SUNNYVALE, CA--(MARKET WIRE)--Jan 12, 2009 -- Asthmatx, Inc., a medical device company that has developed a catheter-based procedure for the treatment of severe asthma, announced today that it has submitted its pre-market approval (PMA) application for the Alair® Bronchial Thermoplasty System to the U.S. Food and Drug Administration (FDA). In addition, the Company announced that 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 PMA was filed with FDA last July, 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 (AIR2) Trial. The AIR2 Trial was a multicenter, randomized, double-blind, sham-controlled clinical trial of bronchial thermoplasty with the Alair System 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.
"We appreciate FDA's recognition of the potential importance of our catheter-based procedure for patients with severe asthma," commented Glen French, chief executive officer of Asthmatx. "In granting the Alair System Expedited Review status, FDA commented that 'The Alair System offers a breakthrough technology which has the potential to address an unmet clinical need within the asthma population.'"
Asthma is one of the most common and costly diseases in the world. The prevalence of asthma has grown in recent decades, and there is no known cure. According to the American Lung Association, more than 20 million Americans have asthma, and about two-thirds of these patients are adults. Managing unstable asthma consumes billions of dollars of healthcare resources each year. Each year in the U.S., asthma attacks result in approximately 10 million unscheduled doctor office visits, 2 million emergency rooms visits, 500,000 hospitalizations, and 4,000 deaths.
"Unfortunately, despite an array of generally effective medications, there are still many severe asthma patients who either do not respond adequately to drugs, do not have access to appropriate treatment, or simply choose not to take their medications," states Mario Castro, MD, Professor of Medicine and Pediatrics, Washington University School of Medicine, St. Louis, MO, and a Principal Investigator in the AIR2 Trial. "There is a significant unmet medical need to improve the care for patients with severe asthma by better controlling their asthma symptoms. Bronchial thermoplasty offers significant, clinically meaningful advantages over and above currently available medications for severe asthma."
To date, the total clinical experience with the Alair System includes over 800 bronchial thermoplasty bronchoscopies with long-term follow up data available. The earliest subjects have been followed for five years post-treatment. "We are encouraged by the consistency of the data that we have seen across four clinical studies in patients with asthma," states Gerard Cox, MB, Professor of Medicine, McMaster University, Canada, and an investigator in all four bronchial thermoplasty clinical studies. "The results of the randomized trials show a significant and persistent improvement in asthma control and quality of life in patients with severe asthma."
About the procedure
Bronchial thermoplasty is the first non-drug treatment 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 procedure, like many other flexible endoscopy procedures, is done under light anesthesia, and the patient returns home the same day. 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, and resolve on average within 7 days with standard care.
CAUTION: Alair System is an Investigational Device. It is limited by United States law to investigational use. To be used by Qualified Investigators only.
Alair is a registered trademark of Asthmatx, Inc.
Asthmatx is developing catheter-based medical devices for the treatment of asthma. Asthmatx has developed the Alair System to perform an investigational outpatient procedure called bronchial thermoplasty. Bronchial thermoplasty involves the delivery of precisely controlled thermal energy to the airway wall, to reduce the amount of airway smooth muscle, and lessen these muscles' ability to narrow the airway. For more information on Asthmatx visit www.asthmatx.com. The Alair System has received a CE Mark to sell the device in the European Union.