Todos Medical Ltd. (OTC: TOMDF) Is a Biotech Stock Positioning Itself as a Company responding to the current COVID-19 crisis and Aims to Become a Pioneer in Early Cancer and Alzheimer’s Disease Detection


Sponsored Content By: Todos Medical Ltd.
10:15 1/12/2021


Innovations adopted during the coronavirus crisis not only drive revenue but generate new opportunities.

Testing for the virus has become increasingly important. Recent advances in vaccine development are driving immune testing to understand whether immunity has been attained in individuals, either by prior COVID-19 infection or COVID-19 vaccination.

Todos Medical Announces $4.8 Million in Sales for December 2020, a 50% Month Over Month Increase in Sales from November 2020
(Released Jan. 11, 2021)

Todos Medical LTD ( TOMDF ) is executing on the COVID revenue opportunity with distribution agreements to distribute certain novel coronavirus test kits and has established relationships with leading companies that are developing next-generation immune-based blood testing.

COVID-19 is a worldwide crisis, cancer cases are on the rise, and Alzheimer’s disease currently has no blood test for early detection.

The COVID-19 pandemic is in its worst and deadliest phase and the U.S. is bracing for very harsh winter months.

Cases of the virus this past fall have proven to be the most intense period for new infections of the entire pandemic.

The United States has ended up in a health emergency and economic fall out because of the virus.

Moderna and Pfizer have received emergency FDA clearance for their coronavirus vaccines, but we still have a long way to go to solve this crisis.


www.todosmedical.com

Headquartered in Rehovot, Israel, Todos Medical LTD ( TOMDF ) is focused on distributing comprehensive solutions for COVID-19 screening and diagnosis and developing blood tests for early detection of cancer and Alzheimer’s disease.

COVID-19 Testing

Todos Medical LTD ( TOMDF ) has entered into distribution agreements with companies to distribute certain novel coronavirus (COVID-19) test kits.

The agreements cover multiple international suppliers of PCR testing kits and related materials and supplies, as well as antibody testing kits from multiple manufacturers after completing validation of said testing kits and supplies in its partner CLIA/CAP certified laboratory in the United States.

The company has formed strategic partnerships with Integrated Health LLC, MOTOPARA Foundation to deploy mobile COVID-19 testing in the United States and it has also established relationships with leading companies that are developing next-generation immune-based blood testing.

Todos Medical LTD ( TOMDF ) has positioned itself as a ‘one stop shop’ for all things COVID testing related and offers different types of testing products they make available to clients.

Polymerase Chain Reaction (PCR) Testing

PCR testing is now the gold-standard in COVID-19 testing. Definitive diagnoses are almost exclusively confirmed by PCR. As such, screening and surveillance testing of any kind will ultimately lead to a confirmatory PCR test.

Todos Medical Announces Agreement to Supply Natural Wellness Clinics with COVID-19 Testing Products to Support Initiatives in the Commonwealth of Kentucky
(Released Dec. 23, 2020)

Equipment to create workflows capable of conducting over 20,000 PCR tests per day per lab include:

  1. RNA automated extraction machines
  2. RT-PCR machines (96 well and 384 well)
  3. Liquid handler machines
  4. Automated and semi-automated pipettes

Reagents and consumables include:

  1. Extraction reagent kits
  2. COVID and COVID + influenza a/b qPCR reagent kits
  3. Swab and Viral Transport Medium kits
  4. Robotic and manual pipette tips
  5. PCR plates
  6. Validation Samples

Todos Medical LTD ( TOMDF ) has optimized a workflow with Tecan liquid handlers currently being implemented at its Wisconsin client that will allow its lab to reach at least 20,000 diagnostic tests per day; and with pooling strategies being deployed for screening purposes, this client is expected to reach capacity to conduct over 100,000 tests per day.

The Market Opportunity...

