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Pivotal Data Show Bronchial Thermoplasty Can Improve Quality of Life and Reduce Asthma Attacks and Emergency Room Visits for Adults with Severe Asthma
Date:5/18/2009

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  • 4 out of 5 Alair-treated patients responded with a clinically significant improvement in AQLQ compared to 64% of sham controls
  • 32% reduction in asthma attacks
  • 84% reduction in emergency room visits for respiratory symptoms
  • 36% reduction in patients reporting episodes of asthma (multiple symptoms) adverse events
  • 66% reduction in days lost from work/school or other activities due to respiratory symptoms

  • In the period immediately following bronchial thermoplasty, there is an expected increase and worsening of respiratory-related symptoms, which are of the type expected following bronchoscopy in patients with asthma. These events typically occur within a day of the procedure and resolve on average within 7 days with standard care. In the long term, fewer bronchial thermoplasty treated patients reported respiratory adverse events and there was a significant decrease in patients reporting asthma (multiple symptoms) adverse events in the Alair-treated group compared to the sham control group.

    "The results from AIR2, similar to the results from two prior randomized clinical trials evaluating the Alair System, demonstrate that patients with severe asthma can experience clinically significant improvements in their asthma control and their quality of life," said Glen French, CEO of Asthmatx.

    The results of this pivotal study have enabled Asthmatx to submit a Premarket Approval application (PMA) to the FDA for regulatory approval. The FDA granted the Alair System PMA Expedited Review Status in October 2008, based on its potential "to treat asthma, a life-threatening/debilitating disease" and because the "Alair System offers a breakthrough technology which has the potential to address an unmet clinical need within the asthma population."

    "Participation in the AIR2 Trial required a
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    SOURCE Asthmatx, Inc.
    Copyright©2009 PR Newswire.
    All rights reserved

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