NEW YORK, Feb. 16, 2012 /PRNewswire/ -- Delcath Systems, Inc. (NASDAQ: DCTH) announced today that the Company has entered into an initial launch and training agreement for the Delcath Hepatic CHEMOSAT® Delivery system with University Medical Center Schleswig-Holstein (Kiel Campus), one of the largest European centers for medical care and the second cancer center in Germany to commercially utilize the CHEMOSAT system to treat patients. Under the terms of the agreement, the Company will provide the University Medical Center Schleswig-Holstein with logistics and clinical training support in the performance of chemosaturation therapy using the CHEMOSAT system. Training at the University Medical Center Schleswig-Holstein is expected to begin in April 2012.
Prof. Dr. med. Thomas Becker, Director of the Department of General and Thoracic Surgery, said, "I am excited that our medical center will begin using Delcath's CHEMOSAT system to treat cancers in the liver. Gaining experience with this device and procedure is in line with our international reputation for leadership in medical care as well as excellent research results."
Axel Hauschild, MD, Professor of Dermatology in the Department of Dermatology, said, "Our team is committed to translating novel scientific developments and findings into new options for therapies. Clinical research suggests that CHEMOSAT will offer us a clinically significant tool in treating melanoma liver metastases with melphalan, and we're eager to begin providing therapy to our patients.""We are proud of the addition of University Medical Center Schleswig-Holstein to the growing number of European sites providing therapy with the CHEMOSAT system," said Eamonn P. Hobbs, President and CEO of Delcath Systems. "This second clinical site in Germany not only expands the access in the largest market in Europe, but provides further validation that our years of research and development have produced a product that's attracting the interest of Europe's best cancer centers."
About the University Medical Center Schleswig-HolsteinThe University Medical Center Schleswig-Holstein is one of the largest European centers for medical care. As the only maximum care provider in Schleswig-Holstein it covers the entire spectrum of modern medical and health care. At the University Medical Center Schleswig-Holstein, 2,000 physicians, scientists and researchers, and 3,600 health staff treat over 360,000 inpatients and outpatients in 80 clinics and institutes.
About Delcath SystemsDelcath Systems, Inc. is a development stage 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 concluded a Phase III metastatic melanoma study, and the Company recently 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 Company has not yet received FDA approval for commercial sale of its system in the United States. For more information, please visit the Company's website at http://www.delcath.com/.
The Private Securities Litigation Reform Act of 1995 provides a safe harbor for forward-looking statements made by the Company or on its behalf. This news release contains forward-looking statements, which are subject to certain risks and uncertainties that can cause actual results to differ materially from those described. Factors that may cause such differences include, but are not limited to, uncertainties relating to: the future use and adoption of the CHEMOSAT system by the University Medical Center Schleswig-Holstein, future initial launch and training agreements with other cancer centers in Europe, CE Marking for the Generation Two system and the timing of our commercial launch in Europe, the time required to build inventory and establish commercial operations in Europe, adoption, use and resulting sales, if any, for the Hepatic CHEMOSAT delivery system in the EEA, our ability to successfully commercialize the chemosaturation system and the potential of the chemosaturation system as a treatment for patients with terminal metastatic disease in the liver, acceptability of the Phase III clinical trial data by the FDA, our ability to address the issues raised in the Refusal to File letter received from the FDA and the timing of our re-submission of our NDA, re-submission and acceptance of the Company's NDA by the FDA, approval of the Company's NDA for the treatment of metastatic melanoma to the liver, adoption, use and resulting sales, if any, in the United States, approval of the current or future chemosaturation system for other indications, actions by the FDA or other foreign regulatory agencies, our ability to obtain reimbursement for the CHEMOSAT system, our ability to successfully enter into distribution and strategic partnership agreements in foreign markets and the corresponding revenue associated with such foreign markets, uncertainties relating to the results of research and development projects and future clinical trials, and uncertainties regarding our ability to obtain financial and other resources for any research, development and commercialization activities. These factors, and others, are discussed from time to time in our filings with the Securities and Exchange Commission. You should not place undue reliance on these forward-looking statements, which speak only as of the date they are made. We undertake no obligation to publicly update or revise these forward-looking statements to reflect events or circumstances after the date they are made.Contact Information: Investor Contact:
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Janine McCargoEVC Group
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