Todos Medical Receives Approval from Israeli Ministry of Health (AMAR) to Market and Sell its Breast Cancer Screens in Israel
REHOVOT, Israel, May 23, 2019 (GLOBE NEWSWIRE) -- Todos Medical Ltd. (OTCQB: TOMDF), a clinical-stage in-vitro-diagnostics company focused on the development of blood tests for the early detection of cancer and neurodegenerative disorders, such as Alzheimer's disease, today announced that it has received approval from the Israeli Ministry of Health (AMAR) to market and sell its breast cancer tests TM-B1 and TM-B2.
“We are happy to achieve this important milestone approval from the Ministry of Health of the State of Israel. This approval, along with our recent signing of a distribution agreement for our cancer screens with Care GB in Israel, enables us to move forward at full strength to commercialize our products,” said Dr. Herman Weiss, CEO of Todos Medical. “We are now actively working to begin sales in Austria, Romania and Israel.”
Todos Medical has developed cancer screens utilizing its proprietary Total Biochemical Infrared Analysis (TBIA) technology. Todos’s TM-B1 breast cancer screen to detect the presence of malignancy. The Company’s TM-B2 breast cancer screen is designed for women diagnosed with BI-RADS 3 or 4 to distinguish between benign and malignant tumors. Additionally, we are in the process of developing a colon cancer screen.
About Todos Medical Ltd.
Todos Medical Ltd. (OTCQB: TOMDF), an Israeli company headquartered in Rehovot, is an in-vitro-diagnostic (“IVD”) company engaged in the development of a series of blood tests for the early detection of a variety of cancers and has initiated the development of blood tests for neurodegenerative disorders, such as Alzheimer's disease, through Breakthrough Diagnostics, Inc., its joint venture with Amarantus Bioscience Holdings, Inc. (OTCPK:AMBS). The company has developed two cancer screening tests based on TBIA (Todos Biochemical Infrared Analyses), a method for cancer screening using peripheral blood analysis. The TBIA screening method is based on the cancer’s influence on the immune system which triggers biochemical changes in peripheral blood mononuclear cells (“PBMC”) and plasma. This proprietary and patented method incorporates biochemistry, physics and signal processing. The company’s two cancer screening tests, TM-B1 and TM-B2 are CE marked in the EU. Breakthrough Diagnostics is developing the Alzheimer’s blood diagnostic LymPro Test®.
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Forward-looking statements: Certain statements contained in this press release may constitute forward-looking statements. For example, forward-looking statements are used when discussing our expected clinical development programs and clinical trials. These forward-looking statements are based only on current expectations of management, and are subject to significant risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements, including the risks and uncertainties related to the progress, timing, cost, and results of clinical trials and product development programs; difficulties or delays in obtaining regulatory approval or patent protection for product candidates; competition from other biotechnology companies; and our ability to obtain additional funding required to conduct our research, development and commercialization activities. In addition, the following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; delays or obstacles in launching our clinical trials; changes in legislation; inability to timely develop and introduce new technologies, products and applications; lack of validation of our technology as we progress further and lack of acceptance of our methods by the scientific community; inability to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties that may develop with our process; greater cost of final product than anticipated; loss of market share and pressure on pricing resulting from competition; and laboratory results that do not translate to equally good results in real settings, all of which could cause the actual results or performance to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Todos Medical does not undertake any obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Todos Medical, please refer to its reports filed from time to time with the U.S. Securities and Exchange Commission.
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Released May 23, 2019