Pleasanton, California-based Spirosure (previously known as Spirometrix) has raised $15 million in Series C-2 financing for its breath analysis device, according to a statement. The funding round was led by returning investor NGK Spark Plugs Co. Ltd. of Japan, as well as other unnamed investors.
According to the statement, the money will be used to fund sales and regulatory processes in Europe, China, and Japan for Spirosure’s lead product, the Fenom PRO Point-of-Care Breath Analyzer. The portable, non-invasive, connected device measures patients’ fractional exhaled nitric oxide (FeNO), which can be increased due to asthma and other respiratory diseases. When incorporated as part of a patient assessment, it can allow physicians to predict potential exacerbations or identify non-adherent patients.
“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 percent of children, 33 percent of adults,” Solomon Ssenyange, chairman and CEO of Spirosure, said in a statement. “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.”
To measure FeNO, patients slowly exhale into the Fenom PRO for approximately 10 seconds, and within 30 seconds the device displays its results. In addition, users can use the accompanying Fenom CONNECT app to receive alerts, track symptoms, and develop a care plan with their provider.
“Artificial intelligence incorporated into Fenom PRO is designed to empower physicians to make the most informed clinical decisions possible about asthma diagnosis and management for their patients,” Ssenyange told MobiHealthNews.
The Fenom PRO has received a CE Mark for use by allergists, immunologists, and pulmonologists in Europe, with Spirosure submitting an FDA 510(k) submission in December, according to the company. The device is intended for use by adults and children aged 5 years or older.
Spirosure’s website also lists another product, the Fenom HOME, designed for more frequent in-home use and remote monitoring, although this device has not received any kind of regulatory approval.
As Spirometrix, the company received $8.6 million in Series B funding in late 2014, and announced $17.4 million in the summer of 2016. The latest round brings Spirosure to $41 million in total funding.