Delcath’s 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 CEO and president Eamonn Hobbs said with the CE mark in hand, they will now begin to build inventory and establish the commercialization infrastructure in Europe, including assembling a direct sales organization to cover countries in Northern Europe and establishing a network of third party distributors in Southern Europe.
"We will also begin establishing and training initial sites in select European countries as Centers of Clinical Excellence for the chemosaturation procedure," Hobbs said.
Delcath’s initial focus is on the treatment of primary and metastatic liver cancers.
In 2010, Delcath concluded a Phase III metastatic melanoma study, and recently completed a multi-arm Phase II trial to treat other liver cancers.
However, the company is yet to receive the US Food and Drug Administration approval for commercial sale of the Hepatic CHEMOSAT Delivery System.
