Aerocrine submits 510(k) filing for NIOX MINO® in the U.S.


Aerocrine submits 510(k) filing for NIOX MINO® in the U.S.

SOLNA - October 2, 2007 - Aerocrine AB (OMX Nordic Exchange: AERO) announced
that it has submitted a 510(k) application for marketing clearance to the U.S.
Food & Drug Administration (FDA) for its NIOX MINO® device.

NIOX MINO® is the world's first hand-held non-invasive device to measure the
concentration of nitric oxide in exhaled human breath (FENO). Nitric oxide is a
marker for airway inflammation originally discovered by Aerocrine's founders.
Today, FENO measurement is acknowledged in the scientific literature to have
clinical relevance for the control of inflammatory airway disorders such as
asthma. Evaluation of FENO measurements may constitute an important part of a
disease management strategy to improve care of patients with inflammatory airway
disorders. 

“We are now looking forward to co-operating with the FDA during its review
process for NIOX MINO®”, says Paul de Potocki, CEO of Aerocrine.


For more information, contact:

Paul de Potocki
CEO
Phone +46 8 629 0782

About Aerocrine
Aerocrine AB is a clinically based medical technology corporation dedicated to
improved asthma management and care. Aerocrine was listed on the Stockholm Stock
Exchange on 15 June, 2007. The company is marketing NIOX® Flex on a worldwide
basis and is also marketing NIOX MINO®, representing a new generation of
hand-held devices, in Europe. Both products are tailored for rapid, non-invasive
control of the inflammatory status in the airways and may play a critical role
for optimized asthma care and disease control. 
Aerocrine is located in Sweden with wholly owned subsidiaries in the US, UK and
Germany.

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