RITA Medical Acquires Exclusive U.S. and Canada Distribution Rights to the Biocompatibles LC Bead(TM) Embolization Product
27 4월 2006 - 8:30PM
PR Newswire (US)
Product Designed as a Minimally Invasive Treatment for
Hypervascularized Malignant Cancer Tumors FREMONT, Calif. and
FARNHAM, United Kingdom, April 27 /PRNewswire-FirstCall/ -- 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(R) 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
http://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 http://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. DATASOURCE: RITA Medical
Systems, Inc. CONTACT: investors, Doug Sherk, +1-415-896-6820, or ,
or Jennifer Beugelmans, +1-415-896-6820, or media, Steve DiMattia,
+1-646-277-8706, or ; or Stephen Pedroff, VP Marketing
Communications of RITA Medical Systems, Inc., +1-510-771-0400, or ;
or Crispin Simon, Chief Executive of Biocompatibles International,
+44-0-1252-732701, or Web site: http://www.biocompatibles.com/
http://www.ritamedical.com/
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