Aeris Therapeutics, Inc. Announces CE Mark Approval for the AeriSeal(R) Emphysematous Lung Sealant System
WOBURN, Mass.--(BUSINESS WIRE)--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 that it has received CE Mark approval for its 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 CE Mark approval enables the Company to move forward with commercialization in Europe and other select markets.
David Dove, MD, President & CEO of Aeris Therapeutics commented, "The attainment of the CE Mark represents the achievement of another significant milestone in Aeris' mission to improve the lives of patients with advanced lung diseases. The timing of this approval coincides with the presentation by investigators of positive clinical outcomes from our EU clinical trials at the 2010 Annual Congress of the European Respiratory Society in Barcelona this week. It allows us to promptly address immediate demand for new therapies for emphysema in the EU, a potential $7 billion market opportunity.”
Prof. Felix Herth, MD, Chief of the Department of Pulmonology and Respiratory Medicine at Thoraxklinik in Heidelberg, Germany and Principal Investigator of the AeriSeal System clinical study added, “This innovative approach provides an important treatment alternative to invasive options such as lung transplantation and Lung Volume Reduction Surgery. The opportunity to now offer the AeriSeal System to our patients with advanced emphysema in Germany represents a significant advance in the field that will enable us to more effectively treat patients with this difficult disease.”
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 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 advanced 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.