San Francisco, CA, May 23, 2007 -- Asthmatx, Inc., a medical device company that has developed a catheter-based procedure for the treatment of asthma, announced today that positive results from the Research in Severe Asthma (RISA) Trial were reported today at the annual scientific assembly of the American Thoracic Society (ATS) by Neil Thomson, MD, Professor of Respiratory Medicine, University of Glasgow, Glasgow, Scotland. Clinically and statistically significant improvements in pulmonary function, asthma control, and quality of life, as well as a reduction in use of rescue medications, were observed following the bronchial thermoplasty procedure in patients with severe asthma. Bronchial Thermoplasty is an innovative non-drug treatment for asthma under clinical investigation in the United States.
The RISA Trial was conducted at a total of eight hospitals, in three countries, and evaluated the safety and efficacy of bronchial thermoplasty in 32 adult subjects with severe persistent asthma who remained symptomatic despite taking regular asthma medications. Compared to patients who received only standard asthma medications, patients who received the bronchial thermoplasty procedure and standard medications showed clinically and statistically significant improvements in pulmonary function, quality of life, and asthma control, and used less rescue medication nearly 6 months following the procedure. One year following the treatment, 50% of bronchial thermoplasty treated patients were able to wean completely off oral corticosteroids (OCS), compared to 14% of patients who did not receive the treatment. Further, a greater overall reduction in OCS dose was observed at 52 weeks in the bronchial thermoplasty treated patients compared with those that did not receive treatment at 52 weeks, although this difference didn't reach statistical significance. The study was not powered to show statistical significance in medication changes.
In this group of patients with severe asthma, an increase in respiratory-related symptoms, and hospitalizations related to these symptoms, were expected and observed during the period immediately following the procedure. These symptoms were of the type expected following bronchoscopy in patients with asthma, and they resolved on average within seven days.
"Following bronchial thermoplasty, patients with severe, refractory asthma demonstrated significant improvements in pulmonary function and asthma control," states Dr. Thomson. "These significant and seemingly long-lasting improvements came at the cost of a short-term increase in hospitalizations, but the apparent benefits seem to be greater than the manageable consequences of the procedure."
"The results from this randomized, controlled, multi-center trial provide some hope for patients with severe, refractory asthma - people who despite taking state-of-the-art medications are still experiencing the disruptive and distressing symptoms of their asthma," states Glen French, CEO of Asthmatx, Inc. "We were particularly encouraged by the data that suggested that patients may be able to reduce their oral steroid dose and still maintain their asthma control."
Current Research of Bronchial Thermoplasty
If you have asthma, are between 18 and 70 years of age, are a non-smoker, and take medication daily to help control your asthma, you may be eligible to participate in a future bronchial thermoplasty clinical study. For more information on participation, please call the following toll-free number: (866) 400-2472 or visit www.bronchialthermoplasty.com.
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. The Alair System from Asthmatx was recently awarded "Best of 2006" by Popular Science Magazine and Bronchial Thermoplasty was named one of the "Top Ten Medical Innovations for 2007" by the prestigious Cleveland Clinic. 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.