Insight™ eNO System to Assist Physicians with Patient Asthma Management

It is estimated that about 26 million people in the U.S. suffer from asthma, making it one of the most common diseases. In fact, over 40,000 American people miss school or work due to asthma and 5,000 people go to the emergency room due to an asthma attack every day. One-quarter of all emergency room visits are asthma related and asthma is the most common chronic childhood disease.

In medicine, exhaled nitric oxide (eNO) can be measured in a breath test for asthma or other conditions characterized by airway inflammation. Exhaled NO is a promising biomarker for the diagnosis, follow-up and as a guide to therapy in adults and children with asthma. The breath test has recently become available in many well-equipped hospitals in developed countries. Medically, eNO is used for people with asthma. Patients with asthma have higher eNO levels than other people. Their levels also rise together with other clinical and laboratory parameters of asthma.

The most widely used technique to measure eNO is with a chemical reaction that produces light. The NO in the breath sample reacts with ozone to form nitrogen dioxide in an excited state. When this returns back to its ground state, it emits light in quantities that are proportional to the amount of exhaled NO. Prior to the availability to measure eNO, assessing and managing airway inflammation was, for all practical purposes, little more than a guess! The ability to measure eNO in the physician's office is "one giant step" in the care of adults and children with asthma.

The Insight eNO system by Apieron measures exhaled nitric oxide (eNO), which is a well-established indicator of airway inflammation and asthma control. The Insight system is a highly accurate device, expressly designed for the physician’s office. It is non-invasive, safe, easy to use, and provides results in less than a minute. Apieron’s unique biosensor detects trace amounts of nitric oxide molecules in a single human breath utilizing a proprietary technology. Physician office measurement of eNO is a much awaited breakthrough in medical technology that provides physicians with a reliable tool to measure their patients’ respiratory inflammation better than ever before. Measurement of eNO has also been shown to optimize medication therapy and improve adherence among patients with asthma.

Like in the case of 10 year old Maya, who has moderate persistent asthma. Based on her record, her doctor wanted to optimize her therapy, but had no objective way measure of her airway inflammation to monitor her response. Once he had access to exhaled nitric oxide (eNO) measurement with the Insight system, he incorporated exhaled nitric oxide (eNO) testing into her treatment plan. When he first measured Maya’s eNO, he felt it was a little high for her age, but he wanted to establish her usual eNO levels over time before changing her medication. Over the next 8 weeks, he found that her eNO values stayed steady after initially fluctuating. Over the next 8 weeks, Maya’s eNO values decreased. Her doctor was very pleased with the results but the next time he measured her, there was an almost two-fold increase in her eNO bothered him but further investigation with Maya and her father revealed that she had missed taking her medication recently. Her eNO values dropped back down once she resumed her treatment. By continuing to monitor Maya’s eNO levels regularly, her doctor was confident that he could fine-tune her medication. This helps Maya go fishing with her dad every weekend and not worry about her asthma levels.

Apieron Inc received clearance for the Insight eNO system by the U.S. Food and Drug Administration (FDA) in March 2008.
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