RITA Medical Resumes Volume Shipments of HABIB(TM)4X Resection Device
Following the September 2005 receipt of isolated reports that the sterile packaging of some HABIB 4X products sold to U.S. customers had been compromised during shipping, the Company announced on September 27, 2005 that it would delay domestic shipment of the product and request the return of all such products previously shipped. Subsequent to that announcement, the Company successfully worked with the registered product manufacturer to implement package design improvements.
"We are delighted to have resumed volume shipments of the HABIB 4X resection device on schedule," said Joseph DeVivo, President and CEO of RITA Medical. "Our field sales staff reports that during the past week the product has been used successfully in cases throughout the United States. We are now focused on executing the complete launch of the product and delivering on our sales expectations for the quarter," he concluded.
The HABIB 4X resection device received 510(k) U.S. marketing clearance from the U.S. Food and Drug Administration (FDA) in August 2005, and is also labeled with the CE Mark for distribution in Europe. The device is designed to be used in surgical procedures for the resection of tissue and includes the following features:
-- Bi-polar electrode device designed for fast tissue ablation and coagulation
-- Automatic operation with RITA 1500X Generator software upgrade
-- Designed to minimize blood loss during surgical tissue resection
-- Designed to reduce costs associated with resection procedures
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; and safety infusion sets and peripherally inserted central catheters used primarily in cancer treatment protocols. The product line also includes the HABIB 4X resection device, which coagulates a "surgical resection plane" and is designed to facilitate a fast dissection in order to minimize blood loss and blood transfusion during surgery. The proprietary RITA RFA 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 packaging design for the HABIB 4X Resection device, physician adoption of and demand for the HABIB 4X Resection device, the performance and technological achievements of the HABIB 4X Resection device, the availability of the device for shipment to customers worldwide, and the Company's ability to deliver its sales expectations for the quarter, are forward-looking statements involving risks and uncertainties that could cause actual results to differ materially from those in such forward-looking statements. Such risks and uncertainties include but are not limited to: the Company's dependence on one third-party manufacturer for the supply of the HABIB 4X resection device; the Company's historical and future operating results and profitability; market acceptance of the Company's products for existing or new indications; the Company's dependence on international sales; competitive pressures; the ability of users of the Company's products to receive reimbursement from third-party payors, governmental programs or private insurance plans; and general economic and political conditions. Information regarding these risks is included in the Company's filings with the Securities and Exchange Commission.
SOURCE RITA Medical Systems, Inc.
-0- 11/15/2005
CONTACT: investors, Doug Sherk, dsherk@evcgroup.com, or Jennifer
Beugelmans, both at +1-415-896-6820, or media, Steve DiMattia,
+1-646-277-8706, or sdimattia@evcgroup.com, all of EVC Group, for RITA Medical
Systems, Inc.; or Stephen Pedroff, VP Marketing of RITA Medical Systems, Inc.,
+1-510-771-0400, or spedroff@ritamed.com
Web site: http://www.ritamedical.com
(RITA)