PLEASANTON, Calif.--(BUSINESS WIRE)--Spirosure Inc., developer of the Fenom PRO Point-of-Care Breath Analyzer, announced today that it is raising a Series C-2 financing of $15 million, which is being led by returning investor NGK Spark Plugs Co. Ltd. of Japan with participation from additional existing investors. The funds being raised will be used for sales and regulatory activities in Europe, China and Japan where the company is recruiting teams to commercialize its product. The Fenom PRO is CE-marked for use in Europe by allergists, immunologists and pulmonologists. On December 11, 2017, Spirosure announced that it completed an FDA 510(k) submission seeking U.S. clearance of Fenom PRO.
“Today’s standard for diagnosing and monitoring asthma is characterized by products, technologies and procedures that haven’t changed significantly in decades, offering limited support for clinicians to make better clinical decisions for their patients, while large numbers of asthmatics go undiagnosed: 50% of children, 33% of adults,” said Solomon Ssenyange, Ph.D., Chairman and CEO of Spirosure. “Our investors recognize Fenom PRO represents a dramatic advance for allergists, pulmonologists and primary care physicians in diagnosing, managing and monitoring patients’ asthma. This connected medical device is comprised of several sensors along with a digital ecosystem designed for supporting their clinical decisions.”
CAUTION: Fenom PRO™ Point-of-Care Breath Analyzer is an investigational device in the United States that is intended to provide exhaled nitric oxide information to a physician at point of care. Fenom PRO™ is not currently available for sale in the United States.