Delcath Systems, Inc. operates as a specialty pharmaceutical and medical device company focusing on cancers of the liver. The company is developing its proprietary product—Melphalan Hydrochloride for Injection for use with the Delcath Hepatic Delivery System (Melphalan/HDS). In Europe, the company’s 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). The company’s primary focus is on the execution of its clinical development program in ocular melanoma liver metastases, intrahepatic cholangiocarncinoma, hepatocellular carcinoma (hepatocellular carcinoma (HCC) or primary liver), and certain other cancers that are metastatic to the liver. The company’s clinical development program for CHEMOSAT/Melphalan/HDS is comprised of: a planned Global Phase 3 clinical trial investigating overall survival in ocular melanoma liver metastases, and a Global Phase 2 clinical trial investigating Melphalan/HDS with and without sorafenib in HCC, opened for enrollment in the fall of 2014. In the United States, the Melphalan/HDS system is considered a combination drug and device product, and is regulated as a drug by the United States Food and Drug Administration (FDA). In Europe, the version of the company’s CHEMOSAT product is regulated as a Class IIb medical device and received its CE Mark in 2012. The company is in an early phase of commercializing the CHEMOSAT system in select markets in the European Union (United Kingdom and Germany) where the prospect of securing adequate reimbursement for the procedure is strongest. In 2011, the company obtained authorization to affix a CE Mark for the Generation One CHEMOSAT system and began European commercialization with this version of the CHEMOSAT system in 2012. In 2012, the company obtained authorization to affix a CE Mark for the Generation Two CHEMOSAT system. Intellectual Property and Other Rights The company holds 7 United States patents, 10 foreign patents with patent validity in 15 countries, 4 pending United States patent applications, and 2 pending foreign patent applications. Certain of its United States and foreign patents have already expired and other patents relating to the CHEMOSAT/Melblez Kit system would expire in 2016. Regulatory Environment The company’s products are subject to extensive and rigorous government regulation by foreign regulatory agencies and the FDA. In the European Economic Area (EEA), the CHEMOSAT Delivery Systems are subject to regulation as medical devices. In the EEA, the company must also comply with the Medical Device Vigilance System, which is designed to improve the protection of health and safety of patients, users and others by reducing the likelihood of recurrence of incidents related to the use of a medical device. In the EEA, the advertising and promotion of the company’s products is also subject to EEA Member States laws implementing the EU Medical Devices Directive, Directive 2006/114/EC concerning misleading and comparative advertising and Directive 2005/29/EC on unfair commercial practices, as well as other EEA Member State legislation governing the advertising and promotion of medical devices. History Delcath Systems, Inc., a Delaware corporation, was founded in 1988. The company was incorporated in 1988.
delcath systems inc (DCTH:NASDAQ CM)
1301 Avenue of the Americas
New York, NY 10019
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