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Delcath Systems is a specialty pharmaceutical and medical device company focused on oncology with an initial primary focus on liver cancer. The company's proprietary system for chemosaturation is designed to administer high dose chemotherapy and other therapeutic agents to diseased areas of the body.

The company today announced that it has received CE Mark approval for the second generation, patent pending, hemofiltration cartridge of Delcath System's proprietary Hepatic CHEMOSAT Delivery System. CE Marking confirms that a medical device complies with various European regulations. The receipt of the CE Mark allows Delcath to market and sell its Class III medical devices in the countries of the European Economic Area (EEA).

With the new hemofiltration cartridge, the CHEMOSAT system carries the same broad indication as the previous generation system, permitting doctors to use the product for the percutaneous intra-arterial administration of a chemotherapeutic agent, such as melphalan hydrochloride, to the liver of any patient who needs such therapy.

The new hemofiltration cartridge has been found to remove more than 98% of melphalan while removing significantly fewer blood platelets. In addition, Delcath believes CHEMOSAT may also help to improve the management of side effects on treated patients, which may lead to greater utilization of the company system in the future.

For further information about Delcath Systems and its CHEMOSAT product, please visit the company's website at www.delcath.com

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