(OTC Bulletin Board: PWRM), a leading proteomics company, today
announced that
to date, it has enrolled 137 participants from three
participating locations -- the Clinical Research
Center of Houston,
Obstetrical and Gynecological Associates (OGA), Mercy Women's Center in
Oklahoma
City and NYU Medical Center -- in its multi-site clinical validation
study for the early detection
of breast cancer.
CONTACTS:
Corporate Investor Relations
Steven Rash Kathy Price
Chairman/CEO
Managing Director
Power3 Medical Products, Inc.
Health Canada approved commercial
sale of the ATEC(R) system for use in
performing diagnostic breast biopsy and partial or complete
removal of visible
evidence of benign breast disease. Vanel used the DOBI Medical ComfortScan system
as a
key element of his study.
fibrocystic stereotaxic
Rash, Chairman
and CEO of Power3. The
Company operates a state
-of-the-art proteomics laboratory in The Woodlands,
Texas.SurosSurgical.
S.mammary radiologyinfo
Previous
studies by Power3 Medical using proteomic analysis of NAF and
blood serum have identified differences
in the protein patterns of women with
breast cancer, women of high risk for the disease, and normal
women with no
diagnosed breast cancer.
"Power3 recently filed applications with the United
States Patent and
Trademark Office for the NAF Test and its constituent biomarkers, and we
recently
entered into a licensing agreement with a leading bio-medical company
to commercially develop this
breast cancer technology. "Until now, many centers using MRI to detect lesions needed
to perform
the biopsy through surgery. vacuum assisted breast biopsy (VABB) market and has the
largest contingent
of field representatives with more than 50 sales and
clinical applications professionals.
The
Institute Gustave-Roussy is a non-profit private institution,
exclusively devoted to oncology and
is one of the premiere cancer
treatment centers in Europe. Certain of
these risks, uncertainties
, and other factors are described in greater
detail in our filings from time to time with the U. Subsequent
written and oral
forward-looking statements attributable to us or to persons acting on
our behalf
are expressly qualified in their entirety by the cautionary
statements set forth above and elsewhere
in our reports filed with the
U.S.mammograms abnormality
"When we know that most
biopsy results are benign, having women
go through unnecessary surgery is just
crazy. "We've found that the breast care market seeks and
rewards
clinically relevant innovation, and that's what continues to drive our
growth.European
Journal of Radiology Article Discusses DOBI Medical's ComfortScan System's Potential as an Adjunctive
Breast Cancer Diagnostic Tool
DOBI Medical International's
first application of the technology
is the ComfortScan system, a
gentle, noninvasive, and non-ionizing, optical imaging system designed
to assist physicians in the detection and management of breast cancer. Such forward-looking
statements
involve known and unknown risks, uncertainties, and other
factors, including without limitation,
those relating to our ability
to timely and successfully complete our patient clinical trials; our
ability to timely and successfully complete and submit our premarket
approval application to the
FDA; the timely and final approval by the
FDA of our ComfortScan system as a adjunct to mammography
, which
approval in the U.diti stereotaxic
"Our strategic position is to focus on both NAF and blood
serum biomarkers
that together appear to provide a highly sensitive and
specific indication of breast cancer.com,
is a leading
proteomics company engaged in the discovery of protein footprints, pathways,
and
mechanisms of diseases."
About the Trial
In the 25-patient study, patients underwent both
breast MRI and
optical scans in addition to standard mammography and ultrasonography. Forward-looking
statements are frequently accompanied by the
use of such words as "anticipates," "plans," "believes
," "expects,"
"projects," "intends," and similar expressions.cysts mastitis
THE WOODLANDS, Texas, Power3 Medical
Products, Inc. We continue to make
progress towards the validation of the NAF test and plan to
expand our
intellectual property and biomarker portfolio," concluded Mr. Expansion Gives New
Option to More Than 140,000 Canadian Women
Requiring Breast Biopsy
INDIANAPOLIS, Medical device maker Suros Surgical
Systems, Inc., of the radiology department
at the Institute
Gustave-Roussy in Villejuif, France, entitled "Dynamic Optical Breast
Imaging
(DOBI): A New Technique to Visualise Breast Vessels:
Comparison with Breast MRI and Preliminary Results
," was published
this month in a special breast cancer edition of the European Journal
of Radiology
. The ComfortScan system is not yet commercially
available as an adjunct to mammography in the U. and
foreign medical device quality regulation standards required
to maintain our CE Mark and our ISO
, UL and FDA export certifications;
our ability to timely deliver our products into international
markets;
the acceptance and use of our ComfortScan system by physicians,
imaging clinics, and
patients; and our ability to obtain third party
reimbursement from U.
