Orlando, FL 3/20/12 (StreetBeat) -- Delcath Systems, Inc. (NASDAQ: DCTH) announced today that it has received the first commercial order for the Company's Hepatic CHEMOSAT® Delivery System from the European Institute of Oncology (Instituto Europeo di Oncologia – IEO) –a premier cancer treatment and research center in Europe. Delcath previously announced an initial launch and training agreement with the IEO on November 21, 2011."The first commercial order of our CHEMOSAT system is a significant milestone in Delcath's history, marking our transition from a research and development organization to a commercial enterprise," said Eamonn P. Hobbs, President and CEO of Delcath. "With the recent announcement of our fifth EU training center, we believe our launch plans for Europe are on track, and we expect to announce additional center agreements in the coming months. Meanwhile, the hiring and training of our direct sales force is gathering pace, the staffing of our contract medical science liaison team is continuing and we are evaluating potential third-party distribution partners to cover each of our targets markets in Southern Europe. We believe that our momentum is building and we are taking critical steps toward our goal of establishing CHEMOSAT as a new treatment option for patients with cancers in the liver in Europe."
CHEMOSAT is a proprietary product that utilizes chemosaturation technology, a minimally invasive, repeatable procedure that delivers high doses of chemotherapeutic drugs directly to the whole liver while minimizing systemic exposure of such drugs. CHEMOSAT received CE Mark in April 2011 as a Class III medical device with an indication for the percutaneous intra-arterial administration of a chemotherapeutic agent (melphalan hydrochloride) to the liver.
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 III 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 II trial to treat other liver cancers. The Company obtained authorization to affix a CE Mark for the Hepatic CHEMOSAT delivery system in April 2011. The right to affix the CE mark allows the Company to market and sell the CHEMOSAT system in Europe. The Company has not yet received FDA approval for commercial sale of its system in the United States. The Company continues with the preparation of its NDA submission and intends to seek FDA approval for commercial sale of its chemosaturation system with melphalan.
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