Spirometrix Receives CE Mark for Its Fenom PRO Point-of-Care Breathalyzer

Spirometrix, an emerging company focused on research, development and commercialization of breath analysis devices for applications in disease diagnosis and management, has received CE Marking for its Fenom PRO Point-of-Care Breathalyzer.
 
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. The sensor based technology was licensed from professor Prabir Dutta’s laboratories at The Ohio State University as the company was founded in 2011.
 
“The entire Spirometrix team has been working very diligently to achieve this significant milestone, and we believe that receiving CE mark will maintain our strong momentum toward commercialization,” said J. Dean Zikria, CEO of Spirometrix. “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 Spirometrix respiratory digital ecosystem includes data from other devices as well as the environment, such as local pollen count, local pollution index and air quality—which allow for algorithmic analysis that leads to pattern recognition and pattern management in asthma —for the first time, according to Zikria.
 
“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,” added James Wolfe, M.D., clinical professor of medicine at Stanford University and a scientific advisor to Spirometrix. “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.”
 
The Spirometrix Fenom PRO Point-of-Care Breath Analyzer is a portable, battery-operated device that comprises a solid-state senor which uses an electrochemical reaction to yield a millivolt output, which is then translated by an algorithm into nitric oxide (NO) levels. At the physician’s office or in the hospital, the patient breathes into the Fenom PRO device for about 10 seconds. The device then measures the NO content in the lungs, yielding a result in about 30 seconds. The Fenom PRO device connects automatically to a cloud-based decision repository and support system that will offer ‘big data’ insights about the more than 250 million people worldwide who suffer from asthma. Spirometrix expects to commence clinical trials this fall for U.S. Food and Drug Administration approval of the device.
 
In addition to the Fenom PRO Point-of-Care Breath Analyzer, Spirometrix also is developing the Fenom HOME At-Home Breath Analyzer, the world’s first handheld device designed to provide exhaled nitric oxide information to an asthmatic individual. Like Fenom PRO, the portable and battery-operated Fenom HOME device uses an electrochemical reaction to yield a millivolt output, which is then translated by an algorithm into exhaled FeNO levels. The patient breathes into the Fenom HOME device for about 10 seconds. The device then measures the NO content in the lungs, yielding a result in about 30 seconds. The Fenom HOME device also connects automatically to a cloud-based decision repository and support system. Spirometrix expects to commence clinical trials with Fenom HOME by year-end.

Spirometrix Inc., founded by Dr. Solomon Ssenyange and Ryan Leard to aid asthma patients in the management of their ailment, focuses on the development and commercialization of breath analysis devices for application in diagnosis and management of asthma. The Pleasanton, Calif.-based company’s mission is to provide cost-effective, non-invasive products for the diagnosis and management of chronic diseases such as asthma, chronic obstructive pulmonary disease, and chronic pulmonary hypertension by using a nexus of consumer technologies for preventative healthcare through its proprietary set of sensors and algorithms.
 
The Fenom PRO Point-of-Care Breath Analyzer and the Fenom HOME At-Home Breath Analyzer are investigational devices that provide exhaled nitric oxide information to a physician at point-of-care or to an asthmatic individual. Fenom PRO and Fenom HOME are breath monitors limited for use by U.S. federal law to healthcare professionals in clinical trials to help manage asthma patients and are not available for sale at this time.