RITA Medical Systems Receives Approval to Market Its Second Generation Products in Japan

July 30, 2002 at 12:00 AM EDT
RITA Medical Systems Receives Approval to Market Its Second Generation Products in JapanMOUNTAIN VIEW, Calif., July 30 /PRNewswire-FirstCall/ -- RITA Medical Systems, Inc. (Nasdaq: RITA) announced today that it has received approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) to market the Company's second generation StarBurst and StarBurst XL disposable electrodes in Japan, which are used in the Company's minimally invasive radiofrequency ablation procedure for the treatment of liver cancer. According to RITA's President and Chief Executive Officer Barry Cheskin, the approval will also allow the Company to begin the process of obtaining reimbursement approval for its products in Japan. The Company hopes to receive that reimbursement approval sometime next year. The marketing approval of the electrodes follows the March 2002 approval of the Company's newest Model 1500 series generators in Japan.

"The approval of the StarBurst and StarBurst XL, which we have been looking forward to for some time, is a major milestone for the Company," Cheskin said. "It will allow our distribution partner in Japan to begin selling our second generation electrodes, which we believe will improve the options available to patients with liver cancer in Japan and lead to increased sales of RITA products in the Japanese market."

Primary liver cancer is one of Japan's most serious health problems, striking its population at a rate that is approximately ten times that found in the United States. It is estimated that well over a hundred thousand patients will present with primary or metastatic liver cancer in Japan this year.

Prior to this approval of the StarBurst and StarBurst XL disposable electrodes, the RITA products available in Japan were older generation devices that had not been actively marketed in the United States since 1999. The new electrodes have the capability to destroy a volume of tumor nearly five times as large as the older generation products.

RITA's proprietary radiofrequency ablation system enables physicians to deliver monitored and controlled levels of radiofrequency energy into the cancerous tissue through an array of thin electrodes which heat and effectively destroy, or ablate, the targeted tissue. In most cases, this minimally invasive procedure can be performed using only local anesthetic and conscious sedation.

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, the Company believes that its minimally invasive technology may in the future be applied to other types of tumors, including tumors of the lung, bone, 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. The Company has sold approximately 40,000 of its disposable devices throughout the world.

The statements in this news release related to future sales and reimbursement approval in Japan as well as statements 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 and other risks is included in the Company's filings with the Securities and Exchange Commission.

RITA is a trademark of RITA Medical Systems, Inc.

For more information please contact Don Stewart, Chief Financial Officer of RITA Medical Systems, Inc., +1-650-314-3400, dstewart@ritamed.com; or Investors, Matt Clawson, matt@allencaron.com, or Media, Len Hall, len@allencaron.com, both of Allen & Caron Inc, +1-949-474-4300, for RITA Medical Systems, Inc.

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SOURCE RITA Medical Systems, Inc.
Web site: http: //www.ritamedical.com
CONTACT: Don Stewart, Chief Financial Officer of RITA Medical Systems, Inc., +1-650-314-3400, dstewart@ritamed.com; or Investors, Matt Clawson, matt@allencaron.com, or Media, Len Hall, len@allencaron.com, both of Allen & Caron Inc, +1-949-474-4300, for RITA Medical Systems, Inc.