FDA Clears FENO Testing Tool from Aerocrine

Aerocrine AB received U.S. Food and Drug Administration (FDA) clearance for its next-generation device called Niox Vero, which measuring fractional exhaled nitric oxide (FENO) levels in the clinical setting.

A full launch planned for first calendar quarter of 2015.
 
The Swedish company’s technology focus is on products that improve airway inflammatory conditions.

“The portability and patient-centered improvements provided by Niox Vero will make it more practical for specialists as well as primary care physicians to make FENO testing a routine part of identifying and managing allergic airway inflammation in patients with diagnosed or suspected asthma,” said Scott Myers, CEO of Aerocrine AB.

Niox Vero is a small, point-of-care device that provides a patient’s FENO score in about one minute after a simple 10-second exhalation. The device improves on the previous generation Niox Mino by including a rechargeable battery for portability within the clinical setting and an integrated visual display to help patients complete a successful exhalation. Aerocrine’s Niox Mino and now Niox Vero are the only FeNO measurement devices cleared by the FDA and commercially available in the United States.

“FENO testing is an important addition to clinicians’ tool set because it is the only way to objectively identify and manage allergic airway inflammation, which is the leading cause of asthma symptoms,” said Kathleen Rickard, M.D., chief medical officer at Aerocrine. “Routine FENO testing helps clinicians find hidden and under-treated allergic airway inflammation, which has been shown to help reduce asthma exacerbations by up to 50 percent compared to usual care.”

Asthma is one of the most common diseases in the United States, affecting 8-10 percent of the population and accounting for an estimated 90 million patient interactions with healthcare providers each year. More than half of those patient interactions are with adult and pediatric primary care practitioners. The disease has no cure and proper diagnosis and management of the disease are key to obtaining optimal control of a patient’s asthma.