Preliminary Results of Clinical Study of Bone Cancer Patients Shows RITA Medical Systems Technology Effective for Relieving Pain
The twelve adult patients involved in the study had painful metastatic bone tumors which did not respond to either conventional radiation and/or chemotherapy treatments. They were subsequently treated with RITA Medical Systems' proprietary radiofrequency ablation system, a minimally invasive procedure that enables physicians to deliver monitored and controlled levels of radiofrequency energy through an array of thin electrodes inserted into a cancerous tumor that heats and destroys the tumor.
Following treatment with the RITA system, the protocol required the patients' pain response to be measured one day following the procedure, then once a week for the month following the procedure, then every other week for a total of six months following the procedure. There were no serious complications reported and the patients experienced a dramatic reduction in pain.
Charboneau said, "Radiofrequency ablation was shown in the study to provide patients with significant pain relief from localized bone cancer and their quality of life was markedly improved."
RITA Medical Systems is currently focused on the treatment of unresectable liver cancer, but believes the technology will be applicable to a variety of other applications, including the treatment of pain for metastatic bone tumors, noted Barry Cheskin, RITA Medical Systems President and Chief Executive Officer.
"We are very encouraged by these early results," Cheskin added. "We are currently enrolling patients in our pivotal trial for the treatment of bone cancer in the U.S. and overseas and we expect to receive revenue from the use of the RITA system to treat patients with metastatic bone tumors in the fourth quarter of 2002."
Cheskin noted that the bone is the most common site of metastases, or the spread of cancer, and that as many as 50 percent of patients with this condition do not get adequate relief for the often intractable pain that accompanies it 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 more than $500 million annually, which is in addition to the $500 million market opportunity it estimates for its core liver cancer application.
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, 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