced emphysema. The clinical trial is being conducted to support CE Mark approval that will lead to European commercialization anticipated in the second half of 2010. A total of 81 patients were enrolled in the study which is being conducted in two parts. The first part of the study, which included 25 patients with heterogeneous emphysema only, was designed to select an optimal treatment algorithm for continued evaluation. The second part of the study was designed to confirm the safety and efficacy of treatment with the AeriSeal System in both patients with heterogeneous emphysema and patients with homogeneous emphysema. “The data from the initial 25 patients demonstrated clinically significant improvements in breathing function and quality of life that were sustained at 6 months following completion of treatment. Despite the small patient sample size, these improvements were also statistically significant” commented Dr. David Dove, CEO of Aeris. “Based on these positive results and the completion of enrollment in the second stage of study, we are currently preparing to commercialize the AeriSeal System in Europe later this year.” The clinical study is being conducted at ten leading clinical centers in Germany, France, Austria and Israel. There are approximately 6 million patients with emphysema in Western Europe alone, of which more than 10% have advanced disease and could be potential candidates to benefit from a lung volume reduction treatment such as the AeriSeal System. “We are very encouraged by these results, which suggest that the AeriSeal System may be a significantly safer but still effective alternative to lung reduction surgery, an invasive procedure that involves a substantial degree of risk for emphysema patients,” commented Prof. Felix Herth, MD, the lead clinical investigator for the study in Germany and Chief of the Department of Pulmonology and Respiratory Medicine at Thoraxklinik in Heidelberg Germany. “There is a tremendous need for better options for the millions of people who suffer from emphysema.” About Emphysema and the AeriSeal System Emphysema is a progressive, debilitating disease of the lung that affects as many as 60 million people worldwide. Patients with emphysema currently have limited treatment choices. In recent years, lung volume reduction surgery, which involves the removal of diseased portions of the lung in order to enable the remaining portions of the lung to function better, has become an accepted but costly procedure for advanced emphysema. This surgery, although effective for many patients, is complicated and is associated with substantial morbidity and mortality risk, and is therefore infrequently performed. The AeriSeal System is intended to non-surgically reduce lung volume in order to improve lung function and quality of life in patients with emphysema. A bronchoscope is used to direct treatment to the most damaged areas of the patient’s lungs. AeriSeal Foam Sealant is delivered through the Catheter to the target areas where it polymerizes and seals the diseased lung regions. Over time, the sealed regions collapse, thereby reducing lung volume. About Aeris Therapeutics Aeris Therapeutics is an emerging medical therapeutics company specializing in the development and commercialization of novel treatments for patients with emphysema and other advanced lung diseases. Founded in 2001, Aeris Therapeutics is privately held, with corporate offices in Woburn, MA. Press Contact: David Dove, MD, MBA President & CEO (781) 937-0110 david.dove@aerist.com
