Rita Medical Highlights Recent Clinical Data Updating Study of Radiofrequency Ablation in the Treatment of Breast Cancer
October 11 2006 - 7:30AM
PR Newswire (US)
91% Reduction in Need for Re-Excision due to Inadequate Margins
Reported in Presentation at 92nd Annual Clinical Congress of the
American College of Surgeons FREMONT, Calif. and CHICAGO, Oct. 11
/PRNewswire-FirstCall/ -- RITA Medical Systems, Inc. (NASDAQ:RITA),
a publicly-traded medical device company focused solely on cancer
therapies, today highlighted the presentation of recently published
results of patient follow-up data after multimodal treatment for
breast cancer that included radiofrequency ablation (RFA).
Forty-one patients in the trial were treated with traditional
lumpectomy breast conserving surgical excision, followed
intraoperatively by radiofrequency ablation (eRFA). The authors
indicated that eRFA reduced the need for re-excision for inadequate
margins by 91% (10 of 11 patients with inadequate margins). On
October 10, 2006, at the 92nd Annual Clinical Congress of the
American College of Surgeons, in Chicago, Illinois, V. Suzanne
Klimberg, M.D., Professor of Surgery and Pathology at the
University of Arkansas for Medical Sciences presented the results
of a multiphase eRFA trial in an educational session entitled,
"Evolving Options in Breast Preserving Treatment of Breast Cancer
-- 'Percutaneous Excision and Ablation for Breast Cancers -- The
Future.'" Dr. Klimberg and her colleagues at the University of
Arkansas for Medical Sciences also reported on the findings of
their multiphase trial in an article titled, "eRFA: Excision
Followed by RFA - A New Technique to Improve Local Control in
Breast Cancer," peer-reviewed and published in the October 2006
issue of the Annals of Surgical Oncology. Dr. Klimberg commented,
"I believe eRFA represents an important area for further research
because of the potential patient benefits and the ease with which
it can be learned and practiced by the surgical community. Our
early results demonstrate that eRFA has the potential to reduce the
rate of re- excision due to positive or close margins, and provide
therapeutic outcomes potentially equivalent to brachytherapy in
favorable tumors, all with better cosmetic results for our
patients." Breast cancer is the most common cancer in women in the
U.S. In 2006, it is estimated that over 210,000 patients will be
diagnosed with breast cancer. One of the leading concerns in
patients who choose to have a lumpectomy procedure to remove a
tumor in the breast is to obtain a negative margin (tumor-free
zone) around the lumpectomy cavity to minimize the chance of local
tumor recurrence. Breast irradiation is often used as a follow-up
to prevent recurrence. However, inadequate margins are found at the
first operation in 20% to 55% of breast cancers removed by
lumpectomy. In addition, 75% to 90% of recurrences occur at the
site of the original lumpectomy. Joseph DeVivo, President and Chief
Executive Officer of RITA Medical Systems said, "Dr. Klimberg's
research is very encouraging in terms of demonstrating the
potential benefits of eRFA treatment in women who have received
lumpectomies in the treatment of their breast cancer." He
continued, "In the trial, eRFA provided safe margins around the
lumpectomy site, sparing patients from additional surgeries, which
we believe confirms the important role that RITA's RFA devices can
play in the treatment of breast cancer." eRFA: Excision Followed by
RFA -- A New Technique to Improve Local Control in Breast Cancer
(V. Suzanne Klimberg, M.D. et al, Annals of Surgical Oncology) The
multiphase trial, conducted at the University of Arkansas for
Medical Services from July 2002 to January 2005, included RFA of
prophylactic mastectomy specimens and RFA in patients desiring
lumpectomy. In both models, a lumpectomy was performed. The RFA
probe was deployed 1 cm circumferentially into the walls of the
lumpectomy cavity and maintained at 100 degrees C for 15 minutes.
Whole mount slides were used to measure the zone of ablation for
ex-vivo specimens. Forty-one patients with an average age of 63 and
an average tumor size of 1.6 cm participated in the study. Each
underwent in-vivo eRFA, and 25% (11 patients) had inadequate
margins. A finding of "inadequate margin" is made during the
post-surgery pathology examination of the lumpectomy specimen when
cancer cells are found close to the perimeter of the specimen,
indicating that additional cancer cells may remain in the
lumpectomy site. The ex-vivo ablation model for those who had
inadequate margins reliably created a 5-10 mm perimeter of
ablation. In-vivo, this 5-10 mm perimeter zone reduced the need for
re-excision for inadequate margins by 91% (10/11 patients). The
researchers conclude that short-term follow-up suggests that eRFA
could reduce re-excision surgery and local recurrence. V. Suzanne
Klimberg, M.D., is a professor of surgery and pathology at the
University of Arkansas for Medical Sciences (UAMS). UAMS and its
Arkansas Cancer Research Center are recognized nationally and
regionally for their commitment to advancing healthcare and cancer
treatment for patients. To view a copy of the study, please contact
the publisher, Springer New York. 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(R) 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
http://www.ritamedical.com/. The statements in this news release
related to the number of patients in the United States diagnosed
with breast cancer; the ability of eRFA treatment to reduce the
need for re-excision due to inadequate margins; the ability of eRFA
treatment to provide better cosmetic results; and the outcomes of
breast cancer patients treated with eRFA 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 ability to compete with
companies offering alternative therapies for solid cancerous and
benign tumors; the Company's ability to develop new radiofrequency
products; the Company's lack of long-term data regarding the safety
and efficacy of its radiofrequency products; delay of product
introductions or modifications as a result of the FDA regulatory
process; and the Company's success in its physician training
efforts. Information regarding these risks and other risks and
uncertainties is included in the Company's filings with the
Securities and Exchange Commission. DATASOURCE: RITA Medical
Systems, Inc. CONTACT: Stephen Pedroff, VP Marketing Communications
of RITA Medical Systems, Inc., +1-510-771-0400, or ; or investors,
Doug Sherk, , or Jenifer Kirtland, +1-415-896-6820, or media, Steve
DiMattia, +1-646-277-8706, or , both of EVC Group, for RITA Medical
Systems, Inc. Web site: http://www.ritamedical.com/
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