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First Patient in the US is Treated With Investigational Outpatient Procedure for Asthma

Posted on: Tuesday, 18 April 2006, 09:01 CDT

FDA Approved IDE Study Utilizes Bronchial Thermoplasty Procedure

Asthmatx, Inc., a medical device company that has developed a catheter-based procedure for the treatment for asthma, today announced that the first US patient in its FDA approved IDE study has completed all treatment sessions at Henry Ford Hospital in Detroit, MI. The Asthma Intervention Research 2 (AIR2) Trial is investigating the safety and effectiveness of the first-ever procedure to treat the symptoms of asthma. With medication as the current standard of care for asthma, this minimally invasive procedure has the potential to change the course of care for millions of patients with asthma.

Bronchial Thermoplasty(TM), an out-patient investigative procedure, uses the Alair System(R) from Asthmatx to deliver thermal energy to the airway walls to reduce the presence of airway smooth muscle, the tissue responsible for airway constriction and breathing difficulties in asthma patients.

The procedure is performed through a standard flexible bronchoscope that is introduced through a patient's nose or mouth, and into their lungs. The small diameter Alair catheter is delivered into the airways through the working channel of this flexible bronchoscope. The tip of the 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 muscles within the airway wall that narrow the airways in patients with asthma. Although still under clinical investigation, early patient data from three earlier clinical studies suggest that reducing the amount of airway smooth muscle may reduce the ability of treated airways to constrict or narrow. The procedure, like many other flexible endoscopy procedures, is done under light anesthesia, and the patient returns home the same day.

"In an area where medication is the only option, and is sometimes not effective, this research is quite exciting. We were thrilled to treat the first US patient in this study," states Michael Simoff, M.D., an interventional pulmonologist at Henry Ford Hospital and a principal investigator of the AIR2 Trial. "The smooth muscle in your airway serves no known positive purpose, but in asthma patients it can constrict, tighten, and narrow the airway considerably. We are hopeful that reducing this muscle will reduce asthma symptoms and improve quality of life for asthma sufferers."

Asthma is one of the most common and costly diseases in the world. The prevalence of asthma is on the rise, and there is no 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 substantial healthcare resources. In the US each year, asthma attacks result in approximately 10 million unscheduled doctor office visits, 2 million emergency rooms visits, 500,000 hospitalizations, and 5,000 deaths.

"After eight years of careful pre-clinical and clinical research of the Alair System around the world, we are very pleased to be underway with the AIR2 Trial in the United States." says Glen French, CEO of Asthmatx, Inc. "This extraordinary trial already includes 20 of the most prestigious US asthma research centers, making participation in the study available to asthma sufferers from coast to coast."

Approximately 300 patients will be enrolled worldwide in the study during the coming year. Currently, more than 100 patients have already entered the pre-treatment baseline period or have started their treatment course. The procedure is completed in three bronchoscopic sessions, each lasting less than one hour, and each spaced apart by about three weeks.

Researchers are careful to point out that there is no expectation that this new investigational procedure will cure asthma. However, it is hoped that the procedure will prove useful in reducing the severity and frequency of asthma symptoms, and improve the quality of life of patients with asthma.

If you have asthma, are between 18 and 65 years of age, are a non-smoker, and take medication daily to control your asthma, you may be eligible to participate in this study. For more information on participation, please call the following toll-free number: (866) 400-AIR2 or visit www.AIR2Trial.com.

NOTE: Alair System is an Investigational Device. It is limited by United States law to investigational use. To be used by Qualified Investigators only.

Editor's Notes:

For more information on Asthmatx or the Alair System, please contact Karen Passafaro at 650-810-1118 or kpassafaro@asthmatx.com.

About Asthmatx:

Asthmatx is developing catheter-based medical devices for the treatment of asthma, a disease that affects over 20 million people in the United States. Asthmatx has developed the Alair(R) System to perform an investigational outpatient procedure called Bronchial Thermoplasty(TM). 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. The early results of three clinical studies of the Alair System suggest the procedure may offer significant benefits to patients with asthma.

Source: Business Wire

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