Healthcare Industry News: peripherally inserted central catheter
News Release - October 17, 2006
RITA Medical Systems Announces FDA 510(k) Clearance of HABIB 4X Laparoscopic(TM) DeviceCompany Expects to Begin Shipping Product in the Second Half of the Fourth Quarter of 2006
FREMONT, Calif., Oct. 17 (HSMN NewsFeed) -- RITA Medical Systems, Inc. (Nasdaq: RITA ), a publicly-traded medical device company focused solely on cancer therapies, today announced that the HABIB 4X Laparoscopic(TM) resection device received 510(k) marketing clearance from the U.S. Food and Drug Administration (FDA).
Anticipated commencement of sale of the new product continues to be ahead of schedule, as reported in the Company's second quarter 2006 earnings conference call. The Company expects to make first domestic shipments of the product to its customers in the second half of the fourth quarter of 2006. The Company expects to complete CE mark certification so that sales of the product in Europe may begin at the same time product begins shipping in the U.S.
Joseph DeVivo, President and CEO of RITA Medical, commented, "The laparoscopic version of the Habib 4X device was developed in direct response to demands from our surgeon customers who are dedicated to providing the benefits of minimally invasive surgical techniques to their patients. We are particularly proud of the fact that the device was developed entirely in-house, and that we will manufacture the device at our Manchester, Georgia facility."
Mr. DeVivo continued, "Introduction of the laparoscopic Habib represents another critical milestone in the execution of our long-term strategy to offer our customers valuable and novel technology to treat a wide range of patients with cancer. We expect that the laparoscopic product launch will occur during the fourth quarter and will continue the positive momentum the Habib 4X has developed in the marketplace."
The Habib 4X Laparoscopic resection device coagulates a surgical resection plane to facilitate a fast dissection with limited blood loss. The Company believes this technology will be utilized in a variety of cancer surgeries, including liver and kidney, as it is designed to minimize blood loss and blood transfusion during resection. Additionally the Habib 4X Laparoscopic resection device is designed to work on the current RITA RFA platform of 1500X(TM) Generators.
The HABIB 4X Laparoscopic resection device is intended to be used to assist in coagulation of tissue during intraoperative and laparoscopic surgical procedures.
The Company has been selling the Habib 4X(TM) Resection Device since the third quarter of 2005. The new HABIB 4X Laparoscopic resection device incorporates technology licensed by RITA Medical Systems, Inc. from United Kingdom based EMcision Limited. "Habib" is a licensed trademark of EMcision Limited.
About RITA Medical Systems, Inc.
RITA Medical Systems develops, manufactures and markets innovative products for cancer patients including radiofrequency ablation (RFA) systems and embolization products 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 radiofrequency 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 Company also distributes LC Bead embolic microspheres in the United States. The LC Bead microspheres are injected into selected vessels to block the blood flow feeding a tumor, causing it to shrink over time, and are often used in combination with radiofrequency ablation (RFA). The RITA Medical Systems website is at www.ritamedical.com.
The statements in this news release related to the introduction of the HABIB 4X Laparoscopic resection device in the second half of the fourth quarter of 2006; that the laparoscopic version of the HABIB 4X resection device will continue the positive momentum the product has developed in the marketplace; the performance of the HABIB 4X Laparoscopic resection device; and physician adoption of the HABIB 4X Laparoscopic Resection device 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 risk of product defects, recalls or failures; potential product delays caused by unforeseen manufacturing challenges; reliance on a small number of suppliers for components of the HABIB 4X Laparoscopic resection device; compliance with FDA regulations; and physician training efforts. Information regarding these risks is included in the Company's filings with the Securities and Exchange Commission.
Source: RITA Medical Systems
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