Delcath Systems Inc is a Delaware corporation, incorporated on August 5, 1988. The Company is a late-stage clinical development company with early commercial activity in Europe focused on cancers of the liver. It is a specialty pharmaceutical and medical device company developing its proprietary product-Melphalan Hydrochloride for Injection for use with the Delcath Hepatic Delivery System (Melphalan/HDS). In Europe, its proprietary system to deliver and filter melphalan hydrochloride is marketed as a device under the trade name Delcath Hepatic CHEMOSAT Delivery System for Melphalan (CHEMOSAT). Its primary focus is on the execution of its clinical development program (CDP) in ocular melanoma liver metastases (mOM), intrahepatic cholangiocarncinoma (ICC), hepatocellular carcinoma (HCC or primary liver), and certain other cancers that are metastatic to the liver. The Company currently operates in one business segment, which is the development and commercialization of CHEMOSAT/Melphalan/HDS. Its competitors include Covidian, Biocompatibles, Merit, CeleNova, SirTex, AngioDynamics, and many others. The Company currently holds eight U.S. utility patents, one U.S. design patent, six pending U.S. utility patent applications (one of which has been allowed), four issued foreign counterpart utility patents, six issued foreign counterpart design patents, and eight pending foreign counterpart patent applications (one of which has been allowed). The Company's products are subject to extensive and rigorous government regulation by foreign regulatory agencies and the FDA.
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