-----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, WV4us4ayjNLoHLLMUJ4HYFGVP+rMc7QzIfWrF0MBSqPlBjwvx+D+XLkYCNHOz49c zsq+wlY3a77F4W+VG/dJgQ== 0001193125-04-039025.txt : 20040311 0001193125-04-039025.hdr.sgml : 20040311 20040311141020 ACCESSION NUMBER: 0001193125-04-039025 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20040311 ITEM INFORMATION: Other events FILED AS OF DATE: 20040311 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: 04662547 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 d8k.htm FORM 8-K Form 8-K

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

 

March 11, 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 5. Other Events and Required FD Disclosure.

 

On March 11, 2004, RITA Medical Systems, Inc., a Delaware corporation (“RITA”), announced that Japan’s Ministry of Health, Labor and Welfare has approved reimbursement for the treatment of liver cancer with radiofrequency ablation, effective April 1, 2004. A copy of RITA’s press release announcing this release 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: March 11, 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 March 11, 2004.
EX-99.1 3 dex991.htm PRESS RELEASE Press Release

Exhibit 99.1

 

LOGO

 

Contact:

 

Allen & Caron Inc.

 

RITA Medical Systems, Inc.

   

Jill Bertotti (investors)

 

Don Stewart, Chief Financial Officer

   

949-474-4300

 

Stephen Pedroff, Marketing Communications

   

jill@allencaron.com

 

650-314-3400

   

Surf Media Communications

 

dstewart@ritamed.com

   

Juliana Minsky (media)

 

spedroff@ritamed.com

   

805-962-3700

   
   

jm@surfmedia.com

   

 

RITA MEDICAL SYSTEMS GRANTED JAPANESE REIMBURSEMENT APPROVAL

FOR ITS RADIOFREQUENCY ABLATION TREATMENT FOR LIVER CANCER

 

Japan Ministry of Health, Labor and Welfare Approves Reimbursement of

Radiofrequency Ablation Treatment for Liver Cancer Effective April 1, 2004

 

MOUNTAIN VIEW, CA (March 11, 2004) . . . RITA Medical Systems, Inc. (Nasdaq: RITA) today announced that the Japan Ministry of Health, Labor and Welfare (MHLW) has approved and established reimbursement for the treatment of liver cancer with radiofrequency ablation (RFA). The approval becomes effective on April 1, 2004, and sets reimbursement at JP136,000 Yen (approximately $1,200 U.S. dollars). The company markets the only MHLW approved radiofrequency ablation device in Japan.

 

The MHLW estimates that there are more than 34,500 new cases of primary liver cancer in Japan each year. The company estimates that the incidence of primary liver cancer in Japan is approximately six times the comparable rate in the United States. The company estimates that more than 60% of all primary liver cancer patients are amenable to RFA treatment of their tumors.

 

Mr. Joseph DeVivo, President and CEO of RITA Medical Systems stated, “With reimbursement now in place in Japan we expect an increase in the application of our technology to treat Japan’s liver cancer patients.” He continued, “At this time we are the only company selling in Japan with device and reimbursement approvals, and we expect to be a leading provider of radiofrequency ablation technology in this important market.”

 

“We believe that this reimbursement approval and recent long-term survival data for patients treated with RFA provides compelling reasons for Japanese clinicians to treat liver cancer patients with RFA,” Mr. DeVivo added.


MORE-MORE-MORE

 

Page 2-2-2

 

RITA became the first company to receive approval to treat liver cancer in Japan in 2002. The MHLW procedure clearance includes RITA’s 1500X Generator, and the Starburst and Starburst XL disposable electrodes. The company expects its Japanese distributor to begin placing re-orders for the company’s products in 2005.

 

Mr. John Soto, Vice President, International for RITA Medical Systems commented, “We expect utilization of disposable devices at our customer sites in Japan to increase and we expect to also see renewed interest from physicians and institutions in Japan not yet offering RFA treatment.” He continued, “The incidence of liver cancer in Japan is higher than in any other market the company now serves. With reimbursement in place we believe that Japan will be an important source of international revenue for RITA beginning in 2005.”

 

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 nearly 60,000 of its disposable devices throughout the world.

 

The statements in this news release related to the growth of international revenues, specifically in Japan, utilization of products in Japan, and the adoption of the company’s technology 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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