-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, PLGJQPCG88NWCP+xs+pgPZxWMBj4/iql+9s+pGR6/Wd2wYIRpW5W21xCaV8rJ1ue 7MRaQ/70yb8J0AocF3INtQ== 0001144204-04-021913.txt : 20041216 0001144204-04-021913.hdr.sgml : 20041216 20041216132041 ACCESSION NUMBER: 0001144204-04-021913 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20041216 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20041216 DATE AS OF CHANGE: 20041216 FILER: COMPANY DATA: COMPANY CONFORMED NAME: RITA MEDICAL SYSTEMS INC CENTRAL INDEX KEY: 0001056421 STANDARD INDUSTRIAL CLASSIFICATION: ELECTROMEDICAL & ELECTROTHERAPEUTIC APPARATUS [3845] IRS NUMBER: 943199149 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-30959 FILM NUMBER: 041207471 BUSINESS ADDRESS: STREET 1: 967 N SHORELINE BLVD CITY: MOUNTAIN VIEW STATE: CA ZIP: 94013 BUSINESS PHONE: 6503858500 MAIL ADDRESS: STREET 1: 967 NORTH SHORELINE BLVD CITY: MOUNTAIN VIEW STATE: CA ZIP: 94043 8-K 1 v09983_8k.htm

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

Form 8-K

Current Report 

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

December 16, 2004
Date of Report
 (Date of earliest event reported)


RITA Medical Systems, Inc.
(Exact name of registrant as specified in its charter)

Delaware
(State or other jurisdiction of incorporation)

000-30959
94-3199149
(Commission File Number)
(I.R.S. Employer Identification No.)

967 N. Shoreline Blvd.
Mountain View, CA 94043
(Address of principal executive offices, with zip code)

(650) 314-3400
(Registrant's telephone number, including area code)



 
     

 


Item 8.01. Other Events and Required FD Disclosure.

On December 16, 2004, RITA Medical Systems, Inc., a Delaware corporation (“RITA”), announced publication of a peer reviewed article documenting improved survival rates for metastatic colorectal liver cancer patients treated with radiofrequency ablation. A copy of RITA’s press release announcing publication of the article is attached as Exhibit 99.1 hereto and incorporated by reference herein.



 
     




SIGNATURES


Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

     
  RITA Medical Systems, Inc.
 
 
 
 
 
 
Date: December 16, 2004 By:   /s/ Donald Stewart
 
Donald Stewart, Chief Financial Officer and
  Vice President Finance and Administration

 

 
     

 

RITA MEDICAL SYSTEMS, INC.

INDEX TO EXHIBITS


Exhibit Number
Description
 
     
99.1
Press Release of RITA Medical Systems, Inc. dated December 16, 2004.
 
     
     
     
     

     
EX-99.1 2 v09983_ex99-1.htm


 

       


Contact:
Allen & Caron Inc.
RITA Medical Systems, Inc.
 
Jill Bertotti (investors)
Don Stewart, Chief Financial Officer
 
jill@allencaron.com
Stephen Pedroff, VP Marketing Communications
 
949-474-4300
650-314-3400
 
SurfMedia Communications
dstewart@ritamed.com
 
Juliana Minsky (media)
spedroff@ritamed.com
 
jm@surfmedia.com
 
 
805-962-3700
     

PEER REVIEWED MEDICAL JOURNAL ARTICLE PUBLISHES IMPROVED SURVIVAL
RATES FOR METASTATIC COLORECTAL LIVER CANCER PATIENTS TREATED WITH RADIOFREQUENCY ABLATION

Researchers in Multicenter Trial Conclude RFA Combined with Chemotherapy Improves Patient
Outcomes for Metastatic Colorectal Liver Cancer

Mountain View, Calif., December 16, 2004, RITA Medical Systems, Inc. (Nasdaq: RITA) today announced that an article published in the November 2004 issue of Investigative Radiology reported improved long-term survival rates for 423 patients treated with radiofrequency ablation (RFA) for hepatic colorectal metastases. The article, “Percutaneous Radiofrequency Ablation of Hepatic Colorectal Metastases,” reports that RFA provided “substantially higher” long-term (5 year data) survival rates for patients who are not surgical candidates and who are treated with chemotherapy alone. Authors of the article concluded that RFA in combination with some form of chemotherapy is an effective way to improve survival outcomes in this patient population.
 
