RITA Medical Systems Receives FDA Clearance For Its New Side-Deployment Electrode

RITA Medical Systems Receives FDA Clearance For Its New Side-Deployment Electrode

MOUNTAIN VIEW, Calif., May 5 /PRNewswire-FirstCall/ -- RITA Medical Systems, Inc. (Nasdaq: RITA) today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its Side-Deployment Electrode, its newest radiofrequency ablation tool designed to safely and precisely ablate small tumors. The Company plans to make the new system available to physicians this month.

The Side-Deployment Electrode is a small gauge needle that allows physicians, using ultrasound imaging guidance, to deliver radiofrequency electrodes directly through the skin and into the tumor in a minimally invasive procedure. This product works much like a hypodermic needle and can ablate a tissue volume of up to 2 centimeters in diameter. It is currently approved in the U.S. to treat liver and bone tumors and approved in Europe to treat lung, kidney, liver, bone and other small tumors.

The Side-Deployment Electrode is the newest addition to RITA's line of electrodes for radiofrequency ablation. The Company now offers electrodes that can ablate tissue volumes ranging from 2 to 7 centimeters in diameter, the widest range currently available on the market.

"This FDA clearance is the latest in a series of regulatory initiatives aimed at strengthening our market position by making the RITA system the most flexible and effective radiofrequency device designed to precisely ablate cancerous and benign tumors," commented RITA's Chief Financial Officer Donald J. Stewart. "The Side-Deployment Electrode offers physicians an effective tool to ablate smaller tumors, which are especially prevalent in cases of lung and kidney cancer."

About RITA Medical Systems, Inc.

RITA Medical Systems develops, manufactures and markets innovative products for patients with solid cancerous or benign tumors. The proprietary RITA system uses radiofrequency energy to heat tissue to a high enough temperature to ablate it or cause cell death. While the Company's current focus is on liver cancer and metastatic bone cancer, the Company believes that its minimally invasive technology may in the future be applied to other types of tumors, including tumors of the lung, breast, uterus, prostate and kidney. The Company has received regulatory clearance in major markets worldwide, including the United States. In March 2000, RITA became the first radiofrequency ablation 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 Company has sold over 45,000 of its disposable devices throughout the world.

The statements in this news release related to the Company's plans to extend its technology to applications beyond the liver 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.

RITA and StarBurst are trademarks of RITA Medical Systems, Inc.

For further information please contact: Matt Clawson (investors), matt@allencaron.com, or Len Hall (media), len@allencaron.com, both of Allen &

Caron Inc, +1-949-474-4300, for RITA Medical Systems, Inc.; or Don Stewart, Chief Financial Officer of RITA Medical Systems, Inc., +1-650-314-3400, dstewart@ritamed.com

SOURCE RITA Medical Systems, Inc.