FDA Grants Market Clearance to Aerocrine Inc.’s NIOX MINO®: a New Hand-Held Device to Measure Airway Inflammation in Asthma
Mar 4, 2008
NIOX MINO® Set to Dramatically Improve Airway Inflammatory Disease Management through Personalized Inflammation Control.
NEW PROVIDENCE, N.J., March 4, 2008 – Aerocrine, Inc. today announced that NIOX MINO, a hand-held point-of-care device for the measurement of airway inflammation, has been 510(k) cleared by the U.S. Food and Drug Administration (FDA). Physicians in the U.S. now have a highly accurate, non-invasive and convenient technology that is appropriate for use in a doctor’s office, ultimately helping them improve how they treat asthma patients.
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, M.D., Clinical Professor of Pediatrics 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 ‘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®, NIOX® 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 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.”
AANMA is a non-profit health organization that builds understanding, provides practical assistance and helps families breathe easier through education, advocacy and outreach. For more information about AANMA, visit www.breatherville.org.
Asthma is a chronic inflammatory process that leads to airflow limitation and increased sensitivity to asthma triggers. More than 22 million people in the United States are currently affected by asthma. It is one of the most common chronic diseases of childhood, affecting more than six million children.
Asthma has far-reaching social and economic impacts. The annual cost of this disease is estimated to be nearly $18 billion through direct costs of $10 billion, such as hospitalizations, medications and other healthcare costs; and indirect costs of $8 billion, which include lost earnings due to illness, death or absenteeism. In 2002 there were more than 4,000 mortalities due to this chronic condition.
In the U.S.
Paul de Potocki
CEO, Aerocrine AB
+46 8 629 07 82
Aerocrine AB (publ) is a medical technology concern focused on the improved management and care of patients with airway inflammation. The company markets NIOX® Flex globally, and also markets NIOX MINO® – which represents a new generation of hand-held products – in Europe. 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 asthma patients. 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.
Aerocrine discloses the information provided herein pursuant to the Securities Markets Act and/or the Financial Instruments Trading Act. The information was submitted for publication at 7:55 a.m. on March the 4th 2008.