Todos Medical LTD ( TOMDF ) expects that as the capacity for PCR testing in the United States continues to increase nationally, the market opportunity for its kits will continue to grow as labs realize that without a COVID-19 testing business they may lose testing business from clients in other areas because of the increasing need for testing in skilled nursing facilities and physician’s offices.

As we continue to hear about testing at schools nationwide becoming more prevalent, the company believes the trend of increased testing needs will only continue to increase in the near and medium term as stakeholders look to mitigate risk while getting back to normal life.


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Rapid Antigen Testing

Antigen testing allows for testing at lower accuracy rates than PCR, but with much faster turnaround times because the results are provided at the point of care. As such, it screens more people faster and take immediate action if a positive test leads to a suspected case of COVID-19 that needs to be confirmed by PCR.

Todos Medical LTD ( TOMDF ) has entered into several agreements with companies focused on bringing antigen tests into the marketplace.

While sales have been focused on PCR testing, the company believes rapid antigen testing will become routine in the United States in the months ahead as new tests enter the marketplace and bring prices down to a level where tests can be deployed in virtually any setting.

The company has entered into one agreement in particular with a US-based manufacturer that expects to receive FDA Emergency Use Authorization (EUA) for its test in the near future, and has significant plans to allow the company’s sub-distribution network to aggressively market this test upon approval.

Rapid Antibody Testing

As schools, employers and other constituents begin to implement comprehensive COVID-19 surveillance programs, one of the key questions emerging is whether individuals have previously been infected with COVID-19.

Todos Medical LTD ( TOMDF ) has secured rights to the FaStep rapid SARS-CoV-2 antibody test and have added this to its offering to sub-distribution partners.

Emerging COVID-19 Testing Technologies

Todos Medical LTD ( TOMDF ) has also secured rights to several tests that are currently awaiting EUA approval from the FDA. These tests include point-of-care PCR tests that is expected to compete with the Abbott ID Now™ and Cepheid point of care molecular tests.

The company expects to enter into an agreement to secure distribution rights to lab-based tests to more comprehensively evaluate COVID-19 immune-status that it believes will become paramount as vaccines enter the marketplace and testing for immunity becomes more widespread in 2021.

Additionally, the company is continuing to make significant progress with its 3CL protease rapid saliva/buccal test, being developed via its joint venture, COVID Antigen Test Killer LLC.

The company believes the 3CL tests it is developing will ultimately replace antigen testing because it adds important ‘active virus’ information to currently available PCR and antigen tests for COVID positive patients.

Todos Medical LTD ( TOMDF ) intends to first bring to market a lab-based test that will monitor PCR positive COVID-19 infected patients for active viral load, and thereafter a point of care test that can be used to replace antigen testing for screening and surveillance purposes. Data is expected to be released from the company’s ongoing studies in Israel shortly.

Mobile Labs

One of the most innovative programs Todos Medical LTD ( TOMDF ) has been working on is the biosafety level 3 (BSL3) mobile labs solution that has been making steady progress and has now completed all of the instrument and clinical sample validation required to be able to receive CLIA certification for PCR testing.

The mobile labs have the ability to conduct over 2,000 PCR tests per day, have been equipped with rapid antigen testing machines as well as lateral flow point of care antigen tests that will allow its implementation partners to conduct testing on large groups and confirm suspected COVID-19 cases by PCR, as well as do large scale PCR testing onsite with turnaround times of as little as 6 hours.

The company currently has 2 mobile labs in the final stages of authorization and have secured 10 additional mobile lab units that it will begin to build-out upon certification of the first unit.

The company believes this initiative is innovative and timely because it addresses many of the key logistical challenges surrounding COVID-19 testing and opens the possibility of also being used as the basis for added healthcare services around testing that will become increasingly important in 2021.

Tollovid™ – Immune Boosting Dietary Supplement

Dr. Anthony Fauci, the Director of the National Institute of Allergy and Infectious Diseases, disclosed in early 2020 to various news outlets that he was taking dietary supplements Vitamin C and Vitamin D in an effort to boost his immune system to defend against COVID-19.

