New Data Supports Efficacy of RITA Medical Systems RF Technology For Destroying Small Tumors in the Breast

March 19, 2002 at 12:00 AM EST
New Data Supports Efficacy of RITA Medical Systems RF Technology For Destroying Small Tumors in the Breast

New Data Supports Efficacy of RITA Medical Systems RF Technology For Destroying Small Tumors in the Breast

MOUNTAIN VIEW, Calif., March 18 /PRNewswire-FirstCall/ -- RITA Medical Systems, Inc. (Nasdaq: RITA) announced today that the latest results of a clinical feasibility study on the use of its proprietary radiofrequency (RF) ablation technology show the minimally invasive treatment appears to be effective in destroying small cancerous breast tumors. Data from the study, which was conducted at the M.D. Anderson Cancer Center in Houston, was presented by S. Eva Singletary, M.D. on Sunday at the Society of Surgical Oncologists 55th Annual Cancer Symposium in Denver. Dr. Singletary is a Professor of Surgery at the University of Texas, M.D. Anderson Cancer Center.

The data was gathered on 18 patients diagnosed with malignant breast cancer who were scheduled to undergo partial or total mastectomy and whose tumors were less than or equal to 2 centimeters in diameter. The study protocol called for each of the patients to undergo surgical resection of the tumors following the RF ablation so tests could be performed on the cancerous tissue to confirm the effectiveness of the procedure. The tumors were completely destroyed in 17 of the 18 patients (94 percent) without any complications reported.

Dr. Singletary said, "The next frontier of advances in breast cancer surgery is using new technology like radiofrequency ablation to treat the primary tumor in the breast. The potential advantage of this non-surgical lumpectomy is an improved cosmetic result with a simple outpatient procedure."

Barry Cheskin, RITA President and Chief Executive Officer, commented, "We look forward to continuing our research with Dr. Singletary and others to determine the full potential of the use of our RF ablation system for breast cancer. The strong evidence coming out of clinical trials such as those conducted at M.D. Anderson continues to validate the use of RF ablation to destroy many different types of cancerous tumors. In particular for breast cancer, we hope that RF ablation can eventually replace surgery."

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 over 35,000 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. Potential risks and uncertainties could include, but are not limited to, the Company's dependence on timely market acceptance of the RITA system, the outcome of current patent actions, the Company's history of operating losses and expectation that it will continue to incur significant operating expenses over the next several years, significant competition in the Company's industry, alternative therapies which could prove to be superior to the RITA system, the Company's lack of long-term clinical data, the Company's inability to protect its intellectual property, potential intellectual property lawsuits, the company's dependence on international revenues, the Company's dependence on third-party distributors including two primary international distributors, relationships with third-party distributors that could negatively affect the Company's sales and the need to establish reimbursement from payors in the United States and internationally. Further 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 further information, please contact: 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.; or Don Stewart, Chief Financial Officer of RITA Medical Systems, Inc., +1-650-314-3400, dstewart@ritamed.com.

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SOURCE RITA Medical Systems, Inc.
Web site: http: //www.ritamedical.com
CONTACT: 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.; or Don Stewart, Chief Financial Officer of RITA Medical Systems, Inc., +1-650-314-3400, dstewart@ritamed.com