Outpatient Procedure for Asthma; Asthmatx Announces the Start of its FDA Approved IDE Study that may Change the Course of Asthma Care

Business Wire, Jan 9, 2006

MOUNTAIN VIEW, Calif. -- Asthmatx, Inc. today announced the start of its Asthma Intervention Research 2 (AIR2) Trial of its catheter-based investigational procedure that may change the standard of care for millions of asthma sufferers.

Asthma is one of the most common and costly diseases in the world. It affects more than 20 million people just in the U.S.; with an estimated 2 million emergency room visits, and 6,000 deaths per year. The prevalence of asthma is on the rise, and there is no cure.

Asthma is a disease involving greater than normal responsiveness of airways in the lungs to a variety of stimuli. This increased responsiveness can take the form of swelling of the airway wall, excess mucus production that can clog the airways, and significant narrowing of the airways when muscles in the airway wall, called "airway smooth muscle", contract.

Most patients with asthma are treated effectively with one or more drugs. Unfortunately, despite an array of generally effective medications, there are still millions of patients who either do not respond adequately to drugs, or simply choose not to take their medications.

Asthmatx has developed a catheter-based investigational procedure known as Bronchial Thermoplasty(TM) for the treatment of asthma. 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(R) catheter is delivered into the airways through the working channel of the flexible bronchoscope. The tip of the Alair catheter is expanded to contact the walls of targeted airways. Thermal energy is then delivered to the airway walls in an effort to reduce the presence of airway smooth muscle within the airway wall, and thereby reduce the ability of treated airways to constrict. The procedure, like many other flexible endoscopy procedures, is done under light anesthesia, and the patient returns home the same day.

"Airway smooth muscle, like the appendix, is believed to have no beneficial function, and yet can be the source of serious medical problems," states Alan R. Leff, M.D, a consultant to Asthmatx during the development of the Alair System and Professor of Medicine, The University of Chicago, Conference Chairman, Biology of Airway Smooth Muscle, and Editor emeritus of the American Journal of Respiratory and Critical Care Medicine. "Reduction of airway smooth muscle with Bronchial Thermoplasty is comparable to reduction in smooth muscle tone with bronchodilators, but is longer lasting, and potentially permanent. Thus, it has been hypothesized that reducing the presence of airway smooth muscle may yield substantial clinical benefit to patients with persistent asthma."

Asthma experts, at medical centers around the world, will participate in the AIR2 Trial to establish the safety and efficacy of the Alair System. Approximately 300 patients will be enrolled in the study during the coming year. The procedure is completed in three treatment sessions, each lasting less than one hour, and each spaced apart by about three weeks.

"We have participated in each of the prior four clinical studies of the Alair System, and treated our first patient five years ago. Our experience suggests that the Bronchial Thermoplasty procedure is quite well-tolerated, and that it may hold considerable promise for patients with severe asthma," says Gerard Cox, M.B., Professor of Medicine, McMaster University, Canada, Past President of the Canadian Thoracic Society, and a Principal Investigator in the AIR2 Trial.

Researchers are careful to point out that this new investigational procedure is not expected to 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.

"After eight years of careful pre-clinical and clinical research of the Alair System, we are very pleased to commence this important FDA approved IDE pivotal clinical study in collaboration with many of the world's foremost experts in the study and treatment of asthma." says Glen French, CEO of Asthmatx, Inc.

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:

To schedule an interview with Dr. Leff or Dr. Cox, or 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 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 results of three clinical studies of the Alair System suggest the procedure may offer significant benefits to patients with severe asthma.