RITA Medical Systems Delays Shipment of Habib(TM) 4XFREMONT, Calif., Sept. 27 /PRNewswire-FirstCall/ -- RITA Medical Systems, Inc. (Nasdaq: RITA) a medical device company focused solely on cancer therapies, today announced that domestic shipments of the recently launched Habib 4X resection device will be delayed. During routine monitoring of customer experiences with the product in the field the company received isolated reports that the sterile packaging of some products had been compromised during shipping. The Company inspected the first manufacturing lots received from the registered manufacturer in the U.S. and determined that a problem existed. The Company has rejected subsequent product shipments from the manufacturer and has requested that all products previously shipped to U.S. customers be returned for replacement. The Company will not resume shipment of Habib 4X products to the U.S. market until a packaging redesign is implemented and validated by the manufacturer, and approved by the Company.

Joseph DeVivo, President and CEO of RITA Medical commented, "As a result of the possible compromise of the sterile packaging of several devices reported to us by U.S. customers, we have halted domestic shipment of Habib devices. When we learned of the possible problems we performed inspections of the manufacturing lots recently delivered to our U.S. facility in Georgia and determined that the packaging of these products could also be compromised during shipping to our customers. In response we have rejected these shipments from the manufacturer, and have asked all of our U.S. customers to return these products as soon as possible so that we may replace them with new product in redesigned packaging as soon as it becomes available."

Mr. DeVivo continued, "I think it is important to note that we believe this is a packaging issue only and that to date the Habib device has performed well in clinical settings. The ongoing product launch has generated a backlog of orders from surgeons worldwide. We believe that only those lots received for distribution in the U.S. are experiencing the packaging issue, however, we intend to modify worldwide packaging which may result in a backorder in Europe."

Mr. DeVivo concluded, "As a result of our actions, we expect to realize nominal revenue from the Habib device in the third quarter of 2005 and all existing and future orders will be backlogged until the packaging issue has been addressed. We expect the delay to be temporary and that during the fourth quarter of 2005 we will be able to fill our backorders as well as meet anticipated demand for the product. We expect to work closely with the manufacturer to address this issue in as timely a manner as possible."

The Habib 4X is manufactured in the United Kingdom by EMcision Limited, and received by RITA Medical's European and U.S. facilities for distribution to its customers. The Company is in the process of notifying the U.S. Food and Drug Administration (FDA) of the voluntary recall of the product and has notified all affected customers.

About RITA Medical Systems, Inc.

RITA Medical Systems develops, manufactures and markets innovative products for cancer patients including radiofrequency ablation (RFA) systems for treating cancerous tumors as well as percutaneous vascular and spinal access systems. The Company's oncology product lines include implantable ports, some of which feature its proprietary Vortex^® technology; tunneled central venous catheters; safety infusion sets and peripherally inserted central catheters used primarily in cancer treatment protocols. The proprietary RITA system uses radiofrequency energy to heat tissue to a high enough temperature to ablate it or cause cell death. In March 2000, RITA became the first RFA Company to receive specific FDA clearance for unresectable liver lesions in addition to its previous general FDA clearance for the ablation of soft tissue. In October 2002, RITA again became the first company to receive specific FDA clearance, this time, for the palliation of pain associated with metastatic lesions involving bone.

The statements in this news release related to the timing of resumed shipment and sales of the HABIB 4X Resection device, the fulfillment of backlog orders of the HABIB 4X Resection device, physician adoption of the HABIB 4X Resection device, and the performance of the HABIB 4X Resection device, are forward-looking statements involving risks and uncertainties that could cause actual results to differ materially from those in such forward-looking statements. Information regarding these risks is included in the Company's filings with the Securities and Exchange Commission.

SOURCE:
RITA Medical Systems, Inc. 09/27/2005

CONTACT:
Investors, Doug Sherk, +1-415-896-6820, or dsherk@evcgroup.com, or Jennifer Beugelmans, +1-415-896-6820
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Media:
Steve DiMattia, +1-646-277-8706, or sdimattia@evcgroup.com, all of EVC Group, for RITA Medical Systems, Inc.;
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Stephen Pedroff, VP Marketing Communications of RITA Medical Systems, Inc., +1-510-771-0400, or spedroff@ritamed.com Web site: http://www.ritamedical.com (RITA)