The New NIOX MINO Asthma Inflammation Monitor. From the company that is revolutionizing the way asthma is managed

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The New NIOX MINO Asthma Inflammation Monitor From the company that is revolutionizing the way asthma is managed

NIOX MINO the market leader in Asthma Inflammation Monitoring with more than 1 million successful tests performed Now it s even more useful in your clinic Since NIOX MINO was introduced it has been an absolute success. To date more than 1 million tests have been successfully completed and the performance is well documented in more than 20 clinical papers in peer reviewed journals making NIOX MINO a true market leader in monitoring airway inflammation. Aerocrine has paid attention to the useful suggestions and feedback from users and has continuously improved NIOX MINO. Now the differences can be seen on the outside too. Now available NIOX MINO Data Manager For more efficient management of patient data in the clinic Aerocrine has developed a new software NIOX MINO Data Manager. NIOX MINO uses IR communication for easy transfer of patient data to a PC. Historical patient data can be followed over time and presented graphically. Aerocrine represents an impressive knowledge and competence within asthma inflammation measurement and is revolutionizing the way asthma inflammation is managed. With the new version of NIOX MINO we have taken another leap forward. Nitric oxide (NO) is produced in the epithelial cells of the bronchial wall as part of the inflammatory process. NO production increases when there is an eosinophilic airway inflammation. The presence of endogenous NO in exhaled air was first reported in 1991 by Gustafsson et al. and in 1993 Alving et al. found that NO in exhaled air was elevated in patients with asthma. These researchers are among the founders of the company Aerocrine. There has been a continuous flow of research and a large body of data (>1,500 publications in peer reviewed medical journals) to confirm the clinical value of exhaled NO measurement.

NIOX MINO the asthma inflammation monitor for proactive inflammation control Asthma is defined as a chronic inflammatory process, which leads to airflow limitation and increased responsiveness to asthma triggers. Until now, routine assessment of the level of inflammation has not been possible. Controlling the inflammation, rather than its consequences, can dramatically improve the treatment and care of your asthma patients. Relying on the patient s history, subjective evaluation of current condition and measuring the lung function is reactive symptom control. Be proactive measure what really matters the inflammation status. This means that you can detect a deterioration in the patients asthma before it causes problems. NIOX MINO allows personalized asthma care Inflammation measurement with NIOX MINO offers a personalized asthma care that can dramatically improve the treatment and care of your patients. It takes less than 2 minutes to get a value of the inflammation. With the results in your hand, while you still have the patients in your clinic, you and your patients get an im mediate feedback on the inflammatory status. The patient s understanding of the disease improves and results in better compliance. The NIOX Value the new Gold Standard in Inflammation Monitoring The value you get from NIOX MINO, The NIOX Value, is always quality assured. Various factors can influence the measurement of the patient s inflammation. An accurate and reliable NO value is vitally important for both the physician and the patient. The NIOX Value together with other diagnostic parameters will be the basis for important decisions concerning the patient s asthma management program. NIOX MINO has a built-in, highly sensitive quality assurance system that will always guarantee an exact and accurate measurement that can be reliable upon The NIOX Value. The NIOX Value improves diagnostic accuracy 1, 2 A high NIOX Value predicts steroid response 3 The NIOX Value determines the best treatment for chronic cough 4 Both low and high NIOX Values are of clinical significance 5 It improves the patient s understanding and improves compliance 6, 7 It is cost effective 8 9, 10 It optimizes dose-adjustments It predicts asthma relapse 11 Historical patient data can be followed over time and be presented graphically using the new software NIOX MINO Data Manager.

NIOX MINO convenient for you and your patients to use Accurate results NIOX MINO with its pre-calibrated NO sensor gives a NIOX Value that is immediate, accurate, reproducible and quality assured. 12 25 Infection control A disposable bacterial and viral filter prevents contamination of the device and between patients. Easy fingertip navigation The new NIOX MINO has an improved touch-screen for quick and easy navigation and gives a better display of results. Dynamic flow control The built-in flow regulator makes it easy even for young children to keep a constant flow rate during the ex halation. Quality assured An automatic surveillance procedure is checking for malfunction of the device and the NO sensor. Inhalation of NO-free air NIOX MINO removes ambient NO, which ensures accuracy and follows the recommendations by ATS/ERS. 26 Demo mode Shows the procedure in order to give the patient an under standing of how the test is made. Data storage Test Cards (smart cards) for convenient patient data storage. Data transfer to a PC... NIOX MINO uses IR communication for easy transfer of patient data to a PC using the new software NIOX MINO Data Manager. Historical patient data can be followed over time and patient data can be presented graphically. The software also makes it possible to create patient reports that can be printed or stored as pdf-files. Measurement data can be further exported for statistical analysis....or to a printer The patient data can also be transferred to a printer via the IR port. Additional features No calibration or maintenance Suitable both for adults and children Can be used in the clinic or at home Follow the ATS/ERS recommendations 26 CE marked for clinical use 510(k) cleared by FDA NIOX MINO Sensor Pre-calibrated disposable sensor for 100 or 300 measurements. Touch-screen for quick and easy navigation and display of results. Test Cards make it possible to store individual patient data over time.

