Asthmatx Presents Impact of Bronchial Thermoplasty on Allergy Practices at ACAAI Annual Meeting

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Mon Nov 9, 2009 11:00am EST

Asthmatx Presents Impact of Bronchial Thermoplasty on Allergy Practices at
ACAAI Annual Meeting
Allergists Get Overview of Novel Non-drug Asthma Treatment after FDA Advisory
Panel Finds the Device Approvable with Conditions




SUNNYVALE, Calif., Nov. 9 /PRNewswire/ -- Asthmatx, Inc. presented the results
of a series of studies investigating the effectiveness and safety of bronchial
thermoplasty delivered by the Alair® System, and how this new procedure will
impact allergy practices, this past weekend in a poster at the 2009 Annual
Meeting of the American College of Allergy, Asthma and Immunology (ACAAI), in
Miami Beach, Fla.

The poster, titled "Where Could Bronchial Thermoplasty (BT) Fit Into Your
Allergy Practice?  Lessons Learned from Multiple Bronchial Thermoplasty
Clinical Trials," highlighted the clinical results from three randomized
clinical trials, which investigated bronchial thermoplasty's effectiveness as
a treatment option for patients with severe asthma.

Bronchial thermoplasty is a non-drug procedure developed to treat adults with
severe asthma and is designed to provide improved asthma quality of life and
control that lasts for at least one year. Bronchial thermoplasty delivered by
the Alair System uses thermal energy to reduce the amount of smooth muscle in
the lungs, which is associated with airway constriction in asthma patients. 

"We have now shown in numerous clinical trials that patients whose severe
asthma is uncontrolled by standard medications can now experience clinically
significant improvements in their asthma control and their quality of life
following treatment with the Alair System," said Glen French, CEO of Asthmatx.
"This poster demonstrates that allergists may soon have a new option to
consider for their patients with severe asthma."

The poster noted that, while the risks of bronchial thermoplasty include
transient worsening of asthma, patients on high doses of inhaled
corticosteroids and long-acting bronchodilators with impaired quality of life
experience meaningful improvements in their overall asthma status. The poster
authors concluded that allergists should consider referring appropriate
patients for bronchial thermoplasty when standard medications are not
sufficient to control their severe asthma.

In the period immediately following bronchial thermoplasty, there is an
expected transient increase in the frequency 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 seven 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.

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 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. 

In October 2009, the Anesthesiology and Respiratory Therapy Devices Panel of
the Medical Devices Advisory Committee to the U.S. Food and Drug
Administration (FDA) voted to recommend that the Alair® System, a device
utilized in bronchial thermoplasty for the treatment of severe persistent
asthma in patients 18 years and older, be found approvable with conditions.  

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

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 has
received a CE Mark for use in the European Union. For more information on
Asthmatx visit www.asthmatx.com.

Alair, Asthmatx and the Asthmatx logo are registered trademarks of Asthmatx,
Inc.


SOURCE  Asthmatx, Inc.

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