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Asthmatx Submits PMA Seeking FDA Approval For A New Device-Based Procedure To Treat Severe Asthma

Asthmatx, Inc. has announced that the company has submitted its pre-market approval (PMA) application to the US FDA for the Alair Bronchial Thermoplasty System. The Company has also announced that FDA has granted Expedited Review status to the Alair System. The company expects that an investigational procedure, Bronchial thermoplasty with the Alair System may change the standard of care for asthma sufferers. Asthmatx has filed the first module of the Alair System PMA with US FDA in July, 2008 and the third and final module was submitted on December 30, 2008. The PMA submission for the Alair System was based on one-year data of 297 patients from the Company's pivotal trial, the Asthma Intervention Research 2 (AIR2) Trial. AIR2 Trial is a multicenter, randomized, double-blind, sham-controlled clinical trial of bronchial thermoplasty with the Alair System. This trial is conducted to demonstrate the safety and effectiveness of bronchial thermoplasty in adults with severe asthma. The primary effectiveness endpoint was the change from baseline in Asthma Quality of Life Questionnaire (AQLQ) score. Safety was assessed by comparing the short and long-term safety profiles for both groups. The total clinical experience with the Alair System till date includes over 800 bronchial thermoplasty bronchoscopies with long-term follow up data available. The earliest subjects have been followed for five years post-treatment.