Data Show RITA Medical Systems Radiofrequency Technology Effective In Treating Uterine Fibroids

May 8, 2002 at 12:00 AM EDT
Data Show RITA Medical Systems Radiofrequency Technology Effective In Treating Uterine FibroidsMOUNTAIN VIEW, Calif., May 8 /PRNewswire-FirstCall/ -- RITA Medical Systems, Inc. (Nasdaq: RITA) announced today that the results of a retrospective case series on the use of its proprietary radiofrequency (RF) ablation technology show the minimally invasive procedure appears to be effective in treating uterine fibroids, which are benign tumors of the uterus. Data from the study, which was conducted at the Monterey Peninsula Surgery Center in Monterey, CA, was presented by its lead investigator Bruce B. Lee, M.D. on Tuesday at the American College of Obstetricians and Gynecologists (ACOG) 50th Annual Clinical Meeting, held in Los Angeles May 4th to 8th. Dr. Lee is Director of Gynecologic Surgery at the Monterey Center.

Uterine fibroids are the most common tumor found in women, causing symptoms which may include severe pain and excessive menstrual bleeding in approximately 15 million women in the U.S. alone. Current therapeutic options for this condition are very limited. One of the most common is a hysterectomy, with approximately 200,000 fibroid-related hysterectomies being performed in the U.S. each year. However, only a minority of women elect this invasive procedure.

The retrospective study involved 58 patients with 218 fibroids. These patients were treated using RITA Medical Systems' radiofrequency ablation system. This system enables physicians to deliver monitored and controlled levels of radiofrequency energy into the tissue through an array of thin electrodes which 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.

The results showed that resolution of the symptoms caused by fibroids occurred in as many as 100 percent of patients followed for at least twelve months. There were no major complications. Specifically, symptom resolution occurred for 100 percent of patients who had experienced pressure pain, 100 percent for those with increased urinary frequency, 92 percent for those with dyspareunia (pain during intercourse), 90 percent for those with mennorhagia (excessive menstrual bleeding) and 82 percent for those with dysmenorrhea (painful menstruation). The mean follow-up time for the patients in the study was 10.9 months (range 1-25 months).

"My opinion is that RF ablation offers uterine fibroid patients excellent outcomes," Dr. Lee said. "In an overwhelming majority of my patients, RF ablation brought about dramatic improvement or even complete resolution of their symptoms. From my vantage point, this is a real win for patients, who can quickly get back to their normal lives after the procedure, feeling much better."

Barry Cheskin, RITA President and Chief Executive Officer, commented, "Women facing a diagnosis of uterine fibroids today are in an unenviable position. They are generally left with the option of undergoing a hysterectomy, an invasive surgical procedure, or living with this sometimes debilitating condition. We believe that the RITA procedure could provide a viable alternative for a large number of these woman and could result in a dramatic improvement in their quality of life."

Cheskin added that while more research is needed, the presentation of the study represents a major milestone for the Company, "validating RITA's technology in yet another clinical application that we believe will represent a major market opportunity for the Company in the future."

The Company estimates that the worldwide market opportunity for its products in treating uterine fibroids is $750 million, in addition to other market opportunities of $500 million for treating unresectable liver cancer, $400 million for treating unresectable lung cancer and $600 million for the treatment of painful bone metastases.

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 plans to extend its technology to applications beyond the liver and the 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),, or Len Hall (media),, 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,

SOURCE RITA Medical Systems, Inc.
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CONTACT: Matt Clawson (investors),, or Len Hall (media),, 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,