-----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, R245fm0uER/0u+2uNhqeD0OoyvyaNBaeN9aig/ce2wGz+HkYJJMu0hLrEAIBOe/q UvHfe9O/1nCkInveVYF4Uw== 0001144204-05-010403.txt : 20050404 0001144204-05-010403.hdr.sgml : 20050404 20050404172542 ACCESSION NUMBER: 0001144204-05-010403 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20050404 ITEM INFORMATION: Other Events FILED AS OF DATE: 20050404 DATE AS OF CHANGE: 20050404 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: 05731274 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 v015791_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

April 4, 2005
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 April 4, 2005, RITA Medical Systems, Inc. (Nasdaq: RITA) announced the introduction of the StarBurst TALON, a radiofrequency ablation (RFA) device that offers clinicians the ability to perform fast 4 cm spherical ablations with a novel side-deploy design that assists precise device positioning in tumors that may be mobile in soft tissue or adjacent to critical structures. A copy of RITA’s press release announcing this introduction 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: April 4, 2005 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 April 5, 2005.
 
 

EX-99.1 2 v015791_ex99-1.htm
 
 Contact:
Allen & Caron Inc.
Jill Bertotti (investors)  
jill@allencaron.com
949-474-4300
SurfMedia Communications
Juliana Minsky (media)  
jm@surfmedia.com
805-962-3700
RITA Medical Systems, Inc.
Don Stewart, Chief Financial Officer
Stephen Pedroff, VP Marketing Communications
650-314-3400
dstewart@ritamed.com
spedroff@ritamed.com
   
NEW TALON™ RADIOFREQUENCY ABLATION DEVICE FOR PERIPHERALLY LOCATED TUMORS INTRODUCED BY RITA MEDICAL SYSTEMS AT SOCIETY OF INTERVENTIONAL RADIOLOGY ANNUAL SCIENTIFIC MEETING
 
Novel StarBurst™ TALON Radiofrequency Electrode Creates Fast 4 cm Spherical Ablations
 
MOUNTAIN VIEW, Calif., April 4, 2005 -- RITA Medical Systems, Inc. (Nasdaq: RITA) today announced the introduction of the StarBurst TALON, a radiofrequency ablation (RFA) device that offers clinicians the ability to perform fast 4 cm spherical ablations with a novel side-deploy design that assists precise device positioning in tumors that may be mobile in soft tissue or adjacent to critical structures. The new TALON side-deployed electrode was introduced at the 30th Annual Scientific Meeting of the Society of Interventional Radiology (SIR), March 31 - April 5, 2005, in New Orleans. The TALON delivers an easy to use product solution for non-staged deployed ablations compatible with the company’s infusion system family of products that use the Intelliflow™ pump to deliver precise amounts of saline to the ablation site.
 
The TALON electrode, now available for sale in the United States and Europe, builds on RITA Medical’s considerable clinical experience in local control of cancerous tumors using radiofrequency ablation. TALON is cleared by the U.S. Food and Drug Administration for use in partial or complete ablation of non-resectable liver lesions and the palliation of pain associated with metastatic lesions in patients who have failed or are not candidates for standard therapy. The TALON is labeled with the CE Mark for distribution in Europe.
 
Joseph DeVivo, President and CEO of RITA Medical Systems, commented, "We believe the TALON device performs the fastest 4 cm ablation clinically available today, and we intend to market it as the product of choice for surgical oncologists and interventional radiologists who want a fast and easy 4cm ablation for central and difficult to access lesions.” Mr. DeVivo continued, "As the competitive landscape focuses on fast, easy ablations, we expect the TALON device to become a market leader.”
 
MORE - MORE - MORE
 

 
The Starburst Talon may be used in laparoscopic, percutaneous or open procedures and includes several novel usability features.
 
-  
Fast 4 cm spherical ablation possible in as little as 9 minutes after reaching the target temperature using the RITA Infusion System and Intelliflow™ pump.
 
-  
A unique tapered cutting tip center electrode to make it easier to penetrate solid tumors.
 
-  
Easy to position for both surface and difficult to reach dome lesions.
 
-  
Semi-flexible 900 bendable version available (TALON Semi-Flex™) that makes entry into CT (Computed Tomography) imaging gantry possible without sacrificing electrode penetration depth.
 
-  
Proprietary real-time temperature feedback from all four electrode tines ensures controlled ablation
 
RITA Medical products have been used in more than 75,000 ablation procedures. Radiofrequency ablation allows physicians to deliver radio frequency electrodes directly into cancerous tumors through a thin probe. The electrodes are commonly introduced in a minimally invasive manner to heat and effectively destroy, or ablate, the targeted area. RITA RF ablation is performed on patients with tumors of the liver, bone, and soft tissue, and is normally used in conjunction with chemotherapy, or radiation treatments.
 
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. The RITA Medical Systems website is at www.ritamedical.com.
 
The statements in this news release related to the performance of the new Starburst Talon, physician adoption of the Starburst Talon, and the technological achievements of the Starburst Talon, 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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