Delcath Systems has submitted its CE mark technical file to its European Notified Body to obtain CE mark approval for its proprietary chemosaturation system, to market in the European Union (EU) as the Delcath Hepatic ChemoSAT Delivery System.
Delcath’s proprietary system for chemosaturation is designed to administer high dose chemotherapy and other therapeutic agents to diseased organs or regions of the body, while controlling the systemic exposure of those agents.
Delcath Systems said the receipt of the CE mark will allow the company to market and sell the product in countries in the EU.
Delcath Systems CEO and president Eamonn Hobbs said the EU represents an attractive opportunity for this product and filing in the EU is seeking an indication for the percutaneous intra-arterial administration of a chemotherapeutic agent (melphalan hydrochloride) to the liver.
"With the EU’s aging population and liver cancer rates on the rise we believe the Hepatic ChemoSAT Delivery System will fulfill an unmet clinical need for many liver cancer patients in this region," Hobbs said.
"With the submission of our technical file, and successful completion of the audits of our quality system and manufacturing facility, we expect potential CE mark approval in mid-2011."
"With respect to US regulatory status, we continue to expect to submit the remaining modules of our new drug application (NDA) to the US Food and Drug Administration (FDA) by the end of 2010, and will make additional announcements as we progress."