US Expert Panel Recommends the Use of Fractional Exhaled Nitric Oxide (FENO) in the Diagnosis and Management of Asthma

SOLNA, Sweden, Jan. 13 /PRNewswire/ -- Aerocrine AB (OMX Nordic Exchange: AERO) today announced that a group of prominent clinicians and researchers, all leaders in the field of asthma in the US, has issued a consensus paper recommending that inflammation monitoring using exhaled nitric oxide should be part of the routine clinical management of asthma in conjunction with other conventional methods. The points of clinical consensus were arrived at during a closed meeting held at National Jewish Health in Denver, Colorado.

The panel recommends that FENO should be used to determine the presence or absence of eosinophilic airway inflammation, to determine the likelihood of steroid responsiveness, to measure response to steroid therapy and level of inflammation control. In addition, the expert panel concludes that FENO is a useful tool to monitor patient ICS treatment adherence and allergen exposure. Traditional tools used by the clinician do not identify or measure inflammation, the underlying cause of asthma symptoms; hence the FENO value can provide additional valuable information not otherwise apparent to either physician or patient.

The panel also notes that private payer resistance is still common, and some insurance carriers continue to refuse reimbursement for FENO testing on the grounds that it is investigational, experimental or unproven. However, the consensus panel disagrees with this stand, and believes that the data support the use of FENO in asthma management in conjunction with conventional tools.

"FENO gives the clinician insight into the status of airway inflammation that is not obtainable via the history, physical examination and lung function tests commonly considered 'the standard' of assessment," said Peter Boggs, M.D., Allergist at The Asthma-Allergy Clinic & Research Center, Shreveport, LA. "Without it, a physician is simply guessing the effectiveness of anti-inflammatory therapy. We should not have to rely on guesswork to properly help people with asthma."

"Understanding and controlling airway inflammation, the underlying cause of respiratory symptoms and asthma exacerbations, is important for the effective management of asthma," said Neal Jain, M.D., Allergist/Clinical Immunologist at Dean Health System, Madison, Wisconsin. "There is both over-treatment and under-treatment of asthma and this simple test makes it possible to provide asthma patients with the appropriate medication and dosage based on a patient's individual needs."

Aerocrine's founders made the original discovery that nitric oxide in exhaled breath is elevated in patients with asthma. The company has since pioneered the development of medical devices and the method to monitor airway inflammation by measuring FENO. Aerocrine's first device received CE marking in Europe in 2000 and FDA clearance in the US in 2003. NIOX MINO, the first and only handheld device for FENO monitoring in clinical practice, received CE marking in 2004 and FDA clearance in early 2008. To date, more than three million patient tests have been performed around the world using Aerocrine's FENO monitoring systems.

"NIOX MINO provides accurate, reproducible and immediate measurement of FENO, which is a non-invasive, simple and safe method to obtain a quantitative measure of steroid-responsive airway inflammation, that today helps physicians across the world to improve patient outcomes and reduce healthcare costs," said Chip Neff, President of Aerocrine Inc.

Asthma is a chronic inflammatory process that leads to airway limitation and increased sensitivity to asthma triggers. The disease affects more than 22 million Americans, including more than six million children, and a majority is not receiving optimal treatment.

For more information, please visit www.aerocrine.com

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 the 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 US, Germany and the UK. Aerocrine shares were listed on the Stockholm Stock Exchange on 15 June 2007.

About NIOX MINO

NIOX MINO® received 510(K) market clearance from the U.S. Food and Drug Administration (FDA) for clinical use in May 2008.  NIOX MINO is a hand-held device that provides accurate, reproducible, and immediate measurement of exhaled nitric oxide (eNO), a validated method for assessing asthma-related airway inflammation.  

NIOX MINO can be used in the doctor's office to provide a non-invasive assessment of airway inflammation. NIOX MINO is a tool offering people suffering from inflammatory airway disease personalized inflammation control. Its use is reimbursable in the U.S. through CPT code 95012.

For more information about NIOX MINO, and to view a video demonstration of how to use the device, please visit www.nioxmino.com or call (866) 275-6469.

Aerocrine may be required to disclose the information provided herein pursuant to the Securities Markets Act. The information was submitted for publication at 14:15 am on January the 13th 2010.

SOURCE Aerocrine AB