-----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, JmgaoZeHmW4QVikc8V/6EZfCA/e16RMykdGrwT3SvvQAvB1r3DO/SfV1ranS1/Se 6mrMbkTwVCHl6z19v0BZZg== 0001193125-04-083645.txt : 20040510 0001193125-04-083645.hdr.sgml : 20040510 20040510160545 ACCESSION NUMBER: 0001193125-04-083645 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20040510 ITEM INFORMATION: Other events FILED AS OF DATE: 20040510 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: 04793230 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

 

May 10, 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 May 10, 2004, RITA Medical Systems, Inc., a Delaware corporation (“RITA”), announced that clinical investigators at the University of Texas Southwestern Medical Center in Dallas, Texas presented their paper titled, “Laparoscopic Radiofrequency Ablation of Small Renal Tumors,” at the American Urology Association annual scientific meeting in San Francisco, California. Investigators reported that initial ablation was successful in 40 out of 41 tumors (98%) at a mean follow-up of 16.1 months. 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: May 10, 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 May 10, 2004.
EX-99.1 2 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

    

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

    

 

CLINICAL STUDY DEMONSTRATES CANCER TREATMENT USING RITA MEDICAL

SYSTEMS RADIOFREQUENCY ABLATION PRODUCTS 98% EFFECTIVE FOR SMALL

KIDNEY TUMORS

 

Article Presented at 2004 American Urology Association Annual Meeting in San Francisco

Reports 98% Success Rate in 33 Patient Study Treating 41 Tumors

 

Mountain View, Calif., May 10, 2004, RITA Medical Systems, Inc. (Nasdaq: RITA) today announced that clinical investigators at the University of Texas Southwestern Medical Center in Dallas, Texas presented their paper titled, “Laparoscopic Radiofrequency Ablation of Small Renal Tumors,” at the American Urology Association annual scientific meeting in San Francisco, California. Investigators reported that initial ablation was successful in 40 out of 41 tumors (98%) at a mean follow-up of 16.1 months.

 

Jeffrey A. Cadeddu, M.D., a member of the clinical investigation team and Director, Clinical Center for Minimally Invasive Urologic Cancer Treatment at the University of Texas Southwestern, commented, “Our intention was to demonstrate that radiofrequency ablation can successfully treat patients with small kidney tumors who require a laparoscopic approach while sparing as much kidney function as possible. The early results indicate that the procedure provides excellent control of the cancer.”

 

Dr. Cadeddu continued, “We hope to continue to follow these patients, and to expand our experience to additional patients. We believe that radiofrequency ablation to treat tumors while protecting kidney function will become an important tool for urologists going forward.”

 

Investigators treated 41 tumors in 33 patients with small renal tumors using RITA Medical Systems’ radiofrequency ablation (RFA) products. The authors concluded that laparoscopic RFA is feasible for tumors that may not be amenable to a percutaneous approach, and that cancer control appeared adequate in the patients followed to date.

 

Mr. Joseph DeVivo, President & CEO of RITA Medical commented, “We believe Dr. Cadeddu and his associates are the first to present such compelling clinical evidence to support the use of radiofrequency ablation in the treatment of kidney cancer. We applaud the efforts of his team and we continue to pursue the necessary regulatory clearances to ensure widespread adoption of the procedure by other clinicians in the United States.”

 

MORE-MORE-MORE


RADIOFREQUENCY ABLATION FOR KIDNEY CANCER

2-2-2

 

The company estimates that 78,000 patients worldwide are diagnosed each year with kidney cancer and that approximately 18% of these cases, or 14,220 patients, will be found to be amenable to radiofrequency ablation to control their tumors.1

 

An abstract of the article presented at the AUA Annual Meeting is available on the American Association of Urology website, http://aua04.agora.com/lookup/. Enter Dr. Cadeddu’s name in the search field, or enter the title of the article, “Laparoscopic Radiofrequency Ablation of Small Renal Tumors.”

 

Contributing authors of the article include Edward D. Matsumoto, M.D., Fellow of the Dept. of Urology, University of Texas Southwestern Medical Center in Dallas, Texas, Devin B. Johnson, M.D., Assistant Professor, Dept. of Urology, University of Utah Health Sciences Center, and Kenneth Ogan, M.D., Assistant Professor, Dept. of Urology, Emory University School of Medicine.

 

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


1 De Vita, Cancer Principles and Practice of Oncology, Lippincott, Williams and Wilkins, 6th Edition, 2001

 

The statements in this news release related to the results of studies, the use of the Company’s technology, its expectations regarding doctors’ adoption of the technology, and its expectations regarding the extension of its technology to applications beyond the liver 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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