Spirosure develops the Fenom PRO, a point-of-care breath analyzer intended to provide exhaled nitric oxide information to guide asthma diagnosis, management and monitoring. The connected medical device combines several sensors with a digital ecosystem to support clinicians' decisions. Fenom PRO is CE-marked for use in Europe by allergists, immunologists and pulmonologists and is investigational in the United States. Spirosure completed an FDA 510(k) submission on December 11, 2017 seeking U.S. clearance; the device is not currently available for sale in the U.S. The company is commercializing Fenom PRO internationally and is recruiting teams for sales and regulatory activities in Europe, China and Japan. Spirosure is headquartered in Pleasanton, California. Spirometrix develops and commercializes breath-analysis devices that measure exhaled nitric oxide (FeNO) for asthma diagnosis and management. Its core products are the Fenom PRO point-of-care breathalyzer and the Fenom HOME handheld at-home breathalyzer, both using a solid-state electrochemical sensor and cloud-connected analytics. The company also builds a respiratory digital ecosystem that integrates device data with environmental inputs (pollen, pollution, air quality) for algorithmic pattern recognition and clinical decision support. Spirometrix licensed its sensor-based technology from Professor Prabir Dutta’s laboratories at The Ohio State University. The company expects CE marking for the Fenom PRO this summer and to commence FDA clinical trials for Fenom PRO later this fall, with Fenom HOME clinical trials slated to begin by year-end. Financially, Spirometrix closed a $17.4 million Series C and has raised $29 million in three rounds to date to fund product finalization and imminent commercial launches in the EU and USA. Spirometrix is an emerging healthcare technology company founded in 2011 and based in Pleasanton, Calif., that develops novel breath analysis devices focused on respiratory disease. Its core product line centers on non-invasive measurement and monitoring of exhaled nitric oxide (NO) as a biomarker for asthma. The company aims to combine sensors with a digital ecosystem to provide insights and clinical decision support for disease management. Spirometrix’s mission targets cost-effective, non-invasive products for chronic conditions including asthma, COPD, and chronic pulmonary hypertension using proprietary sensors and algorithms. The company recently closed a financing that strengthens its ability to scale sensor production through a strategic manufacturing partnership. The NTK relationship is intended to provide mass-production capability and support commercial deployment of Spirometrix’s devices.

Total raised

$41M

Funding rounds

3

Latest round

Series C

Latest activity

Jan 2018