Todos Medical Ltd.’s joint venture with NLC Pharma has gained exclusive rights to bring to market the dietary supplement Tollovid, a 3CL protease inhibiting formulation of plant extracts designed to support and maintain healthy immune function.

The company has licensed the exclusive worldwide distribution rights for Tollovid, excluding Israel, from Israel-based joint venture partner NLC Pharma in September 2020.

NLC Pharma Ltd., an Israeli company, was founded by Dr. Dorit Arad, a leading physical organic chemist with more than 25 years of experience in the Life Science industry, specifically in research and development of infectious diseases.

The 3CL protease plays a vital role in the intracellular replication of coronaviruses.

The company also believes Tollovid has a first-mover advantage in the 3CL protease inhibition space because it has received a Certificate of Free Sale by the FDA based largely on the data that has been generated by NLC in understanding how 3CL protease inhibition impacts the replication of coronaviruses generally.

The proprietary Tollovid formulation has been optimized to maximize 3CL protease inhibition using natural products, and Todos Medical LTD ( TOMDF ). believes the current capsule formulation will become the basis of a line of products based on Tollovid’s active, 3CL protease-inhibiting ingredients.

NLC recently completed certain experiments with Tollovid against actively circulating coronaviruses, and NLC expects to make that data available to the public in Israel in the weeks ahead. Todos Medical LTD ( TOMDF ) is now focused on the commercial launch of Tollovid at The Alchemist’s Kitchen™ where the company believes it can gain immediate traction with wellness-minded consumers looking for plant-based solutions to support and maintain immune function at this time of heightened viral infection risk.

The Alchemist's Kitchen is a plant-based wellness brand dedicated to the education of consumers to the potential benefits of botanical medicines and herbal remedies. It develops and markets proprietary formulations via retail and online channels of distribution. The flagship storefront is located at 119 Crosby St, New York, NY 10003. Its website is www.thealchemistskitchen.com. Todos Medical LTD ( TOMDF ) is also creating its own Todos brand for the Tollovid product and will make that available after it has received sufficient market information from the initial product launch at The Alchemist’s Kitchen.

Todos Medical LTD ( TOMDF ) has secured the rights to distribute AditxtScore™ for COVID-19 to monitor immunity against SARS-CoV-2.

The company has signed a distribution agreement with Aditx Therapeutics, Inc. for AditxtScore™ for COVID-19, with planned availability in January 2021.

Blood samples will be collected by Todos and/or its network of partners and sent to Aditxt’s CLIA accredited AditxtScore™ Center for processing.

The AditxtScore™ for COVID-19 scoring system will initially include antibody and neutralizing antibodies, and will soon include T-cell and B-cell responses as well.

Todos Medical LTD ( TOMDF ) is Aditxt’s first commercial customer for the proprietary AditxtScore™ immune monitoring platform and its first application, AditxtScore™ for COVID-19.

Cancer Detection

The Company's state-of-the-art and proprietary Todos Biochemical Infrared Analyses (TBIA) is a 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.

The company has two internally-developed cancer-screening tests, TMB-1 and TMB-2, which have received a CE mark in Europe. The company also 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.

Limits of Current Cancer Screening

Screening tests for cancer in general, and breast, colon, lung cancers specifically, have well known limitations and compliance shortcomings due to their scientific limitations, invasive procedures, and expensive nature of more accurate diagnostic methods.

More importantly, many of the most effective diagnostic methods remain too expensive for adoption as screening tests for all those at risk. They are also used too rarely and at too late a stage to allow for the most effective treatment.

The Solution

Blood based tests are the future of cancer screening. The company’s TBIA platform, represents a cost effective, scalable, and patient friendly screening method for cancer screening. Todos Medical LTD ( TOMDF ) new cancer test will add a layer to currently available cancer screening and diagnostics. The new method is easy to implement and at a low cost, currently targeting the mass population as the first choice for cancer detection.

