Aerocrine's Niox Mino gets China re-registration approval

Source：Ringier Medical Release Date：2014-12-16 632

Medical Equipment

The CFDA approval signals the resumption of marketing and sales activities for the handheld airway inflammation monitoring device for asthma patients

AEROCRINE AB’s Niox Mino handheld airway inflammation monitoring device has just been re-registered for marketing and sales by the China Food and Drug Administration (CFDA).

The approval will also allow Aerocrine (STO:AERO-B), a leading supplier of products that monitor and manage airway inflammation associated with asthma, to expand its deployed base in China.

The Fractional exhaled Nitric Oxide (FeNO) tests have been approved for pay-per-test (PPT) in 15 of 32 provinces. Doctors can, therefore, charge patients for the tests.

Three regions, namely Shanghai City, Tianjin City, and Guangdong province, have received reimbursement. Other regions have received reimbursement requests.

According to Aerocrine CEO Scott Myers, “The approval is very welcome both for us and for patients with asthma. The advantages of FeNO testing are well-recognized and together with key opinion leaders for asthma we will spread the knowledge of FeNO throughout China. The approval also gives reassurance to our distributors to actively engage with customers again.”

Mr. Myers said the company will work to expand the installed base and continue promoting the test kit utilization in hospitals to help more patients.

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