Todos Medical Achieves Medical Importer Status with US FDA
April 15, 2020 08:38 ET | Source: Todos Medical Ltd.
REHOVOT, Israel, SINGAPORE and NEW YORK, NY, April 15, 2020 (GLOBE NEWSWIRE) -- via NEWMEDIAWIRE -- Todos Medical Ltd. (OTCQB: TOMDF), a commercial in vitro diagnostics company focused on the development of blood tests for the early detection of cancer and neurodegenerative disorders, today announced that the United States Food & Drug Administration has accepted Todos Medical’s application for Medical Device Establishment Registration. This designation allows Todos to import medical devices for commercial sale that have been manufactured by non-US entities. Todos has entered into agreements to import point-of-care (POC) antibody fingerprick blood-based testing kits (Ab POC Testing Kits) and COVID-19 digital PCR-based testing kits from oral/nasopharyngeal swabs, saliva and stool (PCR Testing Kits), as well as automated extraction laboratory equipment (Automated Extraction) to support a newly established risk stratification screening and reflex high throughput diagnostic testing paradigm that it believes will allow for greater access to highly accurate testing in the United States. Todos intends to distribute Ab PCR Testing Kits to medical providers, pharmacies and government entities throughout the United States, and market PCR Testing Kits and Automated Extraction to CLIA/CAP-certified labs in the United States in addition to running PCR Testing Kits using Automated Extraction in its partner CLIA/CAP-certified lab.
About the SARS-CoV-2 Coronavirus (COVID-19)
Coronaviruses are a family of viruses that can lead to respiratory illness, including Middle East Respiratory Syndrome (MERS-CoV) and Severe Acute Respiratory Syndrome (SARS-CoV). Coronaviruses can be transmitted between animals and people and evolve into strains not previously identified in humans. On January 7, 2020, a novel coronavirus (SARS-CoV-2) was identified as the cause of pneumonia cases in Wuhan, Hubei Province of China, and additional cases have been found in a growing number of countries worldwide. COVID-19 is the disease caused by SARS-CoV-2.
About Todos Medical Ltd.
Headquartered in Rehovot, Israel, Todos Medical Ltd. (OTCQB: TOMDF) engineers life-saving diagnostic solutions for the early detection of a variety of cancers. The Company's state-of-the-art and patented Todos Biochemical Infrared Analyses (TBIA) is a proprietary cancer-screening technology using peripheral blood analysis that deploys deep examination into cancer's influence on the immune system, looking for biochemical changes in blood mononuclear cells and plasma. Todos' two internally-developed cancer-screening tests, TMB-1 and TMB-2, have received a CE mark in Europe and are currently in a pre-commercial study with its distribution partner Orot+ (a division of Luces-Orot). Todos recently entered into an exclusive option agreement to acquire U.S.-based medical diagnostics company Provista Diagnostics, Inc. to gain rights to its Alpharetta, Georgia-based CLIA/CAP certified lab and Provista's proprietary commercial-stage Videssa® breast cancer blood test. The transaction is expected to close in the second quarter of 2020.
Through Breakthrough Diagnostics, Inc., its joint venture with Amarantus Bioscience Holdings, Inc. (OTC: AMBS), Todos is also actively involved with the development of blood tests for the early detection of neurodegenerative disorders, such as Alzheimer's disease. Todos expected to complete the remaining unowned interest in Breakthrough in the second quarter of 2020.
Todos recently entered into distribution agreements with China-based companies to distribute certain novel coronavirus (COVID-19) test kits. The Company has entered into distribution agreements covering the U.S. and Israel with Gibraltar Brothers & Associates, LLC, a U.S.-based subsidiary of Shanghai Liangrun Biomedicine Technology Co. (Shanghai), for its proprietary colloidal gold immunochromatography (Colloidal Gold) point-of-care IgM/IgM-based antibody test kits, and with 3DMedicine Science & Technology Co (3DMed), a China-based cancer precision medicine company, for distribution in the U.S. and Israel of its ANDiS® SARS-CoV-2 Detection Kit (COVID), ANDiS® SARS-CoV-2 & Influenza A/B Detection Kit (COVID/Flu) and its proprietary ANDiS®350 3DMed Automated Solution countertop real-time PCR machine (3D Machine). Todos has formed Corona Diagnostics, LLC, a joint venture with Emerald Organic Products, Inc. (OTC: EMOR), to support the commercialization of its COVID-19 testing paradigm.
For more information, please visit https://www.todosmedical.com/
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.
Investor and Corporate Contact:
Kim Sutton Golodetz
LHA Investor Relations
Senior Vice President
(212) 838-3777
kgolodetz@lhai.com
Corporate Contact:
Daniel Hirsch
Todos Medical
(347) 699-0029
Dan.h@todosmedical.com
http://www.globenewswire.com/news-release/202...S-FDA.html
April 15, 2020 08:38 ET | Source: Todos Medical Ltd.
