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New hand-held point-of-care device for asthma monitoring receives 510(k) clearance

Aerocrine : 05 March, 2008  (New Product)
Aerocrine’s Niox Mino, a hand-held point-of-care device for the measurement of airway inflammation, has been 510(k) cleared by the US Food and Drug Administration (FDA).
Niox Mino provides accurate, reproducible and immediate measurement of fractional exhaled nitric oxide (FENO), a validated method for assessing asthma-related airway inflammation. Niox Mino is the first hand-held device to measure airway inflammation - an underlying cause of inflammatory airway diseases - helping physicians improve patient outcomes and reduce healthcare expenditures.

' Niox Mino answers the need for a user friendly, non-invasive, accurate, and cost effective tool that enables any physician to monitor the underlying process of asthma-airway inflammation,' said Peter B Boggs, MD, clinical professor of Paediatrics and Medicine, LSU School of Medicine, Shreveport.' What is important about this is that the control of airway inflammation is the key to the successful management of asthma, and this tool makes this possible.'

Millions of people living with asthma, including many children, are not receiving optimal treatment. All patients are different, requiring different treatments and dosages. Therefore, airway inflammatory disease management and control can be significantly improved through 'personalised' 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 USA through CPT code 95012. The CPT code only applies to FDA-cleared devices (currently Niox, Niox Flex and Niox Mino).

'Historically, monitoring inflammatory airway diseases such as asthma focused primarily on measuring symptoms and lung function,' said Aerocrine’s Trevor Bourke,.' 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 favourably 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 founder of Allergy & Asthma Network Mothers of Asthmatics (AANMA). With this simple test, patients and physicians can take a more strategic approach to asthma care with the goal of using less medication to get maximum results.'
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