Healthcare Industry News: peripherally inserted central catheter
News Release - April 27, 2006
RITA Medical Acquires Exclusive U.S. and Canada Distribution Rights to the Biocompatibles LC Bead(TM) Embolization ProductProduct Designed as a Minimally Invasive Treatment for Hypervascularized Malignant Cancer Tumors
FREMONT, Calif. and FARNHAM, United Kingdom, April 27 (HSMN NewsFeed) -- RITA Medical Systems, Inc. (Nasdaq: RITA ) a publicly traded company focused solely on cancer therapies, today announced the signing of an exclusive three-year supply and distribution agreement with United Kingdom-based Biocompatibles International plc (LSE: BII ) to market its LC Bead embolization product in the United States and Canada. The product is designed as a minimally invasive treatment for hypervascular tumors. The LC Bead microspheres are injected into selected vessels to block the blood flow feeding a tumor, causing it to shrink over time, and is often used in combination with radiofrequency ablation (RFA). Embolization is commonly used to treat a number of conditions, including hepatocellular carcinoma, the most common form of primary liver cancer, and neuroendocrine tumors.
RITA believes that the total potential U.S. and Canadian market for all embolization products may be up to $50 million annually, based primarily on the use of embolization in primary liver cancer patients. RITA currently expects to begin shipments of the LC Bead in the third quarter of 2006.
"We believe the LC Bead is the technology of choice in this emerging field of medicine," said Joseph DeVivo, President and CEO of RITA Medical Systems. "This minimally invasive treatment for cancer fits closely with our existing product offerings and with our position as an outstanding medical device oncology company providing real value to doctors and their patients. Based upon our relationships within the interventional radiology community, and the potentially complementary nature of this technology with our core RFA technology, we believe our existing sales force will be able to successfully introduce this product to the U.S. market." He continued, "We are very pleased to partner with Biocompatibles, whom we believe to be a world leader in the development of micro-infusion therapies."
"We believe we have found the right partner in RITA Medical for U.S. and Canadian distribution of the LC Bead," said Crispin Simon, Chief Executive of Biocompatibles International. He continued, "We share RITA's vision of device-based therapies playing an expanding role in the treatment of cancer. Our common goal is to make cancer therapy both more effective and less traumatic for patients. We chose RITA because of their intense focus on the introduction of novel medical device oncology technology and their ability to influence physicians who will ultimately drive the clinical adoption of embolization."
The LC Bead is cleared for use in embolization of hypervascular tumors and arteriovenous malformations in the United States by the U.S. Food and Drug Administration (FDA). The product will be distributed by RITA from its U.S. operations center in Manchester, Georgia.
"The use of embolization to treat liver cancer is very synergistic with RITA's current surgical and RFA products: where radiofrequency works by destroying the tumor from the inside out, embolization works from the outside in," said Jelle W. Kylstra, MD, Vice President and Medical Director of RITA Medical Systems. "Many patients currently receive both treatments. Where some clinicians use trans-arterial chemo-embolization (TACE) at the periphery of large tumors following RFA, others are using TACE prior to RFA as a means of obstructing blood flow into the tumor, with the goal of enhancing the speed and size of subsequent RFA."
The LC Bead is used as the embolic component of a procedure known as trans-arterial chemo-embolization (TACE). TACE has been demonstrated in clinical trials to reduce the size of liver tumors, enabling some patients to receive further treatment with surgery, RFA or a curative liver transplantation. TACE is used in the treatment of hypervascular tumors, including certain liver tumors, and combines tumor-directed chemotherapy with embolization therapy. During a chemo-embolization or TACE procedure, a chemotherapy drug is mixed with an embolization agent like the LC-Bead. The mixture is injected into the blood vessels feeding the tumor. TACE aims to reduce the blood supply to the tumor while simultaneously delivering a high local dose of chemotherapy.
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.
About Biocompatibles International plc
Biocompatibles International plc is the medical technology company focused on drug device Combination Products for use in oncology and cardiology. Biocompatible International's proprietary biomedical polymer systems provide medical devices with enhanced biocompatibility and offer a platform for drug delivery. Further information is available at www.biocompatibles.com.
The statements in this news release related to the size of the United States and Canada market for embolization products; the commencement of sales by RITA in the third quarter of 2006; RITA's ability to market and sell the LC Bead product using its existing sales force, including its ability to meet its minimum purchase requirements; and physician adoption of the LC Bead product are forward-looking statements involving risks and uncertainties that could cause actual results to differ materially from those is such forward-looking statements. Such risks and uncertainties include but are not limited to: compliance with FDA regulations; competitive pressures; physician training efforts; RITA's historical and future operating results and profitability; 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
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