New Data Shows Rita Medical Systems RF Ablation Procedure
Dramatically Increases Liver Cancer Survival Rates
Procedure Provides New Hope for Patients
With Unresectable Liver Cancer and Colorectal Cancer
MOUNTAIN VIEW, Calif., Oct. 10 /PRNewswire-FirstCall/ --RITA Medical Systems, Inc. (Nasdaq: RITA) announced today that a new study on the use of its proprietary radiofrequency (RF) ablation technology on patients with unresectable primary or metastatic liver cancer showed that RF ablation increased median survival rates two- to three-fold compared to historical survival rates for patients treated with chemotherapy alone. The data from the 225-patient, six-center retrospective study of RF ablation were presented yesterday at the American College of Surgeons (ACS) Clinical Congress in San Francisco by lead investigator Allan Siperstein, M.D., of The Cleveland Clinic Foundation.
As many as 90 percent of the two million people worldwide each year who
have primary or metastatic liver cancer are not considered candidates for the
gold standard of surgical resection or are what is termed unresectable.
The patients in the study were unresectable liver cancer patients who were
treated with the RITA RF ablation procedure, often in addition to
chemotherapy. Three years after diagnosis, approximately 40-60 percent of the
patients were alive compared to the 10 percent who were alive without it.
Specifically, the Kaplan-Meier 1, 2, and 3-year survival rates for patients
with colorectal metastases were 95 percent, 79 percent and 60 percent, and for
primary liver cancer were 77 percent, 50 percent and 38 percent, respectively.
Patients with unresectable colorectal metastases or unresectable primary liver
cancer treated with chemotherapy alone historically have a 1-year survival of
approximately 50 percent, a 2-year survival of approximately 20 percent and a
3-year survival of approximately 10 percent.
Dr. Siperstein characterized the study as important news for a group of
liver cancer patients whose prognosis is otherwise rather bleak. He said that
chemotherapy is most often these patients' best choice, however, it works very
poorly in most liver cancer cases. This study demonstrates that
radiofrequency ablation is effective at significantly prolonging survival in a
very challenging group of patients with primary liver cancer, Siperstein
said. He also noted that the study showed the treatment is very effective in
prolonging life in another very important group of patients -- colorectal
cancer patients whose disease has spread, or metastasized, to the liver.
Spread of cancer to the liver occurs in nearly 60 percent of all patients with
colorectal cancer. While they may be responsive initially to chemotherapy,
in general, they will eventually die due to the progression of their tumors in
the liver. RF ablation dramatically improves their survival, he added.
RITA's RF ablation system enables physicians to deliver monitored and controlled levels of RF energy into the tissue through an array of thin electrodes that heat and destroy, or ablate, the targeted tissue. In many cases, this minimally invasive procedure can be performed with just local anesthesia.
Barry Cheskin, RITA's President and Chief Executive Officer, said that these clinical results have the potential to dramatically impact physicians' decisions on whether to use or recommend RF for their patients with unresectable liver tumors. For the majority of these patients, the diagnosis is dire, Cheskin said. While we have always been confident that our technology effectively destroyed tumors, we did not have clear data on its powerful impact on survival. This data offers hope to many patients who otherwise have few or no good alternatives.
The Company estimates that the worldwide market opportunity for its products in treating unresectable liver cancer is $500 million, in addition to other market opportunities of $600 million for treating painful bone metastases, $400 million for treating unresectable lung cancer and
$750 million for the treatment of uterine fibroids.
Other physicians and centers taking part in the study included Stanley J. Rogers, M.D., University of California, San Francisco; Junji Machi, M.D., Ph.D., University of Hawaii; Robert Goldstein, M.D., Baylor University; Earnest Rosato, M.D., Thomas Jefferson University and Timothy Sielaff, M.D., Ph.D., University of Minnesota.
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 approximately 40,000 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, any future impact of
survival data on physicians' decisions on whether to use or recommend RF for
their patients with unresectable liver tumors 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. Information regarding these and other risks is included in the
Company's filings with the Securities and Exchange Commission.
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.
RITA is a trademark of RITA Medical Systems, Inc.
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SOURCE RITA Medical Systems, Inc.
-0- 10/10/2002
/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/
/Web site: http://www.ritamedical.com /
(RITA)
CO: RITA Medical Systems, Inc.
ST: California
IN: MTC BIO
SU: SVY TDS
JN-GC
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5121 10/10/2002 07:30 EDT http://www.prnewswire.com