RITA Announces Launch of LC Bead(TM) Embolization Product in U.S.
2006年7月11日 - 8:30PM
PRニュース・ワイアー (英語)
Innovative Embolization Technology Used to Treat Cancerous Liver
Tumors FREMONT, Calif., July 11 /PRNewswire-FirstCall/ -- RITA
Medical Systems, Inc. (NASDAQ:RITA), a publicly-traded medical
device company focused solely on cancer therapies, today announced
the Company has begun sales of the LC Bead(TM) in the United
States. The new product is a minimally invasive embolization
treatment for hypervascular tumors that blocks the blood flow
feeding a tumor, causing it to shrink in size over time.
Embolization is commonly used to treat hepatocellular carcinoma,
the most common form of primary liver cancer, as well as
neuroendocrine tumors. "We completed our pre-marketing launch
activities for the LC Bead ahead of schedule and were even able to
begin shipping some of these products towards the end of the second
fiscal quarter. Our pre-marketing launch activities included
training our salesforce, placing the product into inventory at our
distribution center, and calling on current LC Bead customers to
ensure that the transition from the prior distributor went
smoothly," commented Joseph DeVivo, President and CEO of RITA. "We
are excited to bring this minimally invasive cancer treatment to
market through our integrated sales and marketing platform, which
remains solely focused on oncology medical devices. Our goal was to
launch the product in the third quarter and based upon this
success, recent feedback from the market, and the strength of our
tenured sales force, we are very excited about the potential of the
LC Bead products." The use of the LC Bead for the embolization of
hepatocellular carcinoma is reimbursed by Medicare and Medicaid.
Reimbursement includes approximately $1500 per procedure for
physicians and a Medicare national average of $6400 in facility
fees for each in-patient embolization procedure. The LC Bead is
cleared for the embolization of hypervascular tumors and
arteriovenous malformations in the United States by the U.S. Food
and Drug Administration (FDA). The product is distributed by RITA
from its U.S. operations center in Manchester, Georgia. RITA has an
exclusive three-year supply and distribution agreement with the
manufacturer of the LC Bead, United Kingdom-based Biocompatibles
International plc (LSE:BII), to market the product in the United
States and Canada. 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 distributes the LC Bead(TM)
(Biocompatibles, UK) product which is used in arterial embolization
of hypervascular tumors and arteriovenous malformations and has
U.S. Food and Drug Administration (FDA) marketing clearance in the
U.S. 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/. The statements in this news release
related to the commencement of sales of the LC Bead 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, , or
Jennifer Beugelmans, both at +1-415-896-6820, or media, Steve
DiMattia, +1-646-277-8706, or , all of EVC Group, for RITA Medical
Systems, Inc.; or Stephen Pedroff, VP Marketing Communications of
RITA Medical Systems, Inc., +1-510-771-0400, or Web site:
http://www.ritamedical.com/
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