The 10 adult patients in the study, including five men and five women who ranged in age from 57-76, had painful metastatic spinal tumors that were unresectable and were not candidates for or did not respond to conventional pain treatment including chemotherapy and radiation. All 10 patients were treated with RITA Medical Systems' proprietary radiofrequency ablation (RFA) system, which enables physicians in a minimally invasive procedure to deliver monitored and controlled levels of radiofrequency energy through an array of thin electrodes inserted into a cancerous tumor, thereby heating and destroying, or "ablating," the tumor. During the study, RFA was conducted with local anesthesia only and the patients were conscious and communicative throughout the procedure.
Following treatment with the RITA system, the patents' pain was assessed with the help of a Visual Analogue Scale. The mean follow-up time for these patients was approximately 6 months. In the nine patients who experienced relief, the average pain reduction was 74.4 percent. Back-pain related disability was reduced by an average of 27 percent and neurologic function was preserved in nine patients and improved in one. Also, magnetic resonance imaging showed no further tumor growth after the therapy in any of the patients. There were no complications reported.
RITA Medical Systems President and Chief Executive Officer Barry Cheskin commented, "This study represents another important advance for us and for the potential for radiofrequency ablation as a method to bring pain relief to cancer patients whose tumors have metastasized, or spread to the bone. The spine is one of the most common sites of bone metastases."
Cheskin noted that as many as 50 percent of patients with metastatic bone tumors do not get adequate relief from the often intractable pain associated with these tumors through conventional therapies such as chemotherapy, radiation or other drug therapies. The Company estimates the potential market opportunity for the treatment of metastatic bone cancer pain is around $600 million annually, which is in addition to the $500 million market opportunity it estimates for its core liver cancer application and the $400 million opportunity it estimates for its future lung cancer application.
The study was conducted by Dietrich H.W. Gronemeyer, M.D. and his colleagues at the Institute of MicroTherapy and the Department of Radiology and Microtherapy at the University of Witten/Herdecke, Germany as well as the EFMT Development and Research Center for Microtherapy in Bochum, Germany.
The study follows the significant preliminary results RITA reported at the end of November on a clinical study of pain relief focused on metastatic tumors to the bone, conducted at the Mayo Clinic and presented at the 87th Scientific Assembly and Annual Meeting of the Radiological Society of North America. In that study as well, the preliminary evidence shows that RFA appears to be safe and effective for relief from what is often described as intolerable pain. The company is currently enrolling patients in its pivotal trial for the treatment of bone cancer and expects to receive revenue from the use of the RITA system to treat pain in patients with metastatic bone tumors in the fourth quarter of 2002.
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 statements in this news release related to the company's plans to extend its technology to applications beyond the liver, statements related to expected sales from non-liver applications in 2002, and the company's projections of the market potential related to liver and non-liver applications 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 Don Stewart, Chief Financial Officer of RITA Medical Systems, Inc., +1-650-314-3400, firstname.lastname@example.org; or investors, Matt Clawson, email@example.com, or media, Len Hall, firstname.lastname@example.org, both of Allen & Caron Inc, +1-949-474-4300.
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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, email@example.com; or investors, Matt Clawson, firstname.lastname@example.org, or media, Len Hall, email@example.com, both of Allen & Caron Inc, +1-949-474-4300