The technology is a platform, and the company is investigating methods for using its platform on other types of cancers. Initially the company is focused on breast and colon cancers.

The TBIA Platform – Advanced Cancer Screening

Todos Medical LTD ( TOMDF ) has developed the "Total Biochemical Infrared Analysis" (TBIA) method, a proprietary method for screening of solid tumors using peripheral blood spectroscopy analysis.

The process involves observing the immune system’s response to tumor presence rather than looking for the tumor cells themselves or specific markers.

TBIA analyzes the entire biochemical signatures spectrum (including proteins, lipids, nucleic acids and carbohydrates) of effected immune cells from peripheral blood, using infrared spectroscopy.

  • Advances in mid infrared spectroscopy (FTIR) open new diagnostic frontiers
  • Immune system changes detected in plasma and mononuclear cells via FTIR
  • Immune response acts as body’s sensor for cancer
  • FTIR allows observation of distinct immune response to breast, colorectal, lung and other cancer types

Alzheimer’s Disease Detection

Todos Medical LTD ( TOMDF ) is developing blood tests for the early detection of neurodegenerative disorders, such as Alzheimer's disease.

Currently there are no blood tests that can diagnose Alzheimer's before symptoms develop which complicates studies of early treatments or preventive strategies.

The Lymphocyte Proliferation Test (LymPro Test™) is a diagnostic blood test that determines the ability of peripheral blood lymphocytes (PBLs) and monocytes to withstand an exogenous mitogenic stimulation that induces them to enter the cell cycle.

It is believed that certain diseases, most notably Alzheimer's disease, are the result of compromised cellular machinery that leads to aberrant cell cycle re-entry by neurons, which then leads to apoptosis.


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LymPro is novel in the use of peripheral blood lymphocytes as a surrogate for neuronal cell function, suggesting a common relationship between PBLs and neurons in the brain.

Someone in the United States develops Alzheimer’s every 65 seconds. It is the most common form of dementia, a progressive brain disease that slowly destroys memories and thinking skills. It often starts 5, 10, or even 20 years before symptoms appear.

WHO IS TODOS MEDICAL LTD

Gerald Commissiong - Chief Executive Officer and Director

Mr. Commissiong is currently a director and President & CEO of Amarantus Bioscience Holdings, Inc. and is interim-CEO of Breakthrough Diagnostics, Inc., Todos’ joint venture with Amarantus. Mr. Commissiong has been responsible for Amarantus’ strategic transactions, licensing, research collaborations, mergers & acquisitions in therapeutics and diagnostics, as well as fund raising, having raised over of $50 million since inception. Prior to co-founding Amarantus, Mr. Commissiong played professional football for the Calgary Stampeders of the Canadian Football League. Mr. Commissiong received a B.Sc. in Management Science and Engineering with a focus on Financial Decisions from Stanford University.

Dr. Jorge Leon, Ph.D. - Consulting Chief Medical and Scientific Officer of Infectious Disease and Oncology

Dr. Leon is internationally recognized for his pioneering work in molecular diagnostics. He holds a Ph.D. in cellular and molecular biology from New York University, and completed his postdoctoral studies at the German Cancer Research Center in Heidelberg and Columbia University in New York. Dr. Leon’s subsequent academic research at Columbia University focused on developing monoclonal antibody-based tumor marker assays and radio-immuno imaging devices, which are currently in wide use.

In the early 1990s, Dr. Leon played an integral role in establishing and leading the molecular diagnostics laboratories at Quest Diagnostics. As Director of Molecular Diagnostics, Senior Director of Biotechnology Development and Vice President of Applied Genomics, Dr. Leon spent 12 years developing Quest’s molecular diagnostics strategy, which is now the world’s largest molecular diagnostics service laboratory. In 2003, Dr. Leon founded Leomics Associates, Inc., a consulting firm committed to helping prestigious, successful companies and academic institutions develop molecular diagnostics and personalized medicine in the United States and globally. Dr. Leon specializes in identifying breakthrough opportunities and industry trends, and helps start-up businesses, academic centers and established companies successfully build and commercialize innovative business strategies, product pipelines and test menus.