Any one of these or other
risks, uncertainties, other factors, or
any inaccurate assumptions may cause actual results to be
materially
different from those described herein or elsewhere by us.S.diti radiologyinfo
The
company designs, manufactures
and markets patient-focused and physician-
inspired "Compassionate Technologies" through its ATEC
(R) (Automated Tissue
Excision and Collection) product line compatible with stereotactic, ultrasound
and magnetic resonance imaging (MRI) systems.OB) announced today that an article authored by
Daniel
Vanel, M. Securities and Exchange Commission.biopsy prosthetics
The NAF fluid and blood serum samples are collected
at the three clinical
sites and shipped to Power3 for analysis, using proprietary technologies that
monitor a select group of breast cancer related protein biomarkers. Words such as
"will," "expects
," "anticipates," "plans," and similar expressions are
intended to identify these forward-looking
statements. Until now, physicians had only one primary
device option for vacuum assisted breast biopsy
using the most common image
guidance method of stereotactic (two dimensional x-ray imaging used in
traditional mammography). Ellen Warner, medical
oncologist with Sunnybrook and Women's College
Health Sciences Center in
Toronto, Ontario." Sunnybrook is the leading MRI research center in Canada
and is
considered a Center of Excellence by Suros. Additional studies with the ComfortScan system
are slated for later this later year. law to investigational use until approved by the FDA, which
cannot be guaranteed. S.S.
Products for sale are listed under Shopping/Health_and_Beauty/Women
/
stereotaxic abnormality
Suros currently holds more
than 10% of the U. For more information about Suros and the ATEC(R
) family of
products, go to http://www.com . as it is limited by
U. and
foreign government laws
and industry standards; our ability to meet
U. We caution
readers not to place undue reliance
on any such forward-looking
statements, which speak only as of the date they were made.saline sclerosing
The validation
study involves
the collection of nipple aspirate fluid (NAF) and blood serum samples from
several
hundred women.
This press release contains "forward-looking" statements, including
statements
related to the commercial development of Power3's products and
associated development activities
. There are a number of
important factors and uncertainties that could cause results to differ
materially
from those indicated by these forward-looking statements, including
risks inherent in research and
development activities; the ability to raise
sufficient capital and obtain financing for the development
activities;
uncertainties associated with regulatory approvals; as well as other risks
detailed
from time to time in Power3's reports filed with the Securities and
Exchange Commission, including
its Annual Report on Form 10-KSB for the year
ended December 31, 2003, and its reports on Form 10
-QSB and Form 8-K."
Suros is considered the innovator and pioneer of vacuum assisted breast
biopsy
using MRI guidance, with more than 160 facilities now using the ATEC(R)
system with MRI exclusively
. Since becoming available in 2001, the ATEC(R) breast biopsy
system has been installed in more than
400 hospitals and breast centers across
North America and more than 80,000 procedures have been successfully
performed.
For more information on DOBI Medical or the ComfortScan system,
visit www.cysts prosthetics
Power3
Medical Updates Its Breast Cancer Validation Studies at Three Sites
Power3
assumes no obligation
to update forward-looking statements as a result of new
information, future events or otherwise.
The Anne McBride Company
Tel: 281-466-1600 Tel: 212-983-1702
x212
Results
ComfortScan system images were positive in four of the five cases
where MRI was positive. Investigators noted that they
found the potential advantages of ComfortScan
system imaging included
the ease of patient positioning, quick exam time, and the absence of
ionizing
(X-ray) radiation.
