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Asthmatx Receives FDA Advisory Panel Recommendation for Approvable with Conditions for Bronchial Thermoplasty with the Alair(R) System for Severe Asthma
Date:10/28/2009

GAITHERSBURG, Md., Oct. 28 /PRNewswire/ -- Asthmatx Inc., announced today that the Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee to the U.S. Food and Drug Administration (FDA) voted to recommend that the Alair® System, a device utilized in bronchial thermoplasty for the treatment of severe persistent asthma in patients 18 years and older, be found approvable with conditions.

The Anesthesiology and Respiratory Therapy Devices Panel voted 6 to 1 in favor of approvable with conditions, which were primarily related to labeling and post-approval studies. The final decision regarding the approval of the device is made by the FDA and while the FDA is not required to follow the advice of its advisory committee, it generally does.

"The Advisory Panel's recommendation for approvable with conditions of the Alair System marks a major step in bringing this new and important treatment option to patients with severe asthma," said Glen French, CEO of Asthmatx. "We look forward to working with FDA through the next steps to product approval."

Bronchial thermoplasty is a novel, non-drug procedure developed to treat adults with severe asthma and is designed to provide improved asthma quality of life and control that lasts for at least one year. Bronchial thermoplasty delivered by the Alair System uses thermal energy to reduce the muscle associated with airway constriction in asthma patients. The Committee reviewed the results of the AIR2 Trial, which found that in the year following bronchial thermoplasty, treated patients with severe asthma experienced the following benefits:

  • Significant improvement in quality of life
  • 32 percent reduction in severe asthma attacks
  • 84 percent reduction in emergency room visits for respiratory symptoms
  • 66 percent reduction in days lost from work/school or other activities

"Asthma is a serious
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SOURCE Asthmatx Inc.
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