Spirometrix receives CE mark for its Fenom PRO™ Point-of-Care Breathalyzer

Commercialization to start soon for company’s initial product, Fenom PRO™, a point-of-care portable breath analyzer that measures nitric oxide in exhaled breath, a biomarker that foreshadows airway obstruction

PLEASANTON, Calif., Aug. 30, 2016—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 whole Spirometrix team has been working very diligently to achieve this significant milestone and we believe that receiving CE Mark will maintain our strong momentum towards the market,” 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.

Spirometrix raises $17.4 million Series C financing

Funding will drive commercialization of the company’s initial product, Fenom PRO™, a point-of-care portable breath analyzer that measures nitric oxide in exhaled breath, a biomarker that foreshadows airway obstruction 

 

PLEASANTON, Calif., June 30, 2016—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 the closing of $17.4 million in the first round of a Series C financing. The financing was led by Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (600196.SH, 02196.HK), with participation from return backers NGK Spark Plug Co., LTD (NTK); South Valley Angels; Iconical; Ohio Innovation Foundation; and, Carmen Innovation LLC.

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.  Spirometrix is the vanguard of this significant opportunity: Including the Series C investment, Spirometrix has now raised a total of $29 million in three rounds of funding.

“We are extremely pleased not only to have Shanghai Fosun Pharmaceutical as a major financial and strategic partner in China, but also that our Series A and B lead investors have participated in this third round of financing,” said J. Dean Zikria, CEO of Spirometrix. “This Series C funding underwrites a launch-pad for Spirometrix to commercialize its initial product, the Fenom PRO Point-of-Care Breathalyzer, a first-of-its-kind offering in asthma that comprises several sensors as well as a digital ecosystem designed to prompt evidence 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.

“Fosun’s investment in Spirometrix is further evidence of the significant opportunity not only in the USA and EU but also in the growing Chinese market, for the use of our product and the data insights gained from over 20 million Chinese citizens who could potentially use our product,” said Zikria. “In addition, Series C funds will be used to finalize the development of a handheld breathalyzer for use  by asthma patients in measuring their FeNO levels at home. This device will be the first of its kind in the world.”  Zikria also added that the current funding will finance product launches in both the EU and USA within one year.

“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.”

“Lately, air pollution in China has triggered public consciousness to proactively manage health, especially in regard of respiratory health and wellness. By investing in Spirometrix, we hope to empower the public with a tool that not only better diagnoses asthma, but also actively monitors and manages this chronic disease,” said Chen Qiyu, Chairman of Fosun Pharma.

 

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 expects CE marking for European regulatory approval of the Fenom PRO™ this summer and to commence clinical trials for FDA approval later 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.

About Shanghai Fosun Pharmaceutical (Group) Co.,Ltd.

Established in 1994, Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (“Fosun Pharma”; stock code: 600196.SH, 02196.HK) is a leading healthcare Group in the PRC. Fosun Pharma strategically covers important segments of the healthcare industry value-chain, including pharmaceutical manufacturing and R&D, healthcare services, medical diagnosis, medical devices manufacturing and agent, as well as research and development, pharmaceutical manufacturing, medical diagnosis, medical devices, pharmaceutical distribution and retail, and healthcare services, making contribution to improving public people’s health. Fosun Pharma maintains a National Recognized Enterprise Technology Centre and a highly capable international R&D team, focusing on innovation and research of therapeutic areas including cardiovascular system, central nervous system, blood system, metabolism and digestive tract system, central nervous system, blood system, anti-infection and anti-tumor and .anti-infection diseases With its commitment to innovation for good health and creating a better future, Fosun Pharma will continue insisting on the strategic development approach of “organic growth with external expansion and integrated business operation,”. The Company strives  striving to be one of the first-class enterprises in the global healthcare market.

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.

 

Spirometrix Receives ISO 13485 Certification

Pleasanton, CA – Spirometrix announced today that it has received ISO 13485 certification. ISO 13485 represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices. It focuses on risk management effectiveness of corrective and preventive actions.  It demonstrates a commitment from management for quality throughout the product development lifecycle and the product’s lifespan with customers.

Spirometrix is excited to have achieved this certification as it sets the groundwork to achieve the United States Food and Drug Administration (FDA) Class II medical device designation and meeting the Medical Devices Directive 93/42/EEC requirements in the European Union.

“At Spirometrix, we are committed to developing the highest quality products in compliance with international standards and regulatory authorities. Receiving ISO 13485 certification is recognition for the quality processes we have adopted and is a direct reflection of the commitment we have to deliver innovative products in respiratory health.,” says Brian Awabdy, Director of Engineering Reliability and Quality at Spirometrix, Inc.

Click here for more information on the Spirometrix ISO 13485 certification.

About Spirometrix
Spirometrix is based in Pleasanton, California focusing on research, development and commercialization of novel breath analysis devices for application in disease diagnosis and management. Our mission is to provide cost effective, non-invasive products for the management of chronic pulmonary diseases such as Asthma, COPD, Cystic Fibrosis and Pulmonary Hypertension. Through the use of new sensors, proprietary algorithms and consumer technology we aim to improve health outcomes through preventive healthcare. http://www.spirometrix.com

For further information, please contact:
Spirometrix, Inc.
Brian Awabdy
Director of Engineering Reliability and Quality 
bawabdy@spirometrix.com
925.264.8116

Spirometrix Closes $8.6 Million Series B Financing

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 the closing of an $8.6 million Series B Preferred Stock financing. The financing was led by biosensor manufacturing partner NGK SPARK PLUG CO., LTD (hereafter NTK), which invested approximately $5 million, and also included current investor Simul Investments. As part of the financing, a member of NTK will join the Board of Directors of Spirometrix.

Spirometrix, founded in 2011, focuses on research, development and commercialization of novel breath analysis devices for application in disease diagnosis and management for asthma. In recent years, non-invasive measurement and monitoring of Nitric Oxide (NO) in the exhaled breath is becoming established as the biomarker of asthma.

Both parties' goals are well-aligned. Spirometrix gains access to sophisticated, high-quality mass production of sensors, and NTK gains access to a new market in medical devices for utilizing its existing NOx sensor technology.

"We are excited to have NTK as an investor, strategic partner, and member of our Board of Directors, given NTK's commitment to high-quality sensor design and manufacturing," said J. Dean Zikria, CEO of Spirometrix. "This is a significant step in our strategy of creating a unique offering in the asthma space that includes sensors as well as a digital ecosystem allowing for insights leading to better clinical decision support," added Mr. Zikria.

"NTK will strive to develop and manufacture this NO sensor with the aim of further promoting patient-friendly exhaled NO measurement. This relationship is NTK's steppingstone to business development in the medical device and diagnostic fields, where we plan on executing a long-term strategy," commented Mr. Shinichi Odo, CEO of NTK. 

About SPIROMETRIX

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

About NGK SPARK PLUG CO., LTD

NGK SPARK PLUG CO., LTD., headquartered in Nagoya, Japan, is a comprehensive ceramics-processing manufacturer. The company holds a world-leading share of spark plugs and automotive sensors for internal combustion engines and also offers a broad line of packages, cutting tools, bioceramics and industrial ceramics. The company's global network of sales and manufacturing organizations and over 12,000 employees deliver value creation to the world, contributing to a sustainable society by developing products related to the environment, energy, next-generation vehicles, medical devices and diagnostic tests. The company's belief is to embrace the challenge of a new era under the catch-phrase of "manufacturing is our only one, and number one, product."

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