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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

public health problem. For many patients with severe asthma, even high doses of standard of care medications taken daily do not prevent frequent asthma attacks, which can be life-threatening," said Mario Castro, MD, Professor of Medicine at the Washington University School of Medicine, who presented data on the AIR2 Trial as the principal investigator. "We are hopeful that the FDA will concur with the recommendation made by the Panel today to make this procedure available to patients with severe asthma who have an enormous unmet medical need."

In the period immediately following bronchial thermoplasty, there is an expected transient 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 seven 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.

About Bronchial Thermoplasty Delivered by the Alair System

Bronchial thermoplasty is a non-drug procedure for asthma. The treatment is performed through the working channel of a standard flexible bronchoscope that is introduced through a patient's nose or mouth and into their lungs. The tip of the small diameter Alair catheter is expanded to contact the walls of targeted airways. Controlled thermal energy is then delivered to the airway walls to reduce the presence of airway smooth muscle that narrows the airways in patients with asthma. The minimally invasive procedure, like many other flexible endoscopy procedures, is done under light anesthesia, and the patient returns home the same day.

CAUTION: The Alair System is an Investigational Device. It is limited by United State
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SOURCE Asthmatx Inc.
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