SOLNA, Sweden--(BUSINESS WIRE)--Regulatroy News:
Aerocrine AB (STO:AERO-B):
Aerocrine AB (OMX Nordic Exchange: AERO) receives US FDA market clearance for the company’s next generation device, NIOX VERO®. Launch planned for Q1 2015.
Aerocrine received notification that the United States Food and Drug Administration (FDA) has granted market clearance for NIOX VERO, the company’s next generation device for measuring Fractional exhaled Nitric Oxide (FeNO) levels in the clinical setting.
“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 1 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 Dr. Kathleen Rickard, 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% of the population and accounting for an estimated 90 million patient interactions with healthcare providers each year. Over 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.
Aerocrine AB is a medical products company focused on the improved management and care of patients with inflammatory airway diseases. As the pioneer and leader in technology to monitor and manage airway inflammation, Aerocrine markets NIOX MINO® and NIOX VERO®. Both products enable fast and reliable management of airway inflammation and may therefore play a critical role in more effective diagnosis, treatment and follow-up of patients with inflammatory airway diseases such as asthma. Aerocrine is based in Sweden with subsidiaries in the U.S., Germany, Switzerland and the U.K. Aerocrine shares were listed on the Stockholm Stock Exchange in 2007.
Aerocrine may be required to disclose the information provided herein pursuant to the Securities Markets Act and/or the Financial Instruments Trading Act. The information was submitted for publication at 5:00 p.m. on November 6, 2014.
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