Spirosure Receives FDA Clearance to Sell Its Point-of-Care Asthma Monitor, Fenom Pro™

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Spirosure Inc. announced they received FDA clearance of its patent-protected Fenom Pro Asthma Monitor for use by allergists, immunologists and pulmonologists to help patients manage asthma by measuring the fraction of exhaled nitric oxide (FeNO) in their patients’ breath.

Spirosure reports FeNO is an established biomarker for airway inflammation in human exhaled breath. Measurement of FeNO by Fenom Pro is a method to measure the decrease in FeNO concentration in asthma patients that often occurs after treatment with anti-inflammatory pharmacological therapy as an indication of therapeutic effect in patients with elevated FeNO levels.

Spirosure’s Fractional exhaled Nitric Oxide (FeNO)-based Fenom Pro Asthma Monitor uses state-of-the-art technology with proprietary algorithms to detect exhaled nitric oxide (NO) molecules in concentrations of parts per billion (or “ppb”) in human breath. The noninvasive measurement occurs at the point of care where the patient exhales at a slow rate for 10 seconds to generate results in less than 30 seconds. FeNO is increased in some airway inflammatory processes, such as asthma, and decreases in response to anti-inflammatory treatment. FeNO measurement with Fenom Pro is designed to be used as part of regular assessment of patients by healthcare professionals and for monitoring of patients with asthma. Fenom Pro is suitable for children, approximately 7 to 17 years of age, and adults 18 years and older.

“Fenom Pro is a game-changing device for asthma management,” said Dr. Solomon Ssenyange, Chairman and CEO of Spirosure. “FeNO-monitoring of asthma patients at point of care not only offers significant potential to advance asthma therapy and monitor adherence to asthma-maintenance medication use, but also may reduce the risk of asthma emergency department visits and hospitalizations.”

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