WOBURN, Mass.--(BUSINESS WIRE)--Aeris Therapeutics, LLC today announced that it received expanded CE Mark approval in Europe for the AeriSeal System, its recently commercialized non-surgical therapy for advanced emphysema. The expanded approval now allows patients to receive treatment at up to 4 lung regions in a single treatment session.
The expanded approval follows the availability of new clinical data from a study in which patients received treatment in two lung regions in each lung during a single bronchoscopic procedure. These study results will be presented at the upcoming Annual Congress of the European Respiratory Society on Sunday, September 25 by Professor Mordechai Kramer, Director of the Pulmonary Institute and Lung Transplantation Program at Rabin Medical Center, Tel Aviv, Israel and principal investigator in the study.
David Dove, MD, CEO of Aeris Therapeutics commented: “We are thrilled with the outcomes from our recent study with bilateral therapy and look forward to sharing these results with the pulmonary community at the European Respiratory Society meeting in Amsterdam later this month. The expanded CE Mark approval is an important milestone for Aeris. With this approval, clinicians are able to treat more damaged lung regions in a single treatment session, which results in better outcomes from a single minimally invasive procedure. We can now accelerate our global commercialization and scale up of clinical education and training programs and make this therapy available to more patients suffering from emphysema.”
About Emphysema and the AeriSeal System
Growing in global prevalence, emphysema is a progressive, debilitating disease of the lung that affects as many as 60 million people worldwide. Patients with advanced emphysema currently have limited treatment choices. In recent years, lung volume reduction surgery, which involves the removal of the most diseased portions of the lungs to enable the remaining areas of the lung to better function, has become an accepted but costly procedure for advanced emphysema. This surgery, although effective for many patients, is complicated and is accompanied by substantial morbidity and mortality and is therefore infrequently performed.
The AeriSeal System is intended to reduce lung volume without surgery in order to improve lung function and quality of life in patients with advanced emphysema. The AeriSeal System utilizes a proprietary polymer sealant that is delivered through a bronchoscope to the most damaged areas of the patient’s lungs. Over time, the sealed regions collapse, thereby reducing lung volume and improving respiratory function. The AeriSeal System procedure requires no special equipment, involves routine bronchoscopy technique, and is usually completed in less than 20 minutes.
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, Massachusetts, U.S.A.