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.
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.