Wednesday June 30, 10:24 am Eastern Time
Company Press Release
BreastCare Multi Center Results
Presented At the Brazilian
International Mastology Meeting
DENVILLE, N.J.--(BUSINESS WIRE)--June 30, 1999--Scantek
Medical, Inc. (OTCBB: SKML - news) announced today, the results for its Brazilian BreastCare(TM)
clinical study at a special presentation which was held on June 11, 1999 at the International Mastology
Meeting in Sao Paulo, Brazil which was coordinated by Jose Antonio Ribeiro Filho, surgical oncologist
at Academia De Medicina De Brasil and past president of the International Society for Breast Disease
and chaired by Jose Aristodemo Pinotti, Ob/Gyn., Professor at the University Medical Center, Sao
Paulo.
The results of the BreastCare(TM) clinical study were presented by Dr. Alfredo Barros, surgical
oncologist and president of the Brazilian Society of Mastology and Dr. Carlos Menke, gynecologist,
professor of University of Rio Grande Do Sul and Mastologist of the Clinical Center of Porto Alegre.
The physicians who submitted the protocol data were all members of the Brazilian Society of
Mastology. The clinical study was based on a combined protocol to examine the capabilities of
BreastCare with a screening activity and diagnostic validation of selected cases due to suspicion of
cancer. BreastCare results were compared with corresponding mammographic (909 cases) and/or
biopsy (151 cases) results. The data was analyzed and evaluated by Dr. Alvaro Ronco, the head of
Cancer Epidemiology at Pronacam (National Breast Cancer Program, Ministry of Public Health of
Uruguay) and member of the New York Academy of Sciences (New York) and of the Society for
Epidemiological Research (Baltimore).
Assuming the results of mammography performed to patients as the ''gold standard'' or reference
measure, we compared results of BreastCare(TM) against results of mammography. The global
prediction of BreastCare for diagnostic accuracy was 80.2%. Assuming the same, we compared
results of BreastCare(TM) test against the results of biopsy, on that basis, the global prediction of
BreastCare(TM) had diagnostic accuracy of 75.5%.
According to Dr. Ronco, when the interrelationship between clinical breast examination together with
BreastCare(TM) versus mammography was analyzed in the group when positive (+) clinical breast
examination and positive (+) BreastCare(TM), the four (4) cases with negative mammography have as
result, three (3) biopsies (+) for cancer and one (1) negative (--) biopsy. If all results with positive
mammography were assumed as valid ones, diagnostic accuracy combined for clinical breast
examination and BreastCare(TM) would be 98.2%. Following the same line of reasoning, as previous
example, the negative diagnostic accuracy could achieve a maximum of 99.5%.
The diagnostic accuracy of Clinical Breast Examination together with BreastCare(TM) versus biopsy
who tested positive was 97.9% and for those patients who tested negative was 94.1%. A remarkable
fact that there were 11 cases of biopsy confirmed cancers with negative clinical results,
BreastCare(TM) was positive (+) 8 times. In the 3 cancers lost, 2 were in situ and only one an invasive
cancer.
Dr. Ronco summarized the new results as follows: 1) If clinical breast examination is normal or
doubtful (absence of suspicion of cancer) and the BreastCare(TM) test is (--), the probability of
absence of cancer confirmed by biopsy is around 95%. 2) If clinical breast examination is suspicious of
cancer and BreastCare test is (+), the probability of having cancer is 98-100%. 3) The performance of
the device is slightly better in women under 50 years old, who are mainly pre menopausal.
Mr. Sagi, the company's president and chief executive officer, said, ''The company is very pleased
with the results. We believe that BreastCare(TM) can be a valuable tool in the hands of the physicians.
The results of this study will be submitted for publication jointly with another study which is on going.''
Mr. Sagi also stated, ''The Company has received very positive response from physicians and
government agencies and it is anticipated will be reflected in the first quarter beginning July 1, 1999 and
ending September 30, 1999.''
The BreastCare(TM) device or BreastAlert(TM) Differential Temperature Sensor is a non-invasive,
easy to use, low cost, adjunctive test used by physicians. The device is cleared for marketing by the
FDA in the United States and is designed to complement, not replace, conventional breast disease
screening methods, (i.e., clinical breast examination, mammography, and other established clinical
procedures.) Currently the device is being used in South America and at this time on a limited basis in
the United States. The company anticipates the relaunch of the BreastCare(TM)/BreastAlert(TM) in
the United States in about 10 to 12 months, subject to the completion of certain financing.
Scantek Medical, Inc. is a high-tech medical company engaged in developing, manufacturing, selling
and licensing of products and devices to assist in the diagnosis and early detection of disease. At the
present time, the Company is focused on manufacturing, selling and licensing the BreastCare(TM)
device globally. The BreastCare(TM)/BreastAlert(TM) device is to be used by physicians as an
adjunct to clinical breast examination, mammography and other established procedures for the
detection of breast disease.
Certain statements in this press release with respect to future expectations and plans may be regarded
as ''forward-looking statements'' with the meaning of Section 27A of the Securities Act of 1933,
Section 21E of the Securities Exchange Act of 1934, and as that term is defined in the Private
Securities Litigation Reform Act of 1995. Such statements involve risks and uncertainties and are
subject to change at any time. The Company's actual results could differ materially from such
statements.
Contact:
Scantek Medical, Inc.
Mr. Zsigmond L. Sagi, 973/366-5250
by
Financial Communication Associates
Mr. David Evanson, 610/649-3604
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