Multi-Center Clinical Study of Bone Cancer Patients Shows RITA Medical Systems RF Technology Dramatically Reduces Pain
Data from the study, which was conducted at nine centers in the United States, Italy, Germany and France, were presented by Matthew Goetz, M.D. on Monday at the 38th Annual Meeting of the American Society of Clinical Oncology (ASCO) held in Orlando. Dr. Goetz, a medical oncology fellow at Mayo Clinic, received ASCO's Merit award for this study. Dr. Goetz was part of a team of Mayo Clinic physicians involved in conducting the study, including William Charboneau, M.D., radiologist; Matthew Callstrom, M.D., radiologist; and Joseph Rublin, M.D., medical oncologist. Other centers involved in the study in the U.S. included Johns Hopkins Hospital, M.D. Anderson Cancer Center, Northwestern Memorial Hospital and St. Luke's Medical Center.
The study involved 43 patients with cancer that had spread or metastasized to the bone and who had either failed or were not eligible for conventional pain relieving treatments, including radiation and opioid analgesics. These patients were treated using RITA Medical Systems' RF ablation system. This system enables physicians to deliver monitored and controlled levels of RF energy into the tissue through an array of thin electrodes that heat and effectively destroy, or ablate, the targeted tissue. In many cases, this minimally invasive procedure can be performed in an outpatient setting or with just an overnight stay.
In this largest study ever conducted using RF for pain relief in metastatic bone tumors, 95 percent of the patients had a significant reduction in their pain. Patients were asked to report their pain on a standard 10-point pain rating scale before and after the procedure with 10 being pain 'as bad as you can imagine.' Of the 43 cancer patients enrolled in the study, 41 experienced a drop of two or more points in the severity of their pain after a single treatment. The majority of the 41 patients reported significant pain relief within the first week after their treatment and said the relief increased in subsequent weeks. More than 75 percent of patients experienced 90 percent or more pain relief at some point during the study. Follow-up on these patients indicates they continue to enjoy significant pain relief up to six months after their RF treatment.
"When patients were asked to report their worst pain, the average score before RF treatment was 7.9 out of 10," Dr. Goetz said. "After treatment, that score decreased to an average of 4.4 at four weeks and to 2.7 at 12 weeks post-treatment." According to Dr. Goetz, "The study provides further evidence that even the most challenging cancer pain can be effectively and safely controlled, and most importantly that patients whose cancer has spread to the bone may have a good quality of life."
Dr. Charboneau, senior investigator for this study at Mayo Clinic added, "With this study, we have extended the use of RF ablation from treatment of liver cancer to the treatment of pain from cancer that has spread to bone."
Barry Cheskin, RITA's President and Chief Executive Officer 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 from conventional therapies for the often intractable pain that accompanies it. Conventional therapies include chemotherapy, radiation or other drug therapies.
Cheskin added, "These results are a major step forward in our plans to commercialize the bone application in the fourth quarter of 2002. The data from this study form the basis of our 510(k) submission to the FDA, which is being submitted, as planned, this quarter. We are hoping that we will gain specific clearance for this application in the U.S. by the fourth quarter. We believe that this clearance has the potential to lead to additional revenue growth in the fourth quarter, helping us achieve our stated goal of profitability during that quarter."
The Company estimates that the worldwide market opportunity for its
products in treating painful bone metastases is $600 million, in addition to
other market opportunities of $500 million for treating unresectable liver
cancer, $400 million for treating unresectable lung cancer and $750 million
for the treatment of uterine fibroids.
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 expectations related to future sales and earnings, its expectations related to the receipt of specific FDA clearance for bone metastases, its 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 reliance on clinical data developed independently by third party physicians, 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: Matt Clawson (investors), matt@allencaron.com, or Len Hall (media), 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: Matt Clawson (investors), matt@allencaron.com, or Len Hall (media), 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