Aerocrine: New Asthma Breath Test Now Ready for Canada.Business Editors/Health/Medical Writers CHICAGO--(BUSINESS WIRE)--April 1, 2004 Aerocrine Inc today announced that NIOX(R), a first-of-a-kind, non-invasive asthma test system, has received market authorization from the Therapeutic Products Directorate Therapeutic Products Directorate (TPD) is a Canadian federal authority that regulates pharmaceutical drugs and medical devices for human use, a role performed by the Food and Drug Administration in the United States. of Health Canada Health Canada (French: Santé Canada) is the department of the government of Canada with responsibility for national public health. Health Canada's goal is to improve Canadian life by improving Canadian longevity, lifestyle and use of public healthcare. . NIOX measures exhaled Nitric Oxide nitric oxide or nitrogen monoxide, a colorless gas formed by the combustion of nitrogen and oxygen as given by the reaction: energy + N2 + O2 → 2NO; m.p. −163.6°C;; b.p. −151.8°C;. , eNO, in human breath - a responsive marker of airway inflammation. Measuring eNO using NIOX is the only simple, non-invasive way to monitor inflammation in asthmatics. With NIOX already cleared by the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. and expanding in US clinics, Canadian patients and medical staff will now be able to routinely monitor asthma in the clinic, without the need for costly invasive procedures. NIOX measures exhaled Nitric Oxide accurately and simply - the patient exhales into a mouthpiece mouthpiece n. old-fashioned slang for one's lawyer. and the NO level is provided instantly. The test allows doctors to more accurately diagnose and prescribe treatment for their patients. NIOX delivers reproducible results and complies fully with the NO measurement guidelines established in 1999 by the American Thoracic Society American Thoracic Society (ATS ), established in 1905, is an independently incorporated, international, educational and scientific society, serving its 18,000 members world-wide who are dedicated in respiratory and critical care medicine. . "We foresee that NIOX will be used extensively in routine clinical practice here in Canada, just as we are beginning to see in the U.S. and Europe", says Trevor Bourke, President of Aerocrine Inc. "Through it's expansion on the clinical market, NIOX presents physicians with a convenient way of working with eNO measurements." Nitric oxide is endogenously produced in the lungs, but when the airways are inflamed, such as in asthmatics, NO concentrations in exhaled air are increased. Research documented in over 900 studies has shown, among other things, that eNO levels of 5 to 20 parts per billion are considered healthy, whereas higher levels indicate an ongoing inflammation in the lungs. Exhaled NO levels correlate with biopsy examinations and respond rapidly to anti-inflammatory treatment. So measuring exhaled NO is an objective method of assessing airway inflammation and the patient's response to anti-inflammatory therapy. NIOX can also be used with an accessory, NIOX(R) NASAL to measure nasal NO. Nasal NO measurements may prove useful in the diagnosis of primary ciliary dyskinesia Primary ciliary dyskinesia (PCD), also known as immotile ciliary syndrome or Kartagener Syndrome (KS), is a rare autosomal recessive genetic disorder caused by a defect in the action of the tiny hairs (cilia) lining the respiratory tract (lower and -a congenital disorder congenital disorder A large group of disorders arising during development that cause abnormality of the human body. Most are due to genetic factors such as inherited or spontaneous mutations, whereas others are caused by environmental influences during pregnancy such as characterized by frequent respiratory infections. Aerocrine is a world-leading medical technology company focusing on research and development in the area of Nitric Oxide as a marker of inflammation in the human body. Aerocrine develops products for the analysis of airway inflammation in respiratory diseases. The company has 9 approved US patents and was founded in 1997 in Sweden. More information at www.aerocrine.com or info.us@aerocrine.com Aerocrine, Inc. 150 N. Michigan Avenue, Suite 1200, Chicago, IL 60601 Phone: 312-781 6240 |
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