SOLNA, Sweden
Regulatory News:
Aerocrine AB (STO:AERO-B) announces today that Japanese health authorities have approved the use of its FeNO-measuring device NIOX MINO® as a tool for assessing patients with airway inflammation such as asthma.
On November 19, the Japanese Pharmaceuticals and Medical Devices Agency’s (PMDA) granted Aerocrine regulatory approval for the 2009 version of its NIOX MINO. This opens up for marketing and sales of Aerocrine’s FeNO (fractional exhaled nitric oxide)-measuring device in Japan and also means that Japanese physicians can now receive reimbursement for FeNO tests.
”The PMDA’s approval is another milestone for Aerocrine because NIOX MINO is now the only approved FeNO-measuring device in Japan and it provides substantial clinical and quality assurance information for the users,” says Tobias Bergenblad, Asian Commercial Director at Aerocrine. Asthma is a fast growing health care problem, which is caused by a chronic inflammation in the airways. There are about 3 million asthmatics in Japan, of whom 37% have moderate to severe asthma. Between 100 and 150 million people around the globe suffer from asthma and the number is rising. World-wide, asthma-related deaths have reached over 180,000 annually, according to statistics from the World Health Organization.
“As a partner and exclusive distributor for Aerocrine in Japan, we are very happy to finally obtain approval for the first FeNO-measuring device,” says Hideaki Hoki, president of Chest M.I. “There is noticeable anticipation for FeNO-testing in Japan, from pulmonologists, allergologists and patients alike.”
On March 28 this year, PMDA approved the previous 2008 version of NIOX MINO, but sales could not increase as the older version of the device had already been discontinued from Aerocrine’s product portfolio. The now approved 2009 version of NIOX MINO is already in stock and ready for sales through Aerocrine’s Japanese partner and exclusive distributor Chest M.I.
Aerocrine’s NIOX MINO measures fractional exhaled nitric oxide (FeNO)-levels, which are higher in people with asthma than in other people. It was Aerocrine’s founders who first discovered the link between FeNO and asthma caused by airway inflammation. Today, Aerocrine is the world leader in FeNO measurement and the only device manufacturer with a global presence and FDA clearance for devices to be used for clinical practice.
About Aerocrine
Aerocrine AB is a medical products company focused on improved management and care of patients with inflammatory airway diseases such as Asthma. Within this sector, Aerocrine is the world leader. Aerocrine markets NIOX MINO® which enables fast and reliable point-of-care measurement of airway inflammation. This product plays a critical role in more effective diagnosis, treatment and follow-up of patients affected with inflammatory airway diseases. Aerocrine is based in Sweden with subsidiaries in the US, Germany, Switzerland and the UK. Aerocrine shares have been listed on the Stockholm Stock Exchange since 2007 (AERO-B.ST). For more information please visit www.aerocrine.com and www.niox.com.
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 November 25, 2013.
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CONTACT
Aerocrine AB
Scott Myers
Chief Executive Officer
Phone:
+46 768 788 379, +1 970-368-0336
