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

PLEASANTON, Calif.--(BUSINESS WIRE)--

Spirometrix, an emerging technology healthcare company focused on research, development and commercialization of novel breath analysis devices for applications in disease diagnosis and management, announced today that its Fenom PRO™ Point-of-Care Breathalyzer has received CE marking and can now be sold in Europe.

Spirometrix Inc., founded in 2011 by Dr. Solomon Ssenyange and Ryan Leard as a personal mission to aid asthma patients in the management of their ailment, focuses on the development and commercialization of novel breath analysis devices for application in diagnosis and management of asthma. 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 innovative laboratories at The Ohio State University as the company was founded.

"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."

About the Fenom PRO™ Point-of-Care Breath Analyzer
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 250⁺ million people worldwide who suffer from asthma. Spirometrix has received CE marking for European regulatory approval of the Fenom PRO™ and expects to commence clinical trials for FDA approval this fall.

About the Fenom HOME™ At-Home Breath Analyzer
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 nitric oxide (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.

About SPIROMETRIX
Founded in 2011, the Pleasanton, Calif.-based Spirometix Inc.'s mission is to provide cost-effective, non-invasive products for the diagnosis and management of chronic diseases such as asthma, COPD, and chronic pulmonary hypertension by using a nexus of consumer technologies for preventative healthcare through its proprietary set of sensors and algorithms.

CAUTION: 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 Federal Law (USA) to healthcare professionals in clinical trials to help manage asthma patients and are not available for sale at this time.

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