Asthma Monitoring Device Fenom Pro® Meets Clinical Precision Standards for Measuring Nitric Oxide in Adults and Children
March 4, 2020
CHICAGO and PLEASANTON, Calif. — March 4, 2020 ― Research published in the January 2020 issue of the Journal of Breath Research found Spirosure’s Fenom Pro® Asthma monitor provides a clinically precise measurement of Fractional exhaled Nitric Oxide (FeNO) in adults and children with asthma. The study also showed that either one six-second or one ten-second exhalation was adequate to obtain a clinically relevant and precise measurement.
“Fenom Pro gives healthcare providers a new choice for accurate FeNO measurement with shorter test times than NIOX VERO. In this study it met clinical precision needs and had excellent analytical precision when compared to the gold-standard of ozone chemiluminescence,” said Vivek Balasubramanyam, Vice President, Sales and Marketing, Spirosure. “We hope that accurate and easy FeNO measurements will help physicians improve asthma control by responding to changes in inflammation before they develop into symptoms.”
FeNO is the most established biomarker for diagnosing asthma. It can also be measured to confirm response to medications that target eosinophilic inflammation and identify suboptimal medication compliance.
The 2005 American Thoracic Society recommendations call for the average of two, 10-second exhalations to accurately measure nitric oxide. The European Respiratory Society technical standards propose one valid exhalation. This study shows that Fenom Pro can meet both organizations’ guidance for asthma monitoring.
“Adding FeNO to Vyaire’s comprehensive line of pulmonary function testing equipment helps us offer a state-of-the-art respiratory diagnostic suite,” said Gaurav Agarwal, CEO, Vyaire Medical. “Fenom Pro improves clinicians speed and accuracy when diagnosing asthma and keeping it under control.”
To evaluate the clinical precision of Fenom Pro in adults and children, researchers compared six and 10-second patient exhalations using NIOX VERO and Fenom Pro at three U.S. clinical research sites. During a single visit, each subject’s first FeNO measure (via exhalation) on Fenom Pro was compared to the average of the two FeNO measures on NIOX VERO. The study was done with 100 participants including 60 adults and 40 children who had clinically stable asthma, who had not smoked in the last six months, and had a less than 10-year history of smoking and otherwise stable respiratory health.
About Fenom Pro
Fenom Pro offers the fastest test time among similar devices available in the U.S. and requires the least amount of maintenance among similar devices. The measurements obtained from Fenom Pro can assist in evaluating treatment response for certain conditions, such as asthma. Data from Fenom Pro will also integrate with Vyaire’s SentrySuite® software platform, offering healthcare providers more context and information about each patient’s unique respiratory condition.
About FeNO
Nitric Oxide (NO) is produced in the lungs and becomes more concentrated when the lungs are inflamed due to allergic asthma. FeNO is a standardized measure of this concentration and provides a quick and non-invasive biomarker for airway inflammation. Measurement of FeNO helps assess the need for anti-inflammatory medication and supports ongoing monitoring of anti-inflammatory therapy for conditions like asthma. Routine FeNO testing can help allergists, pulmonologists and respiratory therapists determine the best treatment path, and avoid potentially unnecessary medicines.
About SPIROSURE
Spirosure Inc. was founded in 2011 in Pleasanton, California by Dr. Solomon Ssenyange and Ryan Leard. It is focused on improving quality of life for the 300 million people around the world who have asthma by offering tools that enable proactive intervention. In recent years, non-invasive measurement and monitoring of the fraction of exhaled nitric oxide (FeNO) in exhaled breath has become established as the biomarker of asthma.
Learn more at spirosure.com and fenomasthma.com.
About Vyaire Medical
Headquartered near Chicago, IL., Vyaire Medical - a global company dedicated to respiratory care — enables, improves and extends lives with an unyielding focus on improving patient outcomes and increasing value for customers. The company was formed in October 2016 to serve healthcare providers with innovative devices and service solutions across the respiratory and anesthesia continua of care. Vyaire’s legacy brands have a 65-year track record of pioneering and advancing respiratory diagnostics, ventilation, and anesthesia delivery & monitoring. From original brands including Bird, Bear, and JAEGER to industry leaders AirLife™, Vital Signs™, Viasys, and many others — Vyaire Medical is recognized, trusted and preferred by specialists in respiratory and anesthesiology healthcare worldwide.
Learn more at www.vyaire.com.
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