New clinical review gives practising physicians’ recommendations for how to use Aerocrine’s FeNO-test in routine clinical practice

Solna (Sweden) – July 2, 2014 – Aerocrine AB (OMX Nordic Exchange: AERO) announces that the result of a clinical evidence review[1], conducted by a group of highly recognized experts was published today in the medical journal Respiratory Medicine. The article outlines a guide for how to interpret the value of Fractional exhaled Nitric Oxide (FeNO) in suspected asthma patients and in the management of asthma patients on anti-inflammatory treatment.

What´s new from previously published FeNO guidelines2 is that for patients with values in the “grey zone”, between 25 to 50 ppb the authors now give clear treatment recommendations, based on newest clinical documentation. With this approach, measurement of airway inflammation becomes central in assisting with an accurate initial diagnosis of asthma and in the ongoing therapy monitoring and management to achieve the most successful outcomes.

An important attribute of FeNO is its ability to potentially predict if a patient will respond to ICS therapy, thus avoiding the need to put patients on ICS therapy unnecessarily with a “see-if-it-works” approach.

This new view on how to interpret the FeNO value will help general practitioners and other asthma treating physicians to optimize therapeutic control – step up and step down of inhaled corticosteroid, according to the amount of airway inflammation present. Several recent publications have shown FeNO-guided management to result in improved asthma symptom control and up to 50% reduction in exacerbation frequency, compared with standard physician based management which is carried out today. 3,4,5 (Syk, Peirsman, Powell)

Moreover FeNO-guided management of patients allows physicians to monitor patient adherence to anti-inflammatory therapy and to predict risk of future exacerbations6 or decline in lung function7.

“After looking at all the existing clinical data we can conclude that FeNO is a direct biomarker of Th2 driven airway inflammation such as asthma. The FeNO value when interpreted in clinical context is an important decision aid for the practising physician, and should be used more often in both secondary and primary care.” says Leif Bjermer, Professor of Allergy and Respiratory Medicine at Lund University in Sweden and one of the authors.

“The conclusions made by this group of 11 distinguished and well-respected experts across 7 countries is in line with the newly announced health technology assessment made by the UK National Institute for Health and Care Excellence (NICE), in which NICE recommends FeNO* testing for many aspects of asthma care. These are important steps for Aerocrine as we continue to establish FeNO as a global standard of care for inflammatory airway diseases,” says David Plotts, VP International Sales & UK General Manager Aerocrine.

The FeNO test and its developers, Aerocrine AB, emerged from the 1998 Nobel Prize in medicine. Aerocrine offers versatile and easy-to-use monitoring devices for FeNO-testing. Aerocrine’s compact hand-held devices for clinical applications are used for routine measurements in both specialist and primary care clinics and can be used to improve the management of allergic airway inflammation, such as asthma.

NIOX VERO® and NIOX MINO® offer added advantages for patient care, including detecting allergic airway inflammation, determining the likelihood of corticosteroid responsiveness, monitoring of airway inflammation to determine the potential need for corticosteroid, and unmasking of otherwise unsuspected non-adherence to corticosteroid therapy. FeNO-testing can also be of help in finding the optimum corticosteroid dosing, which is important to promote patient safety, whilst maintaining adequate control and minimising exacerbations.

The said review, published in the printed edition of Respiratory Medicine, was supported by a grant from Aerocrine.

For more information, contact:

Scott Myers, Chief Executive Officer, Aerocrine AB, +46 768 788 379, +1 970 368 0336

1. Bjermer L, Alving K, Diamant Z, Magnussen H, Pavord I, Piacentini G, Price D, Roche N, Sastre J, Thomas M, Usmani O, Current evidence and future research needs for FeNO measurement in respiratory diseases, Respiratory Medicine (2014), doi: 10.1016/j.rmed.2014.02.005.

2. Dweik RA, Boggs PB, Erzurum SC, et al; An official ATS clinical practice guideline: interpretation of exhaled nitric oxide levels (FeNO) for clinical applications. Am J Respir Crit Care Med. 2011;184:602-615.

3. Powell H, Murphy VE, Taylor DR, et al. Management of asthma in pregnancy guided by measurement of fraction of exhaled nitric oxide: a double-blind, randomised controlled trial. Lancet. 2011;378(9795):983-990.

4. Peirsman E, Carvelli T, Hage P, Hanssens L, Pattyn L, Raes M,

Sauer K, Vermeulen F, Desager K. Exhaled Nitric Oxide in childhood allergic asthma management a randomised controlled trial. Pediatric Pulmonology, 2013.

5. Syk A, Malinovschi A, Johansson G, Unden A, Andreasson A, Lekander M, Alving K. Anti-inflammatory Treatment of

Atopic Asthma Guided by Exhaled Nitric Oxide: A Randomized, Controlled Trial. J Allergy Clin Immunol 2013. 4

6. Gelb AF, Taylor CF, Shinar CM, Gutierrez C, Zamel N. Role of spirometry and exhaled nitric oxide to predict exacerbations in treated asthmatics. Chest 2006;129:1492-9.

7. van Veen I, ten Brinke A, Sterk P, Sont J, Gauw S, Rabe K and Bel E, Exhaled nitric oxide predicts lung function decline in difficult-to-treat asthma Eur Respir J 2008; 32: 344–349

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 VERO® (EU) 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. For more information please visit www.aerocrine.com or www.niox.com.