Initial Clinical Data Shows RITA Medical Systems Radiofrequency Ablation Technology Effective in Treating Metastatic Lung Tumors
The clinical study was based on 10 patients whose colorectal cancer had metastasized to their lungs and was considered to be unresectable. The patients' lung tumors, which ranged in size from 0.4 to 3.0 centimeters, 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 assessed for one year using CT imaging, serum tumor marker measurement and a quality of life survey. Local tumor control was achieved in the majority of patients with low or only moderate morbidity. Median follow-up in this study was 256 days.
"The progress we made with these patients shows that radiofrequency ablation can be an effective treatment for metastatic colorectal carcinoma to the lungs when surgery is not an option," said Dr. Glenn. "This is a significant advance for the hundreds of thousands of people around the world currently suffering from this life threatening disease."
"We have already expanded this study to several other sites overseas, and are now including patients with unresectable primary tumors as well as those unresectable tumors that have spread to the lung from various locations, not just from colorectal cancer," said Barry Cheskin, RITA Medical Systems President and Chief Executive Officer. He added that the majority of lung tumors are unresectable at the time of diagnosis.
The Company's radiofrequency ablation technology is currently focused on the ablation or destruction of unresectable liver lesions, for which it was specifically cleared by the U.S. Food and Drug Administration in March 2000. The Company also has a broad FDA clearance for the use of the RITA system to ablate any soft tissue and it believes its technology will in the future be applicable to lung tumors and other types of tumors, including those of the bone, breast, prostate and kidney.
Cheskin said, "This study, and others currently underway, offer a glimpse of the significant promise of our radiofrequency ablation system in a variety of clinical applications. As thought leaders in surgery, radiology and oncology continue to adopt and promote the advantages of radiofrequency ablation, we believe opportunities to expand our platform into new applications will continue to grow."
The Company estimates the market opportunity for treating unresectable lung tumors is approximately $500 million. The Company also estimates the combined market opportunity for its core liver cancer application, the treatment of metastatic bone cancer pain in patients who have not responded to conventional treatments, and the treatment of unresectable lung tumors is approximately $1.5 billion.
The Company believes that it will receive nominal revenue from the
international use of the RITA system to treat unresectable lung tumors at the
very end of 2002, and revenue from the use of the RITA system to treat
patients with metastatic bone tumors during the fourth quarter of next year.
About RITA Medical Systems:
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, 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 30,000 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, 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 include 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 and alternative therapies which could prove to be superior to the RITA system. Further information regarding these and other risks is included in the company's periodic filings with the Securities and Exchange Commission, including the company's Report on Form 10-K for the year ended December 31, 2000 and the company's Report on Form 10-Q for the quarters ended March 31, 2001, June 30, 2001 and September 30, 2001.
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