NEW YORK , February 4 , 2013 - Delcath Systems, Inc. (NASDAQ: DCTH) today announced that the Institut für das Entgeltsystem im Krankenhaus (InEk), the German federal reimbursement agency, has established a reimbursement pathway for the treatment of patients with liver metastases with the Delcath Hepatic CHEMOSAT® Delivery System for melphalan hydrochloride. The decision by the InEK followed an endorsement by the German Radiology Association, which prompted 47 cancer centers throughout Germany to submit applications under the Neue Untersuchungs- und Behandlungsmethoden (NUB) scheme for new technology reimbursement at specific hospitals. The Value 4 status given to the CHEMOSAT procedure, while not mandating reimbursement, allows participating cancer centers to negotiate reimbursement coverage for the CHEMOSAT procedure with all insurers serving their region. Under the NUB scheme, reimbursement pathways will potentially be available for treatment with CHEMOSAT regardless of primary cancer origin.
Eamonn P. Hobbs, President & CEO of Delcath said, "This is excellent news for both patients in Germany and Delcath, as it represents a significant positive step in our efforts to fully commercialize CHEMOSAT in Europe. This is the first reimbursement mechanism for our procedure in Germany, the biggest market for CHEMOSAT in the European Union. It is important to note that the application for coverage was supported by 47 cancer centers across the country, which we believe speaks to the medical need physicians in Germany see for CHEMOSAT. We will continue to work closely with the participating hospitals to achieve reimbursement with the insurers. With a direct sales force in place and training of the additional centers in Germany on the way, we are now in a good position to begin growing this market for CHEMOSAT."
About Delcath Systems
Delcath Systems, Inc. is a specialty pharmaceutical and medical device company focused on oncology. 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. The Company's initial focus is on the treatment of primary and metastatic liver cancers. In 2010, Delcath announced that its randomized Phase 3 clinical trial for patients with metastatic melanoma in the liver had successfully achieved the study's primary endpoint of extended hepatic progression-free survival. The Company also completed a multi-arm Phase 2 trial to treat other liver cancers. The Company obtained authorization to affix a CE Mark for the Generation Two CHEMOSAT® delivery system for melphalan hydrochloride in April 2012. The right to affix the CE mark allows the Company to market and sell the CHEMOSAT system for melphalan hydrochloride in Europe. In October 2012, the Company satisfied all of the requirements to affix the CE Mark to the Hepatic CHEMOSAT Delivery System device for intra-hepatic arterial delivery and extracorporeal filtration of doxorubicin hydrochloride injection, providing a regulatory pathway for the CHEMOSAT Delivery System to deliver and filter doxorubicin for countries in Asia that accept the CE Marking as part of their national regulatory requirements. The Company has not yet received FDA approval for commercial sale of its system in the United States. The Company's NDA has been accepted for filing and substantive review by the FDA. For more information, please visit the Company's website at www.delcath.com.