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.
SFDA approval for NIOX MINO in China. National code in China for reimbursement of exhaled NO.
NIOX MINO started to be sold for research use in Japan.
Primary care settings approached in selected markets
New version of NIOX MINO introduced.
First health economy studie is published for NIOX MINO. Savings can be accomplished by measuring exhaled NO.
2009. Over 1,000,000 tests sold.
First major US insurance company introduces the method into its policy and reimburses patients for this treatment method
Aerocrine and Panasonic Shikoku Electronics Co., Ltd (PSEC) sign a long-term deal for developing, manufacturing and marketing new generations of products for measuring airway inflammation using exhaled nitric oxide (NO).
Successful defence of the company’s patents.
Extended market presence with partners in Taiwan, South Korea, Brazil and India.
British health economic study published that evaluated the effect of exhaled NO as a routine method when treating asthmatics.
NIOX MINO approved in Canada for use in treating asthma.
2010. The new generation NIOX MINO was successfully launched in Europe and the US.
The cooperation with Panasonic to develop the next generation of products for both clinical and home use by patients is progressing
Commercial assets of Apieron Inc, were aquired.
A group of prominent physicians and researchers, all leaders in the treatment of asthma in the US, issued a consensus publication recommending that the testing for inflammation by means of exhaled nitric oxide be routinely included in the clinical treatment of asthma alongside conventional methods. The recommendations were developed in a closed session at National Jewish in Denver, Colorado, the US’ highest-ranking hospital for the treatment of respiratory diseases. This represents a further step towards the method becoming generally accepted and receiving broader remuneration.
Novo A/S enters as a major share holder in the company.
Successful defence of the company’s patents.