医療従事者の為の最新医療ニュースや様々な情報・ツールを提供する医療総合サイト

Aerocrine Passes Regulatory Milestone in Japan

2013年04月04日 PM03:40
このエントリーをはてなブックマークに追加


 

SOLNA, Sweden

Aerocrine AB (STO:AERO-B) announces that the Japanese authority (PMDA) has approved its FeNO (fractional exhaled nitric oxide)-measuring device, NIOX MINO ® from 2008 as a tool for assessing patients with airway inflammation such as asthma.

The Japanese Pharmaceuticals and Medical Devices Agency (PMDA), decided on 28 of March 2013, after a thorough review, to grant the 2008 version of the NIOX MINO® marketing approval in Japan. As Aerocrine introduced a new version in 2010 of NIOX MINO, the approval will have limited impact on the company’s sales in Japan in the near future.

“We look upon this approval as a positive regulatory milestone. We are very proud of being the first company to receive approval for the FeNO-method in Japan,” said Tobias Bergenblad, Commercial Director Aerocrine for Asia.

Asthma – a growing health care problem

Asthma is a fast growing health care problem, which is caused by a chronic inflammation in the airways. Between 100 and 150 million people around the globe suffer from asthma and this number is rising. World-wide, deaths from this condition have reached over 180,000 annually according to statistics from WHO. There are about 3 million asthmatics in Japan of whom 7% have severe and 30% have moderate asthma.

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.

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 08:00 am on April 4, 2013.

This information was brought to you by Cision http://news.cision.com

CONTACT

Aerocrine AB
Scott Myers
Chief Executive Officer
Phone:
+46 768 788 379

Related Posts Plugin for WordPress, Blogger...

同じカテゴリーの記事 

  • サラダックス・バイオメディカル、サルバトーレ・J・サラモネ博士が権威ある C.E. Pippenger博士賞を受賞したと発表
  • Japan’s MHLW Approves PADCEV® (enfortumab vedotin) for Advanced Urothelial Cancer
  • VFMCRP announces approval for TAVNEOS® (avacopan) for the treatment of ANCA-associated vasculitis in Japan
  • TAE Life Sciences Announces Installation of First Accelerator-based Neutron Beam System for Biologically Targeted Radiation Therapy at Xiamen Humanity Hospital in China
  • New Study Evaluates the Feasibility of Using Masimo EMMA® Capnography on Mechanically Ventilated Neonates