New ATS Guideline Recommends Measuring Airway Inflammation in Asthma Management – a Major Breakthrough for Aerocrine

Regulatory News:

Aerocrine AB (STO:AERO) today announced that the American Thoracic Society has released an official clinical practice guideline that provides strong recommendations to measure FENO in patients with asthma. FENO is a point-of-care analytical method for trending and management of airway inflammation which has been pioneered by Aerocrine. Asthma is one of the world’s most widespread diseases and affects more than 300 million people, many of whom are children. Every day, 11 people in the U.S. die from asthma.

Asthma is a chronic inflammatory disease of the airways characterized by symptoms including wheezing and difficulty in breathing. Aerocrine pioneered the method to measure FENO, the fraction of nitric oxide in exhaled breath, a marker of the underlying airway inflammation associated with asthma. From a single breath, physicians can obtain information about the individual patient’s type and extent of inflammation within two minutes. This information significantly aids in the correct clinical characterization and choice of appropriate medication, as well as in the ongoing treatment of the patient’s asthma that is aimed at controlling the airway inflammation. The ATS recommends the use of FENO inflammation measurements to:

– Determine the type of airway inflammation underlying the most common form of asthma, as well as to confirm asthma in patients when objective evidence is needed

– Determine whether patients with chronic respiratory symptoms will respond to corticosteroid treatment, the most commonly used anti-inflammatory medicine

– Monitor airway inflammation in patients with asthma and to monitor patients’ adherence to prescribed corticosteroid therapy

The American Thoracic Society is widely recognized as the governing body that establishes the latest standards of care for adult and pediatric respiratory diseases. Publication of the new ATS guideline means that most patients should now receive the course of actions recommended within the guideline and that the recommendations can be adopted as policy in most situations.

"The fact that the ATS now recommends the broad clinical use of inflammation monitoring is, of course, a significant milestone for our company. The U.S. is the world’s largest market, and strong clinical guidelines are an important prerequisite both for a more widespread use of this technology and for a broader reimbursement of the test by health insurance providers. Most importantly, the adoption of this guideline can help the growing number of people living with asthma have a better quality of life,” says Paul de Potocki, CEO of Aerocrine AB.

"The NIOX MINO technology to identify and monitor airway inflammation in a matter of minutes represents a significant breakthrough for all those living with asthma,” said Nancy Sander, president and founder of Allergy & Asthma Network Mothers of Asthmatics. "Asthma is an inflammatory disease with different underlying causes and alternative treatment options. This technology provides a quick and safe way to better understand our options to achieve personalized asthma control. We now look forward to seeing a growing number of health care payers supporting this guideline to the benefit of their customers.”

"Asthma is a disease characterized by varying degrees and types of inflammation affecting the airways. Despite the fact that the underlying cause of asthma is airway inflammation, asthma has historically been diagnosed and assessed based on characteristic symptoms and measures of lung function. This approach may, in fact, lead to the over-diagnosis of asthma, as such symptoms and lung function impairment may also be seen in other conditions,” says Neal Jain, MD, FAAAAI. "Measuring FENO allows us to more directly assess the inflammatory status of the airway and, in doing so, identifies those patients who will or will not respond to corticosteroid therapy.”

"Understanding and controlling airway inflammation, the underlying cause of respiratory symptoms and asthma exacerbations, is basic for the effective management of asthma,” says Peter B. Boggs, MD, FACAAI, FAAAAI, of The Asthma-Allergy Clinic, Shreveport, La. "Its distinct advantage is that it gives the clinician insight into the status of the airway inflammation at the time the patient is being seen. This is not possible using the other traditional tools. Knowing this enables the physician to manage symptoms, function and airway inflammation as an interrelated system—as it should be. Added bonuses of the method include identifying otherwise unsuspected nonadherence to inhaled corticosteroid medications, determining exposure to eosinophilic triggers, and reducing errors of both omission and commission in the dosing of ICS. To paraphrase Neil Armstrong, FENO is ’One giant step … ’ for asthma care."

For more information on ATS and the guideline, please visit www.thoracic.org and http://ajrccm.atsjournals.org.

Important note

NIOX instruments are medical devices regulated in the United States by the US Food and Drug Administration. Complete Labeling for our devices may be found at www.FDA.gov.

This cleared Labeling is the final authority for Indications, Directions for Use, Risks,

Limitations, Performance, and other information.

Please consult our Labeling for any questions you may have. You may also call Aerocrine at 1-866-275-6469.

About Aerocrine

Aerocrine AB is a medical technology company focused on the improved management and care of patients with inflammatory airway diseases. As the pioneer and leader in technology to monitor and manage airway inflammation, Aerocrine markets NIOX MINO® and NIOX Flex®. Both products enable fast and reliable management of airway inflammation and may therefore play a critical role in more effective diagnosis, treatment and follow-up of patients with inflammatory airway diseases such as asthma. Aerocrine is based in Sweden with subsidiaries in the U.S., Germany and the U.K. Aerocrine shares were listed on the Stockholm Stock Exchange in 2007.

Aerocrine may be required to disclose the information provided herein pursuant to the Securities Markets Act. The information was submitted for publication at 8 a.m. CET on Sept. 2, 2011.

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