NEWS 2006
[05/01/2006]
Encouraging Results Reported on New Investigational Asthma Treatment
Outpatient Procedure for Asthma Featured in American Journal of Respiratory and Critical Care Medicine
MOUNTAIN VIEW, Calif.--(BUSINESS WIRE)--May 1, 2006--Asthmatx, Inc., a medical device company that has developed a catheter-based procedure for the treatment for asthma, today announced that the results of its initial clinical study of its investigational outpatient procedure for the treatment of asthma have been published in the May 1st issue of the American Journal of Respiratory and Critical Care Medicine (AJRCCM). In addition, the lead editorial in this edition of the AJRCCM, titled "Hot Stuff" Bronchial Thermoplasty for Asthma, discusses the potential of this procedure as a completely new approach for treating severe asthma.
Bronchial Thermoplasty?, an out-patient investigative procedure, uses the Alairｮ System 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 primary objective of this feasibility study was to evaluate the safety of performing Bronchial Thermoplasty in patients with mild to moderate persistent asthma by examining its impact on lung function and airway responsiveness over two years. The safety data reported in this study indicate that Bronchial Thermoplasty is well tolerated, and the long-term safety assessment at two years showed no deterioration in respiratory health status. Patients reported satisfaction with the procedure and all patients indicated they would definitely or probably undergo the procedure again.
"While the study evaluated the feasibility and safety of Bronchial Thermoplasty, results also revealed significant improvements in peak expiratory flow and symptom-free days. They further demonstrated significant improvement in airway responsiveness, out to two years," states Gerard Cox, M.B., Professor of Medicine, McMaster University, Canada, Past President of the Canadian Thoracic Society, and principal investigator of the study. "These findings are encouraging and provide important direction for the design of further studies to examine how Bronchial Thermoplasty may help asthma patients who do not respond well to current drug therapies."
"The data from this study, suggesting that Bronchial Thermoplasty may elevate the current standard of medical care for certain patients with asthma, are very exciting," states Glen French, CEO of Asthmatx. "We have also completed two larger randomized and controlled studies, both of which are expected to be reported later this year, and we are well underway with our fourth clinical study, an FDA-approved IDE pivotal study, called the AIR2 Trial (http://www.AIR2Trial.com), at more than thirty top-tier medical centers around the world."
Bronchial Thermoplasty is an out-patient procedure that 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, the data from this study suggests 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.
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.
The fourth clinical study of Bronchial Thermoplasty has begun with the AIR2 Trial (http://www.AIR2Trial.com) which will enroll approximately 300 patients worldwide this year. Currently, more than 100 patients have already entered the pre-treatment baseline period or have started their treatment course.
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 pulmonary function and 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 the AIR2 study. For more information on participation, please call the following toll-free number: (866) 400-AIR2 or visit http://www.AIR2Trial.com
NOTE: AlairR 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
Contact
Asthmatx, Inc.
Karen Passafaro, 650-810-1118
kpassafaro@asthmatx.com
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