Procedure NIOX MINO make your practice a center of excellence NIOX MINO provides immediate measurement of the inflam mation status. This quick, easy and non-invasive tool can make your practice a center of excellence in the management of asthma. 1 Extensive clinical publications 12 25 Award-winning ergonomic design 27 28 Support from the company with the longest experience of inflammation measurement and the market leader Ask Aerocrine you get help from the world s most eminent clinical experts As a valued user of NIOX MINO, Aerocrine will make every effort to support you and answer your questions. Empty lungs 2 If you need help interpreting The NIOX Value ask Aerocrine. We are in touch with the world s most eminent clinical experts and always aim to provide you with the latest information regarding the clinical use of inflammation measurement. Inhale deeply through disposable filter 3 Exhale through filter Disposable single session bacterial and viral filter prevents contamination. Filtering of inhaled air eliminates contamination from elevated ambient NO levels. View results on screen The procedure can be followed by either the audio or visual feed-back. Procedure and measurement results are available within a couple of minutes.

Aerocrine is revolutionizing the way that asthma is managed 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 Flex and NIOX MINO. 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. The founders of Aerocrine emerged from the highly prestigious Karolinska Institute in Sweden where they were the first to identify Nitric Oxide (NO) as a marker of airway inflammation. Aerocrine has taken this significant discovery from laboratory to listed company and is now established in some of the world s largest markets. Over 1 million tests have been successfully performed with NIOX MINO. 0413 510(k) K072816 NIOX MINO is CE-marked according to Medical Device Directive MDD93/42/EEC and 510(k) cleared by FDA. US Patent 5,447,165, US Patent 5,922,610, US Patent 6,038,913, US Patent 6,063,027, US Patent 6,099,480, US Patent 6,149,606, US Patent 6,183,416, US Patent 6,511,425, US Patent 6,626,844, US Patent 6,723,056, US Patent 6,733,463, US Patent 6,761,185, US Patent 7,014,692, US Patent 7,270,638, US Patent D448,693, US Patent D457,231, US Patent D492,035, US Patent D496,667 and patents pending. NIOX MINO, NIOX and Aerocrine are registered trademarks of Aerocrine AB. A new dimension in asthma care DESIGNED BY AEROCRINE SWEDEN www.nioxmino.com, www.aerocrine.com Aerocrine AB, P.O. Box 1024, SE-171 21 Solna, Sweden Phone: +46 8 629 07 80, Fax: +46 8 629 07 81, E-mail: info@aerocrine.com Ref: 1. Smith AD, Cowan JO, Filsell S, McLachlan C, Monti-Sheehan G, Jackson P, Taylor DR. Diagnosing asthma Comparisons between exhaled nitric oxide measurements and conventional tests. Am J Respir Crit Care Med 2004;169:473-8. 2. Malmberg LP, Pelkonen AS, Haahtela T, Turpeinen M. Exhaled nitric oxide rather than lung function distinguishes preschool children with probable asthma. Thorax 2003;58:494-9. 3. Smith AD, Cowan JO, Brassett KP, Filsell S, McLachlan C, Monti-Sheehan G, Herbison GP, Taylor DR. Exhaled nitric oxide: a predictor of steroid response. Am J Respir Crit Care Med 2005;172:453-9. 4. Hahn PY, Morgenthaler TI, Lim, KG. Use of Exhaled Nitric Oxide in Predicting Response to Inhaled Corticosteroids for Chronic Cough. Mayo Clin Proc. 2007;82(11):1350-1355. 5. Hewitt RS, Modrich CM, Medlicott T, Cowan JO, Taylor DR. Supporting the diagnosis of non-specific respiratory symptoms in primary care: the role of exhaled nitric oxide measurement and spirometry. Prim Care Respir J. 2008;17(2):97-103. 6. Beck-Ripp J, Griese M, Arenz S, Koring C, Pasqualoni B, Bufler P. Changes of exhaled nitric oxide during steroid treatment of childhood asthma. Eur Respir J 2002;19:1015-9. 