Aerocrine Receives Australian Approval for Airway Inflammation Monitors

Solna, Sweden-based Aerocrine AB received approval from Australia for its Niox Mino airway inflammation monitor and the Niox Mino test kit. It April, a nine-member council representing the American Academy and American College of Allergy, Asthma and Immunology published a position statement in support of the clinical practice guideline on Aerocrine’s FeNO (Fractional exhaled Nitric Oxide). The approval of Niox Mino is an important step toward the company receiving reimbursement from public and private health insurance programs in Australia for inflammation monitoring with FeNO in asthma management. FeNO measures airway inflammation responsive to inhaled corticosteroid therapy.

The Australian Therapeutic Goods Administration (TGA) decided in early May to grant approval to the Niox products. They will be marketed and sold in Australia by Aerocrine’s distributor Niche Medical (Innervate Pty Ltd). Following the approval, Aerocrine, in cooperation with its distributor, now develops the strategy for obtaining reimbursement from public as well as private health insurance programs on the Australian market. According to the company, these are key factors for the company’s opportunities to grow sales in the future.

“All progress in Australia is important since there is a great potential in that market—but it is important to remember that we have quite a long way to go before sales can take off,” said Morten Gunvad, vice president of Aerocrine commercial operations in Europe and Asia. “From a strategic perspective, the Australian market is very important as Australia has a number of recognized and prominent research groups working with FeNO. The marketing approval enables us to reach out to these groups as well as opens up for strategic sales, which increases the acceptance and awareness of our products and the method.”

Several asthma researchers in Australia are in favor of the FeNO measurement. A study conducted by Peter Gibson and a team of researchers in 2011 showed the importance of FeNO in asthma management. The patient group that continually measured their FeNO had fewer asthma attacks (compared to the control group that did not measure FeNO) and also used less medication. The study was published in the journal Lancet.

Asthma is a growing health problem worldwide, but particularly so in Australia. Only in Australia, nearly one in ten residents, or about 2 million people, suffer from asthma. Even though the prevalence in recent years has been decreasing, the death rates have increased. In 2009, 411 people died as a result of their asthma, a number that has increased by 45 percent from 1997 to 2009. From today’s 300 million asthmatics worldwide the number of asthmatics is estimated to globally increase to 400-450 million in 2025, according to the patient organization European Federation of Allergy and Airway Diseases.

Aerocrine AB is a medical technology company focused on the inflammatory airway diseases sector.