DOBI Medical is a microcap, developmental stage, medical imaging
company
working to create a new means for the improved diagnosis of
cancer through the detection of abnormal
vascularization
("angiogenesis") associated with tumors.benign abbi
The Company provides no assurances that
it
will submit an IDE application or that any IDE application will be approved by
the FDA.Suros
Wins Approval to Sell Breast Biopsy System in Canada
J. and foreign government and private payers
.breast mammography
The good news is that a test based on
proteomics -- the study and analysis of multiple proteins
-- may be able to
show whether a patient has breast cancer years prior to mammography,
indicating
the need for more aggressive imaging with ultrasound or MRI. Adding ATEC(R) users in Canada to its
growing
customer base is part of the Suros three-pronged expansion strategy
that includes expanding geographic
boundaries, increasing staff size, and
continuing to develop new and innovative products. Suros is
viewed worldwide as the
pioneer and market leader in vacuum-assisted MRI-guided breast biopsy
technology
. "The sensitivity of
the ComfortScan system technology was extremely strong and the
specificity
rates also were positive.com.Information about breast disorders from pain to cysts.
radiologyinfo pollutants
About
Power3 Medical Products
Power3 Medical Products, http://www. The Company's patent-pending technologies
are
being used to develop screening and diagnostic tests for the early detection
and treatment
of disease. Tissue acquisition can be completed in 30 seconds, reducing
total procedure time.stereotaxic imaginis
S.
S. Compatibility with the three most common imaging
modalities used in breast biopsy, combined with
diverse needle options, the
ATEC(R) system gives radiologists and surgeons the ability to optimize
care
based on individual patient needs. This blood vessel growth is often
associated with malignant
breast tumors.
CAUTIONARY STATEMENT FOR FORWARD-LOOKING STATEMENTS
Statements contained
in this press release may contain information
that includes or is based upon certain "forward-looking
statements"
relating to our business.sclerosing radiologyinfo
Alan Hollingsworth, principal investigator at Mercy Women's
Center,
noted, "Two basic problems keep mammography from being the ultimate answer for
early detection
. First, mammograms miss cancers far more often than is
generally appreciated; secondly, even when
diagnosed by mammography, some
cancers have already spread, such that so-called 'early diagnosis
' is not
early enough., recently gained approval to sell its ATEC(R) Breast Biopsy and
Excision
System in Canada.
"Canadian physicians who have access to breast MRI will be extremely
pleased
with availability of this technology," said Dr. The company has doubled its revenue for
two consecutive
years, reaching $16 million last year, and is on track to
achieve similar results this year.dobimedical
. cannot be assured; the success of our product
development and research efforts; our ability to timely
meet U.ultrasonography mastitis
Unlike most other breast biopsy choices, the ATEC Sapphire(TM) is also
safe to use
with magnetic resonance imaging (MRI), now widely accepted as the
preferred secondary screening tool
for women at high risk for developing
breast disease or cancer. This new system is particularly
important
for high-risk women who will receive annual MRI screenings for many
years to come. Dr.
"The promise
of the ComfortScan system, as demonstrated in this
initial study, warrants additional investigation
, but the preliminary
results are encouraging," stated Dr. Daniel Vanel.radiologyinfo benign
The Company expects enrollment
to continue without any
changes to sites or primary investigators. Since May 2003, more than 5,000
MRI-guided breast
biopsies have been successfully performed using the ATEC(R). Breast cancer patients
account for the
largest number of new cancer patients at the institute (more than 20%
of its patient
base). The ComfortScan system has its CE Mark and UL
for international sales, and DOBI Medical is
a certified ISO 9001:2000
and ISO 13485 company.diti stereotaxic
The Company believes that these specific NAF and
blood serum protein profiles can be used to determine if a woman has a normal
proteomic pattern
or one suggestive of cancer or benign disease. Rash. The Company's identified protein biomarkers, drug
targets, and diagnostic tests are targeted toward markets with critical unmet
needs in areas such
as breast cancer and neurodegenerative disease. The ATEC(R) system has been commercially available
in
the U. The ComfortScan system is a nonionizing,
advanced optical imaging system that uses light-emitting
diodes (LEDs)
and gentle external pressure to identify angiogenesis, the growth of
new blood vessels
, in the breast. In the only case where the ComfortScan system
disagreed with the MRI finding, a three
-month follow-up with MRI
showed up as negative when scanned a second time, aligning the MRI
with
the ComfortScan system findings. Securities and
Exchange Commission, which we strongly urge you to
read and consider,
including our 2004 Annual Report on Form 10-KSB, which may be accessed
from
our website at www.dobimedical.abnormality fibrocystic
The collection of nipple aspirate fluid is a non-invasive procedure
utilizing a modified breast pump to obtain a drop of fluid from the nipple."
