Spirometrix, a medical device company focused on breath analysis devices for the diagnosis and management of asthma, recently announced that its Fenom PRO Point-of-Care Breathalyzer has received CE marking and will now be commercially available in Europe.
Fenom PRO is a point-of-care, sensor-based portable analyzer that measures nitric oxide in exhaled breath, a biomarker that indicates airway obstruction in patients with asthma.
During inflammation, higher-than-normal levels of nitric oxide (NO) are released from epithelial cells of the bronchial wall. The concentration of NO in exhaled breath, or fractional exhaled nitric oxide (FeNO), can help to support a diagnosis of asthma when other objective evidence is lacking.
“FeNO monitoring in the management of asthma patients at the point of care has the potential to optimize asthma therapy, improve compliance of medication use and decrease the need for emergency visits and hospitalization,” James Wolfe, MD, clinical professor of Medicine at Stanford University and a scientific advisor to Spirometrix, said in apress release. “It should be noted that both American Thoracic Society and European Respiratory Society have issued guidelines recommending FeNO testing for the assessment, management, and long-term monitoring of asthma.”
According to J. Dean Zikria, CEO of Spirometrix, Fenom PRO Point-of-Care Breathalyzer is a respiratory digital ecosystem that incorporates information from other devices as well as from the environment (air quality, local pollen count and local pollution index). The device is programmed with algorithms that generate a pattern recognition and assist on asthma management.
“The entire Spirometrix team has been working very diligently to achieve this significant milestone,” Zikria said. “The Fenom PRO Point-of-Care Breathalyzer is the first-of-its-kind product in asthma that embraces several sensors and a digital ecosystem designed to effect documentation that may lead to enhanced clinical decision support.”
The company plans to begin testing the device in the U.S. this year, in anticipation of filing for approval from the U.S. Food and Drug Administration in the fall. The device was licensed from the laboratories of Professor Prabir Dutta at Ohio State University when Spirometrix was established in 2011.
Asthma, a disease characterized by variable and recurring respiratory symptoms, airflow limitation or obstruction, and bronchial hyper-responsiveness, affects 7% of the population in the United States.
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