NEW YORK, Dec. 28, 2011 /PRNewswire/ --Delcath Systems, Inc. (NASDAQ: DCTH) today announced that the Company's Galway, Ireland location has achieved ISO 13485:2003 Certification—an internationally recognized quality standard designed to ensure that medical device manufacturers have the necessary comprehensive quality management systems in place to safely design, develop, manufacture and distribute medical devices in the European Union (EU). ISO 13485 Certification is a regulatory requirement of the EU's Medical Device Directive, and represents an important step toward commercialization of the Delcath Hepatic CHEMOSAT® Delivery System following its European CE Mark approval in April 2011.
"ISO 13485 Certification of our Galway facility confirms that our manufacturing and quality systems meet the high standards required of medical device companies selling into Europe," said Eamonn P. Hobbs, CEO & President of Delcath Systems. "This achievement represents one more important milestone toward commercialization of CHEMOSAT in the EU, and we are looking forward to a successful initial launch of the product early next year."
About Delcath SystemsDelcath Systems, Inc. is a development stage specialty pharmaceutical and medical device company focused on oncology. Delcath's proprietary system for chemosaturation is designed to administer high dose chemotherapy and other chemotherapeutic agents to diseased organs or regions of the body, while controlling the systemic exposure of those agents. The Company's initial focus is on the treatment of primary and metastatic liver cancers. In 2010, Delcath concluded a Phase III metastatic melanoma study, and the Company recently completed a multi-arm Phase II trial to treat other liver cancers. The Company obtained authorization to affix a CE Mark for the Hepatic CHEMOSAT Delivery System in April 2011. The C
|SOURCE Delcath Systems, Inc.|
Copyright©2010 PR Newswire.
All rights reserved