Pivotal Data Show Bronchial Thermoplasty Can Improve Quality of Life and Reduce Asthma...

Pivotal Data Show Bronchial Thermoplasty Can Improve Quality of Life and
Reduce Asthma Attacks and Emergency Room Visits for Adults with Severe Asthma

Non-drug Procedure for Asthma Highlighted at ATS 2009

SUNNYVALE, Calif., May 18 /PRNewswire/ -- Results of the Asthma Intervention
Research 2 (AIR2) Trial of the Alair(R) Bronchial Thermoplasty System,
developed by Asthmatx, Inc., were announced today at ATS 2009, the
International Conference of the American Thoracic Society, in San Diego,
Calif. The AIR2 results demonstrated statistically significant improvements in
quality of life measurements, reductions in asthma attacks (severe
exacerbations) and emergency room visits for respiratory symptoms in adults
with severe asthma who underwent bronchial thermoplasty delivered by the Alair
System.

"The reduction in asthma attacks and improvements in quality of life are
consistent with the outcomes from previous trials," said Mario Castro, MD,
Professor of Medicine and Pediatrics at the Washington University School of
Medicine, and a Principal Investigator in the AIR2 Trial. "These outcomes
provide further clinical evidence needed to demonstrate the safety,
effectiveness and long term benefits of bronchial thermoplasty."

The AIR2 Trial was designed to evaluate the safety and effectiveness of
bronchial thermoplasty in adult patients with severe asthma who were
symptomatic, despite being treated with high doses of standard of care
medications (high dose inhaled corticosteroids and long-acting
bronchodilators). The study was a randomized, double-blind, sham-controlled
trial and enrolled 297 patients at 30 sites in 6 countries. 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 the treatment and sham control groups.

Key statistically significant clinical findings of the AIR2 Trial were:
-- Improvement in the average AQLQ score at 6-, 9-, and 12 months over
sham
control
-- 4 out of 5 Alair-treated patients responded with a clinically
significant improvement in AQLQ compared to 64% of sham controls
-- 32% reduction in asthma attacks
-- 84% reduction in emergency room visits for respiratory symptoms
-- 36% reduction in patients reporting episodes of asthma (multiple
symptoms) adverse events
-- 66% reduction in days lost from work/school or other activities due to
respiratory symptoms

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. These events
typically occur within a day of the procedure and resolve on average within 7
days with standard care. In the long term, fewer bronchial thermoplasty
treated patients reported respiratory adverse events and there was a
significant decrease in patients reporting asthma (multiple symptoms) adverse
events in the Alair-treated group compared to the sham control group.

"The results from AIR2, similar to the results from two prior randomized
clinical trials evaluating the Alair System, demonstrate that patients with
severe asthma can experience clinically significant improvements in their
asthma control and their quality of life," said Glen French, CEO of Asthmatx.

The results of this pivotal study have enabled Asthmatx to submit a Premarket
Approval application (PMA) to the FDA for regulatory approval. The FDA granted
the Alair System PMA Expedited Review Status in October 2008, based on its
potential "to treat asthma, a life-threatening/debilitating disease" and
because the "Alair System offers a breakthrough technology which has the
potential to address an unmet clinical need within the asthma population."

"Participation in the AIR2 Trial required an extraordinary level of
involvement from all patients, and we were encouraged by the very high level
of interest from patients who wanted to participate," said Dr. Castro,
Principal Investigator at Washington University, St. Louis, the largest
enrolling site in the U.S. "This high level of patient interest and
involvement in this complex and time-consuming trial reflects the substantial
clinical need that exists for new treatment options in this population of
patients with severe asthma."

About Bronchial Thermoplasty Delivered by the Alair System
Bronchial thermoplasty is a non-drug procedure 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(R) 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 minimally invasive procedure, like many other
flexible endoscopy procedures, is done under light anesthesia, and the patient
returns home the same day.

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.

About Asthmatx
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. The Alair System from
Asthmatx was 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 Foundation. The Alair System has received a
CE Mark for use in the European Union. For more information on Asthmatx visit
www.asthmatx.com.

SOURCE Asthmatx, Inc.

Scott Shadiow of WeissComm Partners, +1-415-946-1093, sshadiow@wcpglobal.com,
for Asthmatx