At the prestigious Karolinska Institute in Stockholm, two researchers discover that nitric oxide (NO) can be used as a marker of airways inflammation.
1997. Aerocrine AB is set up to exploit the clinical potential of exhaled NO.
1998. Louis Ignarro, a member of the Aerocrine Scientific Advisory Board, shares the Nobel Prize for work on NO as a signalling molecule.
1999. Aerocrine’s first NO device receives CE certification for medical use. The American Thoracic Society (ATS) and European Respiratory Society (ERS) publish recommendations for measurement of NO.
2000. The NIOX® device is CE certified, and the first three systems are sold. Aerocrine signs its first distribution agreement.
2001. NIOX is launched in Europe, and development work begins on the NIOX MINO®.
2002. The NIOX distribution network expands, and a subsidiary, Aerocrine Inc, is established in the US. A network of NIH (National Institutes of Health) sponsored clinics in the US order NIOX devices [for research use].
2003. NIOX receives market authorization in the US through the FDA (Food and Drug Adminstration) 510(k) process. A licensing agreement is set up with Ionics Business Group. Aerocrine Ltd is set up in the UK. The first NIOX clinical study is published. NO measurement features in Dutch guidelines for childhood asthma.
2004. NIOX MINO receives CE certification, and NIOX receives marketing approval in Canada. Sales of NIOX MINO begin in Germany, and a licensing agreement is signed in Switzerland [with Eco Medics AG].
2005. NIOX MINO is launched in selected European markets. Aerocrine GmbH is set up in Germany. A clinical study in the prestigious New England Journal of Medicine confirms that routine measurement of NO with NIOX can half drug consumption without compromising clinical efficacy.
2006. A paper from US clinics using NIOX devices, demonstrates the value of exhaled NO measurements in monitoring and treating asthma. The journal Thorax publishes a guide to the interpretation of NO measurements, to assist in treatment and diagnosis of asthma patients.
2007. US physicians are reimbursed for exhaled NO tests. Aerocrine is listed on the Stockholm Stock Exchange, conducts a SEK 225m share issue, and appoints a new CEO, Paul de Potocki. NIOX® Flex, the successor to NIOX, is unveiled at the ATS congress. An FDA application is filed for NIOX MINO. Distribution agreements are signed in France and China, and a new service centre is opened in Uppsala. NO measurement features in new US guidelines and in Swedish recommendations.
2008. NIOX MINO receives market authorization for the US 510(k) clearance.