SOLNA, Sweden
Regulatory News:
Aerocrine AB (STO:AERO-B), a leader in products to monitor and manage airway inflammation associated with Asthma, announced today that its handheld airway inflammation monitoring device, NIOX MINO®, has been re-registered for marketing and sales by the China Food and Drug Administration (CFDA). The approval means that Aerocrine and its partners can now resume its sales and marketing activities of NIOX MINO and grow the deployed base in the Chinese market.
“The approval is very welcome both for us and for patients with asthma. The advantages of FeNO (Fractional exhaled Nitric Oxide) testing are well-recognized and together with key opinion leaders for asthma we will spread the knowledge of FeNO throughout China. In order to help more patients, we will work to expand the installed base and continue to promote the test kit utilization at hospitals. The approval also gives reassurance to our distributors to actively engage with customers again”, said Scott Myers, CEO, Aerocrine.
The re-registration approval is effective today and means that Aerocrine and its distributors can immediately reassume sales and marketing of the NIOX MINO in China. FeNO tests have been approved for PPT (pay-per-test) in 15 of the 32 provinces, which means that the doctors are allowed to charge patients for the tests. In addition there are currently three regions; i.e. Shanghai City, Tianjin City, and Guangdong province, that have received reimbursement. Submissions for reimbursement approvals have also been made in other regions.
About Aerocrine
Aerocrine AB is a medical products 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®. 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, Switzerland and the U.K. Aerocrine shares were listed on the Stockholm Stock Exchange in 2007.
About asthma
Asthma is a chronic inflammatory disease of the airways characterized by symptoms including cough, wheezing and difficulty in breathing. Asthma is one of this world’s most common and costly diseases, affecting 8-10 % of the world population and always in the top five in terms of costs of chronic diseases. Since the disease has no cure, proper diagnosis and management are important to optimize the treatment of a patient’s asthma. Using an Aerocrine FeNO-testing device offers several advantages for patient care, including improving patient safety by helping them to maintain adequate control and minimize exacerbations.
Aerocrine may be required to disclose the information provided herein pursuant to the Securities Markets Act and/or the Financial Instruments Trading Act. The information was submitted for publication at 08:00 am on December 15, 2014.
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CONTACT
Aerocrine AB
Scott Myers
Chief Executive Officer
+46 768
788 379, +1 970 368 0336
