The clinical study included 34 patients who had primary lung cancer or lung metastases (cancer which has spread to the lung) and who were not surgical candidates. These patients were treated using RITA Medical Systems' radiofrequency ablation system. This 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 a local anesthetic and IV sedation.
Following treatment with the RITA system, the patients' progress was to be assessed over a one-year period using CT imaging and a quality of life survey. For 26 patients who had been followed for at least three months (mean follow-up of 8.6 months), complete tumor response was observed in 95 percent of the treated tumors. There were no major complications reported.
"We are at the threshold of a major advance in medicine. The data collected in this study clearly show that RITA has the potential to offer a new, revolutionary approach in the treatment of lung cancer for patients who are not candidates for surgical resection," said Professor Lencioni. "The high success rate and absence of major complications make RITA much more attractive than any non-surgical treatment currently available for these patients. In addition, the expected increase in the number of patients diagnosed with small tumors as a result of improved screening programs could even further enlarge the number of cases suitable for this procedure."
Barry Cheskin, RITA's President and Chief Executive Officer commented, "These results are a major step forward in our plans to commercialize this application overseas late in 2002. Lung cancer is one of several large potential applications for our technology outside of our very successful core liver cancer business." He added that the Company estimates the market opportunity for treating unresectable lung tumors is approximately $400 million in addition to other market opportunities of $500 million for unresectable liver cancer and $600 million for painful bone metastases.
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 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 investors, Matt Clawson, firstname.lastname@example.org, or media, Len Hall, email@example.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, firstname.lastname@example.org.
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SOURCE RITA Medical Systems, Inc.
Web site: http: //www.ritamedical.com
CONTACT: investors, Matt Clawson, email@example.com, or media, Len Hall, firstname.lastname@example.org, 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, email@example.com