TMCnet News
Aerocrine AB Receives Japanese Health Authority Clearance For NIOX VERO®Regulatory News: Aerocrine AB (STO:AEROB) announces today that Japanese health authorities have cleared the use of Aerocrine's FeNO-measuring device NIOX VERO® as a tool for assessing patients with allergic airway inflammation such as asthma. NIOX VERO® will be introduced on the Japanese market in the beginning of the second quarter 2015. The Japanese Pharmaceuticals and Medical Devices Agency's (PMDA) has granted Aerocrine regulatory clearance for NIOX VERO®. NIOX VERO® is the company's next generation device for measuring Fractional Nitric Oxide (FeNO) levels in clinical settings. The clearance in Japan follows the FDA approval in the US in November 2014. The NIOX VERO® was CE marked in the EU in September 2013. Aerocrine´s NIOX MINO® and now NIOX VERO® are the only FeNO measuring devices cleared by both the PMDA in Japan and also FDA in the United States. "Our current NIOX VERO® customers praise our new device for its portability, accuracy and ease of use. With NIOX VERO®, we improved the usability compared to our previous product, NIOX MINO®, by including a more ergonomic design with a handle to exhale into, an integrated visual display to help patients complete the test and rechargeable battery for portability. The NIOX VERO® also has a long life span with up to five years of use and can manage up to 15 000 tests", says Scott Myers, Chief Executive Officer at Aerocrine. The NIOX VERO® has been developed in cooperation with Panasonic (News - Alert) Healthcare Co., Ltd. (Panasonic Healthcare). Under the agreement, Aerocrine and Panasonic Healthcare will collaborate to develop products for airway inflammation monitoring for both clinical and personal use. Panasonic Healthcare will be responsible for the worldwide manufacture and supply of the devices and filters and Aerocrine will be responsible for regulatory approvals, method development and global commercialization. "Panasonic Healthcare is proud to work with Aerocrine on the joint development and manufacture of the NIOX VERO®. This is our first product based on the cooperation and we look forward to the response from Japanese physicians. We have put in a great effort in making it easy to use as it is an important tool in diagnosing patients with allergic airway inflammation such as asthma", says Kenji Yamane, President and CEO of Panasonic Healthcare Co., Ltd. On November 25th 2013, PMDA ceared the earlier 2009 model of NIOX MINO®, and sales have been above expectations in Japan. Many of the larger hospitals in the major cities are utilizing NIOX MINO® to measure FeNO as well as an increasing number of clinics (Specialists Doctors in Respiratory, Allergy or Pediatric). There are about 3 million asthmatics in Japan, of whom 37% have moderate to severe asthma and they are managed in both hospitals and clinics all around Japan. "Since the launch of NIOX MINO® we have experienced a dramatic increase in sales and we now anticipate that the NIOX VERO® will be equally or even better accepted by the Japanese physicians and patients alike" says Hideaki Hoki, president of Chest M.I Inc, exclusive distributor for NIOX products in Japan. Aerocrine's NIOX VERO® measures Fractional exhaled Nitric Oxide (FeNO)-levels, which are higher in people with asthma. It was Aerocrine's founders who first discovered the link between FeNO and asthma caused by allergic airway inflammation. Today, Aerocrine is the world leader in FeNO measurement and the only device manufacturer with a global presence, which includes FDA and PMDA clearance for devices to be used for clinical practice. About Aerocrine Aerocrine AB is a medical products company focused on improved management and care of patients with inflammatory airway diseases such as asthma. Within this sector, Aerocrine is the world leader. Aerocrine markets NIOX MINO® which enables fast and reliable point-of-care measurement of airway inflammation. This product plays a critical role in more effective diagnosis, treatment and follow-up of patients affected with inflammatory airway diseases. Aerocrine is based in Sweden with subsidiaries in the US, Germany, Switzerland and the UK. Aerocrine shares have been listed on the Stockholm Stock Exchange since 2007 (AERO-B.ST). For more information please visit www.aerocrine.com and www.niox.com. About Panasonic Healthcare Established in 1969, Panasonic Healthcare is involved in developing, manufacturing, selling and servicing medical equipment. It seeks to strengthen its core businesses, In Vitro Diagnostics including self-monitoring of blood glucose systems, its Medicom businesses involved in medical IT businesses and its life sciences based Biomedical business and to continue to pursue an important role in the provision of optimal healthcare for all. For further information on Panasonic Healthcare please visit http://www.panasonic-healthcare.com/. About CHEST M.I., INC. CHEST M.I., INC. started its business as a manufacturer of pulmonary function testing systems in 1965 and now is also known as a distributor specializing in respiratory products. The company manufactures Spirometer, Pulmonary Function test, Airway Hyper-Reactivity test, and FOT test systems. The company is oriented to develop and introduce high quality respiratory products to contribute Japan and world respiratory health. For further information on CHEST M.I., INC. please visit http://www.chest-mi.co.jp/ Aerocrine is 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 6:30 pm CET January 29, 2015. This information was brought to you by Cision http://news.cision.com |