Riccardo Lencioni, M.D., Professor of Diagnostic and Interventional Radiology at the University of Pisa in Italy, and lead author of the article, commented, “The article is intended to provide interested clinicians with an overview of the data from the recently completed series of over 400 patients, as well as an historical review of the clinical data and experience treating colorectal liver cancer patients with radiofrequency ablation.” Dr. Lencioni continued, “Researchers concluded from the study that minimally invasive radiofrequency ablation should be considered a standard of care for limited hepatic metastatic disease from colorectal cancer when surgery is precluded.”
 
In the article researchers noted that 20% of colon cancer patients have evidence of liver metastases at the time they are diagnosed with the disease, and that 50% of all colon cancer patients will develop metastatic liver cancer during their treatment regimen. The article also notes that only 10% to 25% of metastatic liver cancer patients are candidates for surgical removal of tumors (resection).


MORE - MORE - MORE

 
     

 

COLORECTAL LIVER CANCER SURVIVAL DATA PUBLISHED
2-2-2

Joseph DeVivo, President and CEO of RITA Medical Systems, commented, “We believe that publication of this data in a peer reviewed journal is an important milestone in the future clinical acceptance of radiofrequency ablation for the treatment of colorectal liver cancer.” Mr. DeVivo continued, “Only lung cancer will cause more cancer deaths among men and women in the U.S. this year, and the researchers in this study estimate that half of all colon cancer patients will develop liver cancer. We continue to expect radiofrequency ablation to gain common application in this large patient population.”

“Percutaneous Radiofrequency Ablation of Hepatic Colorectal Metastases,” November 2004, Investigative Radiology, published data collected in a multicenter clinical trial in which 423 patients were treated. Patients accepted into the trial had been excluded or refused surgical treatment and had 4 or fewer tumors each less than 5 centimeters in size. A total of 615 tumors were treated using RITA Medical Systems radiofrequency electrodes. The primary effectiveness rate (percentage of tumors that were successfully eradicated following the planned treatment schedule) was 85.4% (525 of 615 lesions). The overall survival rate determined by the Kaplan-Meier1 method was 86% at 1 year, 63% at 2 years, 47% at 3 years, 29% at 4 years, and 24% at 5 years.

The American Cancer Society estimates that 147,500 Americans were diagnosed with colorectal cancer in 2003, and further estimates that the disease claimed more than 57,000 lives in 2003.2 The Company estimates that more than 70,000 colorectal cancer patients in the U.S. will develop colorectal metastatic liver cancer, and that more than 50,000 of these patients each year are candidates for RFA treatment. The Company estimates the total U.S. market opportunity for the treatment of colorectal liver cancer with RFA currently exceeds $100 million annually.

An abstract of the article is available on the Investigative Radiology website, www.investigativeradiology.com, by searching on the author’s name, or article title. The full text article is also available to interested parties for a fee at the same Internet address.
______________
1

For survival studies, the Kaplan-Meier estimate of survival is calculated by dividing time into intervals such that each interval ends at the time of an observation, whether censored (removed) or uncensored. The probability of survival is calculated at the end of each interval, with censored observations assumed to have occurred just after uncensored ones.

2 American Cancer Society, “Cancer Facts and Figures 2003”
.
About RITA Medical Systems, Inc.
RITA Medical Systems develops manufactures and markets innovative products for cancer patients including radiofrequency ablation (RFA) systems for treating cancerous tumors as well as percutaneous vascular and spinal access systems. The Company's oncology product lines include implantable ports, some of which feature its proprietary Vortex® technology; tunneled central venous catheters; safety infusion sets and peripherally inserted central catheters used primarily in cancer treatment protocols. The proprietary RITA system uses radiofrequency energy to heat tissue to a high enough temperature to ablate it or cause cell death. In March 2000, RITA became the first RFA 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.

MORE - MORE - MORE
 

 
     

 

 
COLORECTAL LIVER CANCER SURVIVAL DATA PUBLISHED
3-3-3

 
The statements in this news release related to the size of the United States market for the treatment of colorectal liver cancer, efficacy of RFA treatment, survival rates resulting from the use of RFA or the RITA System, and benefits of RFA treatment for colorectal liver cancer 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.
 

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-----END PRIVACY-ENHANCED MESSAGE-----