Aerocrine's NIOX MINO receives market approvals in Taiwan, South Korea

Aerocrine AB (OMX Nordic Exchange: AERO) announced that it's product, NIOX MINO®, has received market approvals on the South Korean and Taiwanese markets. An approval is an important step towards receiving reimbursement for inflammation monitoring with the help of FeNO in asthma management.

KFDA, Korea Food & Drug Administration, decided on December 27, 2011 to give NIOX MINO market approval in South Korea. The approval means that Aerocrine now has the possibility to receive reimbursement from public as well as private health insurances on the South Korean market, which in the long term means that sales can start to grow. An application to obtain reimbursement has been submitted.

The decision of the market approval in Taiwan was taken by TFDA, Taiwan Food & Drug Administration, in early January 2012 and an application to obtain reimbursement has been submitted to the Taiwanese authorities. A decision on reimbursement application is expected to be communicated during late 2012.

- All progress on the Asian markets is important as the potential is very high there. Reimbursement in South Korea is totally dependent upon the decision by KFDA and therefore we are happy to have taken another step closer to achieving that. It will however not have any effect on our sales during 2012. Taiwan as such is not a significant market but we are of course glad to have received approval for one additional market, says Morten Gunvad, VP Commercial Operations Europe & Asia in Aerocrine.

Milestone in China

During the autumn 2011 Aerocrine also took one step further towards achieving reimbursement from the public health insurance system on the Chinese market. The Shanghai province (Canton), which is a key province both in regards to size as well as when it comes to embracing news, has decided that health providers can charge patients for the measurement of inflammation with the help of FeNO. This is an important milestone towards getting market access to the entire Chinese market. The decision means that Aerocrine, or FeNO measurement, has approval in seven out of 32 provinces: Henan, Shandong, Liaoning, Jiangsu, Zhejiang, Heilongjiang and Shanghai. The company expects that at least as many provinces will give their approval during 2012. At present CMA (Chinese Medical Association) is conducting a normal values clinical trial with 6 000 participants that is expected to be finalized in the end of 2012, after that Aerocrine expects that an application for national reimbursement can be submitted.