CTI Receives Medical Device License to Market Breast Cancer Thermal Imaging System (BCS2100) in Canada.
April 27 2004 - 9:00AM
PR Newswire (US)
CTI Receives Medical Device License to Market Breast Cancer Thermal
Imaging System (BCS2100) in Canada. OGDEN, Utah, April 27
/PRNewswire-FirstCall/ -- Computerized Thermal Imaging Inc. (CTI)
(BULLETIN BOARD: COIB) announced that it has received a Medical
Device License from Health Canada to market its Breast Cancer
Imaging System (BCS2100) in Canada. The BCS2100 uses infrared
thermal imaging (IR) as an adjunct device to assist doctors in the
early detection and discrimination of breast cancer. The process is
designed to be quick, painless, non-invasive, and requires no
patient exposure to radiation, breast compression, or electrical
current. Dr. J.R. Keyserlingk, Medical Directors of VilleMarie
Breast and Oncology Center in Montreal stated that, "Integrating IR
imaging into the first-line strategy for the detection of breast
cancer can increase the sensitivity at this crucial stage by
providing an early warning of an abnormality that in some cases is
not evident in other components. Combining IR imaging and
mammography in an IR-assisted mammography strategy is particularly
appealing in the current era of increased emphasis on screening by
imaging and less reliance on palpation as tumor size further
decreases." "I am pleased that CTI has received a Medical Device
License to market the BCS 2100 in Canada," said Richard Secord, CTI
Chairman and CEO. "CTI is in business to improve the quality of
life through the development and deployment of thermal imaging and
associated technologies. Our goal is to provide radiologists
additional information to assist them in better determining the
need for surgical biopsy." As part of the Medical Device License,
CTI was required to be certified to the international quality
system requirements for medical devices, ISO 13485, and be audited
by a recognized registrar for compliance with the Canadian Medical
Devices Conformity Assessment System (CMDCAS) which was completed
in October of 2003. CTI's Thermal Image Processor (TIP) is the core
imaging device within the BCS 2100. CTI has placed or sold over 120
TIP systems worldwide. The TIP system is designed for use in
thermal screening for cancer as well as other physiological
ailments. Three of theses TIP systems are being used by the
Canadian Government in airports measuring elevated skin
temperatures in connection with SARS screening. The TIP System and
the Photonic Stimulator, another product of CTI, have also received
a Medical Device License from Health Canada, as well as 510(k)
clearance by FDA in the USA. CTI believes its three Canadian
distributors are looking forward to adding the BCS 2100 to the
leasing program recently provided by the $500 million commitment
from Associated International Leasing Corp. CTI believes the new
leasing program will allow doctors and other practitioners to lease
the BCS 2100 on a monthly payment program, which may be more
affordable than an outright purchase. At this time the BCS 2100 is
not available for sale in the USA. CTI continues to seek FDA
pre-market approval to market and sell the BCS2100 as an adjunct to
mammography and clinical examination in the detection of breast
cancer. About CTI CTI designs, manufactures and markets thermal
imaging and infrared devices and services used for clinical
diagnosis, pain management and non-destructive testing of
industrial products and materials. CTI has developed six
significant proprietary technologies, four of which relate to its
breast imaging system, BCS 2100. These include a climate-controlled
examination unit to provide patient comfort and facilitate
reproducible tests for the BCS 2100; an imaging protocol designed
to produce consistent results for the BCS 2100; a statistical model
that detects physiological irregularities for the BCS 2100, and
infrared imaging and analysis hardware, including a proprietary
heat-sensing camera. CTI also markets the Thermal Image Processor
and Photonic Stimulator, two cleared pain management devices used
for diagnostic imaging and therapeutic treatment. THIS PRESS
RELEASE CONTAINS "FORWARD-LOOKING STATEMENTS" WITHIN THE MEANING OF
SECTION 27A OF THE SECURITIES ACT OF 1933, AS AMENDED, AND SECTION
21E OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. THESE
FORWARD-LOOKING STATEMENTS ARE SUBJECT TO CERTAIN RISKS, TRENDS AND
UNCERTAINTIES THAT COULD CAUSE ACTUAL RESULTS TO DIFFER MATERIALLY
FROM THOSE PROJECTED. AMONG THOSE RISKS, TRENDS AND UNCERTAINTIES
ARE CTI'S PENDING APPLICATION BEFORE THE FDA SEEKING PRE-MARKET
APPROVAL OF CTI'S BCS 2100 BREAST IMAGING SYSTEM, CTI'S ABILITY TO
RAISE ADDITIONAL CAPITAL TO FUND CASH REQUIREMENTS FOR FUTURE
OPERATIONS AND CTI'S ABILITY TO CONTINUE AS A GOING CONCERN. IN
PARTICULAR, CAREFUL CONSIDERATION SHOULD BE GIVEN TO CAUTIONARY
STATEMENTS MADE IN THE VARIOUS REPORTS CTI HAS FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION. CTI UNDERTAKES NO DUTY TO
UPDATE OR REVISE THESE FORWARD-LOOKING STATEMENTS. DATASOURCE:
Computerized Thermal Imaging Inc. CONTACT: BJ Mendenhall of
Computerized Thermal Imaging Inc., +1-801-776-4700, ext. 31 Web
site: http://www.cti-net.com/
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