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CMC Contrast Granted Orphan Drug Designation by the FDA for its Liver Specific MRI Contrast Media CMC-001
Date:11/27/2013

FDA decision to grant the Orphan Drug Designation to CMC-001 is an important milestone for CMC Contrast AB.  The company is now planning a pivotal phase III clinical program which in conjunction with the completed phase I and II clinical studies should enable CMC-001 to obtain regulatory approval and marketing authorization in the US. CMC-001 will then become available to patients in need of a liver MRI procedure for whom gadolinium based contrast agents are contraindicated or cannot be administered.

About CMC Contrast

CMC Contrast AB is a privately owned drug development company that specializes in developing targeted contrast agents for Magnetic Resonance Imaging (MRI). CMC Contrast AB's product CMC-001 is the world's first oral contrast agent for MRI of the liver. CMC-001 is an oral manganese-based contrast agent which enables safe liver enhancement in MRI, in patients for whom gadolinium based contrast agents are contraindicated or cannot be administered. A liver MRI scan is a specialized radiology procedure used to examine the liver to identify certain conditions or diseases which can be malignant cancerous or benign lesions.

CMC Contrast is based in Lund, Sweden, and funded by prominent VC investors including Sunstone Capital, Industrifonden and Øresund Healthcare. http://www.cmccontrast.com

Contact
Magnus Corfitzen
Chairman, CMC Contrast AB
Email: moc@cmccontrast.com
Tel: +45-40-80-48-63



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