Delcath Systems, Inc. operates as a specialty pharmaceutical and medical device company focusing on the field of oncology in the United States and internationally. The company’s initial focus is on the treatment of primary and metastatic liver cancers. Outside of the United States, 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). In 2012, the company obtained authorization to affix a CE Mark for the Generation Two CHEMOSAT system. The right to affix the CE mark allows the company to market and sell the CHEMOSAT system in Europe. The company is primarily involved in the development of CHEMOSAT/Melphalan hepatic delivery system that administers concentrated regional chemotherapy to the liver. 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). The Melphalan/HDS system has not been approved for sale in the United States. 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 other EU markets, such as Spain, Italy, France and The Netherlands, it focuses its efforts on clinical awareness and adoption. The company is initiating a phased Clinical Development Program for the CHEMOSAT/Melphalan HDS system in hepatocellular carcinoma, or primary liver cancer (HCC). The company is evaluating the best path forward for a potential indication for the Melphalan/HDS system in the treatment of ocular melanoma liver metastases. Sales and Marketing In 2011 the company obtained authorization to affix a CE Mark for the Generation One CHEMOSAT system. In 2012, the company obtained authorization to affix a CE Mark for the Generation Two CHEMOSAT system, and since this time all procedures in Europe have been performed with this version of the system. 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. Intellectual Property and Other Rights The company holds 6 United States patents, 12 foreign patents with patent validity in 28 countries, 7pending United States patent applications, and 8 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. History Delcath Systems, Inc., a Delaware corporation, was founded in 1988. The company was incorporated in 1988.
delcath systems inc (DCTH:NASDAQ CM)
810 Seventh Avenue
New York, NY 10019
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