7. Delgado-Corcoran C, Kissoon N, Murphy SP, Duckworth LJ. Exhaled nitric oxide reflects asthma severity and asthma control. Pediatr Crit Care Med 2004 5(1):48-52. 8. Berg J, Lindgren P. Economic evaluation of FENO measurement in diagnosis and 1-year management of asthma in Germany. Respir Med. 2008;102(2):219-31. 9. Smith AD, Cowan JO, Brassett KP, Herbison GP, Taylor DR. Use of Exhaled Nitric Oxide Measurements to Guide Treatment in Chronic Asthma. N Engl J Med 2005;352:2163-73. 10. Pijnenburg MW, Bakker EM, Hop WC, De Jongste JC. Titrating steroids on exhaled nitric oxide in asthmatic children: a randomized controlled trial. Am J Respir Crit Care Med 2005;172:831-6. 11. Pijnenburg MW, Hofhuis W, Hop WC, De Jongste JC. Exhaled nitric oxide predicts asthma relapse in children with clinical asthma remission. Thorax 2005;60:215-8. 12. Hemmingsson T, Linnarsson D, Gambert R. Novel Hand-held device for exhaled nitric oxide analysis in research and clinical applications. J Clin Moni Comput 2004;18:379-87. 13. Sovijärvi A, Järvinen H, Uusi-Simola J, Nikkinen P, Piirilä P. Accuracy and repeatability of a hand-held nitric oxide analyzer in adults with respiratory symptoms. ERS Annual Congress, Copenhagen 2005, Poster 3670. 14. Alving K, Jansson C, Nordvall L. Performance of a new hand-held device for exhaled nitric oxide measurement in adults and children. Respir Res 2006;7:67. 15. Gill M, Graff GR, Adler AJ, Dweik RA. Validation study of fractional exhaled nitric oxide measurements using a handheld monitoring device. J Asthma. 2006;43(10):731-4. 16. Martins P, Caires I, Torres S, Borrego C, Neupath N. Reproducibility of eno measurements in children using a hand-held analyser. Eur Respir J 2006; 28, suppl 50: Poster 4528. 17. McGill C, Malik G, Turner S. Validation of a hand-held exhaled nitric oxide analyzer for use in children. Pediatr Pulmonol. 2006 Nov;41(11):1053-7. 18. Pijnenburg MW, Floor SE, Hop WC, De Jongste JC. Daily ambulatory exhaled nitric oxide measurements in asthma. Pediatr Allergy Immunol. 2006;17(3):189-93. 19. Chen W, Purohit A, Barnig C, Casset A, de Blay F. Niox and Niox Mino: comparison of exhaled NO in grass pollen allergic adult volunteers. Allergy. 2007;62(5):571-2. 20. Khalili B, Boggs PB, Bahna SL. Reliability of a new hand-held device for the measurement of exhaled nitric oxide. Allergy 2007;62:1171-1174. 21. Menzies D, Nair A, Lipworth BJ. Portable exhaled nitric oxide measurement: Comparison with the gold standard technique. Chest 2007;131(2):410-4. 22. Sardón Prado O, Aldasoro Ruiz A, Korta Murua J, Mintegui Aramburu J, Emparanza Knorr JI, Pérez-Yarza EG. Agreement between two devices for measuring exhaled nitric oxide. An Pediatr (Barc). 2007;67(6):572-7. 23. Kostikas K, Papaioannou AI, Tanou K, Koutsokera A, Papala M, Gourgoulianis KI. Portable exhaled nitric oxide as a screening tool for asthma in young adults during pollen season. Chest. 2008 Apr;133(4):906-13. 24. Sardón Prado O, Pérez-Yarza EG, Aldasoro Ruiz A, Korta Murua J, Mintegui Aranburu J, Emparanza Knörr JI. Fractional exhaled nitric oxide: Validation of a 6 second exhalation time with two different analysers. An Pediatr (Barc). 2008;69(3):221-6. 25. Torre O, Olivieri D, Barnes PJ, Kharitonov SA. Feasibility and interpretation of FE(NO) measurements in asthma patients in general practice. Respir Med. 2008;102(10):1417-24. 26. ATS/ERS Recommendations for Standardized Procedures for the Online and Offline Measurement of Exhaled Lower Respiratory Nitric Oxide and Nasal Nitric Oxide, 2005. Am J Respir Crit Care 2005;171:912-30. 27. Medical Design Excellence Award 2005. 28. Industrial Excellence Awards 2005. EMD 000083-04 September 2008