Delcath Systems, Inc. Announces First Patient Treatment Using Second Generation Hemofiltration Cartridge

NEW YORK, April 13, 2012 /PRNewswire/ -- Delcath Systems, Inc. (NASDAQ: DCTH) today announced that the first treatment using the second generation hemofiltration cartridge of the Company’s proprietary Hepatic CHEMOSAT® Delivery System has been performed at the European Institute of Oncology (Instituto Europeo di Oncologia IEO), a premier cancer treatment and research center in Milan. A patient was treated for inoperable liver-dominant metastases from ocular melanoma, a case that represents the first use of the second generation hemofiltration cartridge in a clinical setting. The IEO treatment team reports the patient is doing well and has not suffered any procedure-related complications.

“With the second generation hemofiltration cartridge, we may be able to filter out even more chemotherapeutic agent from the blood as it leaves the liver and before it returns to the body than was possible with the first generation system,” said Dr. Alessandro Testori, surgical oncologist and Director of the Division of Melanoma and Skin-Muscle Sarcoma at the IEO. “This offers the potential to improve patient outcomes because we can maximize the effectiveness of the chemotherapy while significantly minimizing the potential side effects that can be associated with a more aggressive treatment approach.”

The new hemofiltration cartridge has demonstrated melphalan removal of greater than 98% during drug infusion in an in vivo study. Additionally, the new filter removed significantly fewer blood platelets in the same study. The Company received CE Mark for the new hemofiltration cartridge on April 5, 2012.

“We are pleased to finally be able to provide the second generation CHEMOSAT system to our early launch centers in Europe,” said Eamonn P. Hobbs, President and CEO of Delcath Systems. “Now that we are beginning to treat patients with the new system, we are confident that efficiency data we’ve seen in our in vivo studies will be validated in actual clinical use. We are also pleased that the team at the IEO is the first to begin exploring the benefits of the new system, and look forward to working with them and other early launch centers to establish the benefits of this system for patients with cancers in 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 Delcath 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. For more information, please visit the Company’s website at 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 benefits of the new hemofiltration cartridge for the CHEMOSAT system and market acceptance of the same, patient outcomes using the new hemofiltration cartridge, the timing of the supply and distribution of the CHEMOSAT system including the new hemofiltration cartridge to early launch centers 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.

SOURCE Delcath Systems, Inc.