Ons 25 maj / År 40 / Nr 1 2022

Aerocrine’s solution for determining asthma on the verge of a break-through in the US market

Medical technology company Aerocrine, founded by researchers from the Karolinska Institute in Stockholm, has taken a large step towards a break-through on the US market. Aerocrine has developed two reliable products that via tests monitor the levels of exhaled nitric oxide (NO) and are used to determine inflammatory airway diseases. As The American Thoracic Society – ATS guideline on the Interpretation of Exhaled Nitric Oxide for Clinical Applications has now received formal recognition and support from the American College of Allergy, Asthma, and Immunology (ACAAI) and the American Academy of Allergy, Asthma, and Immunology (AAAAI), Aerocrine’s products are now successfully being sold and marketed on the massive US market.

Asthma’s cost burden to society – focusing on USA alone –exceeds 50 billion US dollars on an annual basis. There is no cure for asthma; current therapy is therefore focused on controlling the disease. Aerocrine’s NIOX MINO® FeNO monitor can help physicians identify patients who will be responsive to treatment with anti-inflammatory medications such as inhaled corticosteroids (ICS), as well as target patients who are not adhering to their treatments.
As all of the major US respiratory societies now recognise the importance of FeNO testing in managing asthma, Aerocrine has now been able to focus on the sales and marketing, making it possible to strengthen its position and drive usage of the NIOX MINO® FeNO monitor on the US market.

The challenge in entering the US market
Aerocrine markets one product globally, namely the NIOX MINO®. The product is a highly reliable and effective tool to assist in the diagnosis and control of airway inflammation. The previous device NIOX Flex®, which was developed more for R&D purposes rather than for clinical use, is slowly being withdrawn from the market.
Airway inflammation defines asthma. Due to a previous lack of financial coverage provided to clinicians as well as lack of guidelines, sufficient tests have been something of a rarity in the US. Medical practitioners have primarily based the diagnosis and management of asthma on traditional clinical tools which cannot provide high accuracy in terms of the actual stage of the illness. It has been estimated that around 25 per cent of all patients suffering from asthma have received an inaccurate diagnosis, resulting in the wrong treatment.
American medical practitioners are largely dependent on financial reimbursement from private health insurers. The challenge has been to attract enough interest in order to influence the insurers to cover the costs of appropriate tests to determine airway inflammatory illnesses, such as asthma.
Several private insurance companies wanted all three prominent medical societies in the US to support the method. In September 2011 the ATS (the American Thoracic Society) published their guidelines and in April 2012 a joint statement by ACAAI and AAAAI was made public providing the proof required; namely that clinicians can see the value and want to use the testing solutions provided by Aerocrine.

The value of testing
Nitric oxide (NO) is widely distributed throughout the body and its effects are generally benign and important to cell physiology. However, chronic inflammation can lead to excessive production of NO which can be collected and measured as an indicator of the presence and extent of inflammation.
The confirmation given by the ATS, ACAAI and AAAAI underlines the importance of measuring FeNO to assess airway inflammation in order to determine appropriate treatment for asthma patients. The ATS guideline defines clinical situations where FeNO testing is appropriate as well as guidelines for the interpretation of FeNO results.
“By employing our product solution NIOX MINO®, clinicians are able to make more informed and secure decisions. The ATS guideline has clearly stated that FeNO testing provides valuable information to the physician that traditional clinical tools simply cannot provide”, Michael Colérus, CFO at Aerocrine, underlines.

Asthma – future endemic disease
Aerocrine will continue to develop products to improve the quality of life, management and care of people with airways inflammatory disease. The long-term goal is to provide safe, easy-to-use testing equipment that asthma patients can use at home, just like the monitoring tests available to people suffering from diabetes.
According to experts, asthma is one of the big endemic diseases of the future. The interest is therefore high in developing solutions for controlling the disease, as well as eliminating it as far as possible. As a result, Aerocrine has an on-going collaboration with Panasonic HealthCare to develop the next generation of products for physicians as well as for the home-based future monitors of asthma.