Multi-Center Study Shows RITA Medical Systems Radiofrequency (RF) Technology Effective at Destroying Lung Tumors
MOUNTAIN VIEW, Calif., June 2 /PRNewswire-FirstCall/ -- RITA Medical Systems, Inc. (Nasdaq: RITA) today announced that the results of a multi-center clinical study on the use of its proprietary radiofrequency (RF) ablation technology show the minimally invasive treatment is effective in destroying cancerous lung tumors, including primary lung tumors and lung metastases (cancer that has spread to the lung), when surgery is not an option. Overall, the majority of lung cancer patients are not considered surgical candidates.
Data from the study, which is being conducted at UCLA, St. George Hospital in Sydney, Australia, Pisa University Hospital in Pisa, Italy and the University of Essen in Essen, Germany, were presented at the 39th Annual Meeting of the American Society of Clinical Oncologists on May 31 at McCormick Place in Chicago. A total of 63 patients have taken part in the study to date.
All of the patients had either primary lung cancer or lung metastases and were treated using RITA Medical Systems RF ablation system. This system enables physicians to deliver monitored and controlled levels of RF 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.
One part of the study, including 30 patients (21 males and 9 females aged 50-83 years who had exhausted radiation and chemotherapy alternatives), focused on non-small-cell (primary) lung cancer showed that ablation was successful in all cases (32 of 32 lesions) and complete ablation of treated lesions was confirmed by the absence of tumor re-growth over a follow-up period of six months or more in 13 (93 percent) of 14 lesions in 14 patients. The study was led by Professor Riccardo Lencioni, M.D., a Professor of Diagnostic and Interventional Radiology at the University of Pisa, and included patients of Robert Suh, M.D. of the Department of Radiological Sciences at the UCLA School of Medicine.
"We continue to see remarkable results with the RITA system and very few complications," Professor Lencioni said. "I believe the RITA system is an important and effective alternative for many lung cancer patients, especially when you consider most of them are not candidates for surgical resection and chemotherapy and radiation have not been entirely satisfactory in terms of long-term survival outcomes."
The data in another part of the study, including a total of 33 patients (69 tumors) with colorectal metastases to the lung who had undergone prior chemotherapy (64 percent), surgery (13 percent) or radiation therapy (6 percent), showed that 94 percent of the tumors showed a positive response (stable or decreased size) in follow-up examinations after six and 12 months. This part of the study was led by Derek Glenn, M.D. of St. George Hospital, Dr. Suh of UCLA and Caroline Dereskewitz, M.D. of the University of Essen.
"RF ablation provides effective local tumor control with low morbidity and may prove to be an important adjuvant therapy in patients with colorectal pulmonary metastases who are not candidates for surgery," Dr. Glenn said.
Don Stewart, RITA's Chief Financial Officer, said lung cancer has been targeted as an important potential application of the RITA RF technology.
"Lung cancer has always been an important part of our planning as a
potential large application for our technology and this study significantly
advances the promising clinical data being accumulated toward that end,"
Stewart said.
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 and metastatic bone 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, 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. In October 2002, RITA again became the first company to receive specific FDA clearance, this time, for the palliation of pain associated with metastatic lesions involving bone. The Company has sold over 45,000 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. Information regarding these risks is included in the Company's filings with the Securities and Exchange Commission.
RITA and StarBurst are trademarks 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.
SOURCE RITA Medical Systems, Inc.