"We are pleased
with the continued progress of the breast cancer
validation study and with the number of specific
NAF and blood serum
biomarkers identified to date in this study," said Steven B. Warner.
"Expanding into Canada is an integral part of our broader expansion
strategy and is an important new
market for Suros," said Jim Pearson, Suros
president and CEO.----DOBI Medical
International (DBMI
.D. Investigators also concluded that
ComfortScan system imaging may also be valuable in cases of
claustrophobic patients or in other cases where MRI may be
contraindicated.S.stereotaxic abbi
"Breast MRI
is increasingly being used for diagnostic purposes, including
women with difficult to examine breasts
and with mammograms or ultrasounds
that are difficult to interpret," added Dr."
The ATEC(R
) system is noted for its speed and its ability to address a
broad spectrum of patients, providing
an effective alternative to open
surgical biopsy.
The ComfortScan system is intended to achieve
this by providing new,
physiology-based imagery of abnormal vascularization in the breast not
readily
available today.S.S.
nipple gynecomastia
Any statements in this press release, which are not statements of
historical
fact, may be deemed to be forward-looking statements.
Availability of the ATEC Sapphire(TM) in
Canada will give the estimated
140,000 women who will have a breast biopsy this year an important
new choice
in minimally invasive biopsy methods using ultrasound and stereotactic
mammography
(x-ray) guidance. Current market trends estimate that 200,000 Canadian
women will undergo breast
biopsy annually by 2009. The ATEC Sapphire(TM)
gives these 14,000 high-risk women an option for the
earliest possible
detection of breast disease with a fast, easy and non-surgical diagnostic
breast
biopsy. Suros has various
patents and patents pending in this technology area and is actively working
to
increase its portfolio.
Suros Surgical Systems, Inc. is an Indiana-based medical device
manufacturer of minimally invasive biopsy and tissue excision products.mammography diti
Thus, a great need exists
for a noninvasive screening test that
will not only identify cancers currently being missed by mammography
, but will
also offer earlier detection. In Canada, high risk women account for approximately
5
-10% of patients who undergo breast biopsy annually. This is a huge improvement over what we've been
able to offer women in
the past.
Business Editors/Healthcare Editors
MAHWAH, N.diti dense
Dr. We believe we have engineered the first
test of this type that detects breast cancer more
effectively and earlier than
current technology.Power3Medical. for more than four years and is used
in more than 400 breast
centers and hospitals, including leading institutions like the Cleveland
Clinics, Memorial Sloan Kettering Cancer Center (MRI), Stanford University,
the University of
Pennsylvania, and the Mayo Clinics. The article in EJR reports
that the ComfortScan system could
potentially be a complementary,
adjunctive imaging modality in women with inconclusive mammograms
and/or physical examinations.ultrasonography stereotaxic
Patients' ages ranged between 28 and 78 years of age and all patients
scanned did not have recent trauma, breast surgery or biopsy.com
About DOBI Medical International
, Inc. These forward-looking statements represent
management's current judgment and assumptions, and
can be identified
by the fact that they do not relate strictly to historical or current
facts
. We expressly disclaim any
intent or obligation to update any forward-looking statements.lumps imaginis
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