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FDA Grants Market Clearance to Aerocrine Inc.'s NIOX MINO(R): a New Hand-Held Device to Measure Airway Inflammation in Asthma
Date:3/4/2008

and control can be significantly improved through 'personalized' monitoring of the airway inflammation rather than just symptoms.

Among the benefits of NIOX MINO, physicians will have insights into treatment efficacy and can better predict a patients' response to therapy and the risk of an asthma relapse. Moreover, physicians will be able to identify patient non-compliance with medications, and can adjust the dose of medication based on individual patients' needs. NIOX MINO is reimbursable in the U.S. through CPT code 95012. The CPT code only applies to FDA-cleared devices (currently NIOX(R), NIOX(R) Flex and NIOX MINO).

"Historically, monitoring inflammatory airway diseases such as asthma focused primarily on measuring symptoms and lung function," said Trevor Bourke, Aerocrine, Inc." The availability of NIOX MINO in the United States represents a major advance in asthma management, because for the first time, doctors can measure the underlying inflammation that causes asthma within a few minutes directly in their offices."

NIOX MINO offers real-time delivery of accurate FENO measurement results within minutes. The device has been used extensively in Europe, where more than one million FENO measurements have impacted the lives of people living with asthma. Its innovative design has won numerous accolades, including a 2005 Medical Design Excellence Award -- the premier awards program in the medical technology community -- in the category of In Vitro Diagnostics.

FENO measurements by NIOX MINO compare favorably to other asthma monitoring methods in terms of providing accurate and reliable results. FENO measurement is an earlier metric than spirometry -- a test of the lungs' breathing capacity -- to inflammation changes following allergen exposure, making it a more sensitive marker of the disease.

"NIOX MINO measures something we can't feel until it is raging out of control -- airway inflammation," said Nancy Sander, president and fou
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SOURCE Aerocrine, Inc.
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