In addition, the company announced that the FDA has granted expedited review status to the Alair system. Bronchial thermoplasty with the Alair system is an investigational procedure that may change the standard of care for millions of asthma sufferers.
The first module of the Alair system premarket approval (PMA) application was filed with the FDA on July 2008, and the third and final module was submitted on December 30, 2008. The PMA submission is based on one-year data on 297 patients from the company’s pivotal trial, the Asthma Intervention Research 2 trial.
Glen French, CEO of Asthmatx, said: “We appreciate the FDA’s recognition of the potential importance of our catheter-based procedure for patients with severe asthma. In granting the Alair system expedited review status, the FDA commented that ‘the Alair system offers a breakthrough technology which has the potential to address an unmet clinical need within the asthma population’.”