A First-of-a-Kind, Non-Invasive Test To Monitor Asthma - NIOX Cleared by the FDA.

Business Editors/Health/Medical Writers

CHICAGO--(BUSINESS WIRE)--May 1, 2003

Aerocrine Inc today announced that NIOX(R), a first-of-a-kind, non-invasive test system, has been cleared by the US Food and Drug Administration (FDA) to measure the concentration of nitric oxide (NO) in exhaled human breath - a responsive marker of airway inflammation in patients with asthma.

Nitric oxide is endogenously produced in the lungs, but when the airways are inflamed, such as occurs in patients with asthma, NO concentrations in exhaled air are increased. Extensive research (more than 800 studies have been published to date) has shown that exhaled NO levels of 5 to 20 parts per billion are considered healthy, whereas higher levels indicate an ongoing inflammation in the lungs. Exhaled NO levels have been shown to correlate with biopsy examinations and respond rapidly to anti-inflammatory treatment. Thus, exhaled NO measurement represents an objective method of assessing airway inflammation and the response to anti-inflammatory therapy. Measurement of exhaled NO with NIOX is now the only simple FDA-cleared, non-invasive way to monitor inflammation in asthma.

"This is going to be a major breakthrough in asthma management", says Dr Phil Silkoff, a prominent researcher in the field from Denver, Co. "With exhaled NO levels, we can measure the effect of treatment on inflammation - the root cause of the disease."

NIOX measures exhaled NO accurately and simply - the patient exhales into a mouthpiece and the NO level is provided instantly. This removes the need to do painful biopsies and difficult sputum tests. Furthermore, NIOX is suitable for use in children from about the age of 4 years.

"Patients and medical staff find NIOX easy to use. It allows us, for the first time, to monitor a patient's asthma and response to anti-inflammatory therapy routinely without the need for unpleasant and costly invasive procedures" continues Dr Philip Silkoff.

NIOX is easy to manage, delivers reproducible results and complies fully with the NO measurement guidelines established in 1999 by the American Thoracic Society.

"We foresee that NIOX will be used extensively in routine clinical practice here in the States", says Trevor Bourke, President of Aerocrine Inc. "Actions have been taken to establish reimbursement and coding."

Aerocrine Inc is a wholly owned subsidiary of Aerocrine AB. Aerocrine AB is a clinically based medical technology company that leads the way in the development of devices for monitoring inflammation through the measurement of gaseous markers. The company was founded in 1997 by scientists from the prestigious Karolinska Institute in Sweden and has its headquarters in Solna, Stockholm. The founders were the first to identify nitric oxide (NO) as a marker of inflammation. Today, this strong scientific heritage is supported by an international network of clinical advisors as well as an experienced and efficient management team, which is bringing innovative ideas into clinical practice. NIOX is CE-marked according to Medical Device Directive MDD 93/42/EEC and approved for clinical use in EEC countries. NIOX test are now being performed routinely at leading clinical centers in more than 20 countries. Aerocrine holds a comprehensive patent portfolio, including eight approved patents in the USA, with patents pending.

Aerocrine Inc. 150 North Michigan Avenue, Suite 1200. Chicago, IL 60601-7594, US Phone [phone], Fax [phone], E-mail [e-mail], www.aerocrine.com.