REHOVOT, Israel, SINGAPORE and NEW YORK, NY, April 15, 2020 (GLOBE NEWSWIRE) -- via NEWMEDIAWIRE -- Todos Medical Ltd. (OTCQB: TOMDF), a commercial in vitro diagnostics company focused on the development of blood tests for the early detection of cancer and neurodegenerative disorders, today announced that the United States Food & Drug Administration has accepted Todos Medical’s application for Medical Device Establishment Registration. This designation allows Todos to import medical devices for commercial sale that have been manufactured by non-US entities. Todos has entered into agreements to import point-of-care (POC) antibody fingerprick blood-based testing kits (Ab POC Testing Kits) and COVID-19 digital PCR-based testing kits from oral/nasopharyngeal swabs, saliva and stool (PCR Testing Kits), as well as automated extraction laboratory equipment (Automated Extraction) to support a newly established risk stratification screening and reflex high throughput diagnostic testing paradigm that it believes will allow for greater access to highly accurate testing in the United States. Todos intends to distribute Ab PCR Testing Kits to medical providers, pharmacies and government entities throughout the United States, and market PCR Testing Kits and Automated Extraction to CLIA/CAP-certified labs in the United States in addition to running PCR Testing Kits using Automated Extraction in its partner CLIA/CAP-certified lab.
About the SARS-CoV-2 Coronavirus (COVID-19)
Coronaviruses are a family of viruses that can lead to respiratory illness, including Middle East Respiratory Syndrome (MERS-CoV) and Severe Acute Respiratory Syndrome (SARS-CoV). Coronaviruses can be transmitted between animals and people and evolve into strains not previously identified in humans. On January 7, 2020, a novel coronavirus (SARS-CoV-2) was identified as the cause of pneumonia cases in Wuhan, Hubei Province of China, and additional cases have been found in a growing number of countries worldwide. COVID-19 is the disease caused by SARS-CoV-2.
About Todos Medical Ltd.
Headquartered in Rehovot, Israel, Todos Medical Ltd. (OTCQB: TOMDF) engineers life-saving diagnostic solutions for the early detection of a variety of cancers. The Company's state-of-the-art and patented Todos Biochemical Infrared Analyses (TBIA) is a proprietary cancer-screening technology using peripheral blood analysis that deploys deep examination into cancer's influence on the immune system, looking for biochemical changes in blood mononuclear cells and plasma. Todos' two internally-developed cancer-screening tests, TMB-1 and TMB-2, have received a CE mark in Europe and are currently in a pre-commercial study with its distribution partner Orot+ (a division of Luces-Orot). Todos recently entered into an exclusive option agreement to acquire U.S.-based medical diagnostics company Provista Diagnostics, Inc. to gain rights to its Alpharetta, Georgia-based CLIA/CAP certified lab and Provista's proprietary commercial-stage Videssa® breast cancer blood test. The transaction is expected to close in the second quarter of 2020.
Through Breakthrough Diagnostics, Inc., its joint venture with Amarantus Bioscience Holdings, Inc. (OTC: AMBS), Todos is also actively involved with the development of blood tests for the early detection of neurodegenerative disorders, such as Alzheimer's disease. Todos expected to complete the remaining unowned interest in Breakthrough in the second quarter of 2020.
Todos recently entered into distribution agreements with China-based companies to distribute certain novel coronavirus (COVID-19) test kits. The Company has entered into distribution agreements covering the U.S. and Israel with Gibraltar Brothers & Associates, LLC, a U.S.-based subsidiary of Shanghai Liangrun Biomedicine Technology Co. (Shanghai), for its proprietary colloidal gold immunochromatography (Colloidal Gold) point-of-care IgM/IgM-based antibody test kits, and with 3DMedicine Science & Technology Co (3DMed), a China-based cancer precision medicine company, for distribution in the U.S. and Israel of its ANDiS® SARS-CoV-2 Detection Kit (COVID), ANDiS® SARS-CoV-2 & Influenza A/B Detection Kit (COVID/Flu) and its proprietary ANDiS®350 3DMed Automated Solution countertop real-time PCR machine (3D Machine). Todos has formed Corona Diagnostics, LLC, a joint venture with Emerald Organic Products, Inc. (OTC: EMOR), to support the commercialization of its COVID-19 testing paradigm.
For more information, please visit https://www.todosmedical.com/
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.
Investor and Corporate Contact:
Kim Sutton Golodetz
LHA Investor Relations
Senior Vice President
(212) 838-3777
kgolodetz@lhai.com
Corporate Contact:
Daniel Hirsch
Todos Medical
(347) 699-0029
Dan.h@todosmedical.com
http://www.globenewswire.com/news-release/202...S-FDA.html
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