Rami Zigdon, MBA - Chief Business Officer, Co-founder

Mr. Zigdon brings with him strong experience leading technology companies. Prior to founding Todos Medical with Dr. Udi Zelig and Mr. Shmuel Melman, he served as the country manager for Hitachi Semiconductors and Renesas Technology. He also served as a manager at Scitex Corporation (presently a division of Kodak), and as the Chief Technology Officer of NI Medical. Mr. Zigdon has been recognized for his leadership in the development and implementation of effective product development strategies and FDA submissions.

Mr. Zigdon has served as CEO since our inception in 2010 and was appointed as a director of our Company in May 2016. From May 2011 through June 2015, he also served as a director. From 2003 to 2009, Mr. Zigdon served as sales manager for Israel of Renesas Technology, a leading Japanese semiconductors corporation. Prior to this position, Mr. Zigdon served as the manager of Hitachi Semiconductors Israel and as embedded systems group manager at RDT. Mr. Zigdon has held various technical and management positions at Scitex (in Belgium), NI Medical and Spectronix.

Mr. Zigdon holds a BS in Biology from the Hebrew University in Jerusalem where he graduated with honors, a BS in Electrical Engineering from Ben Gurion University of the Negev, Beersheba, and a MBA from the Heriot-Watt University, Edinburgh.

Daniel Hirsch, MPH - Chief Financial Officer and Director

Mr. Hirsch as over 25 years of experience with a demonstrated history of working with public companies. Mr. Hirsch has management and business development expertise to go along with a strong background in investor relations.

Dr. Elise Brownell - Vice President of Research & Development

Dr. Elise Brownell Serves as the VP of Research & Development at Todos Medical. Her main responsibilities center around advancing the Company’s portfolio through regulatory approval. She has spent the last 35 years in the bio/pharmaceutical arena where she has played key roles in discovery, development and opportunity assessment to drive innovation. After completing her doctorate at Yale University, Elise’s career started at SUNY Stony Brook. She continued her interest in comparative molecular biology during her tenure at Frederick Cancer Research Facility and expanded her facility with molecular genetics while in various functions at Bayer Healthcare. Her efforts were widely recognized by promotion to Director, Project Management, where she led global cross-functional teams. Elise also became a member of the founding team of a venture-backed spin out (Aerovance, Inc), where she became head of project management. Dr. Brownell serves in Interim Executive capacities for a number of emergent and highly innovative companies in the Life Science sector and is the EVP of Operations and Project Management at Amarantus Bioscience Holdings, Inc. Elise received her MS, MPhil and PhD from Yale University, and her BS from Allegheny College.

Priyanka Misra - Vice President of Corporate Development

Ms. Priyanka Misra serves as the VP of Corporate Development at Todos Medical. Her main responsibilities include designing and implementing best practices for immediate sales progression, facilitating strategic partnerships, investor relations and marketing. Priyanka has a financial background with expertise in asset management. She previously served as a senior investment analyst at family office, Geller Advisors LLC, with a focus on both long-only traditional investments and private markets. Her responsibilities included sourcing new investment opportunities, providing investment manager due diligence, asset allocation research and portfolio construction. Prior to Geller, she worked at Goldman Sachs Asset Management in the Alternative Investments and Manager Selection group, where she focused on selecting best-in-class, long-only equity managers with an expertise in the international and global space, on behalf of institutional and private high net worth clients. Prior roles included serving as a domestic small-cap analyst at Bank of America Merrill Lynch and MTB Investment Advisors, respectively. Priyanka received a BA in Mathematical Economics from Brown University.

Dr. Joseph Wee - Managing Director, Singapore

Dr. Joseph Wee was appointed managing director of our Singapore operations in July 2016. Dr. Wee has over 45 years of experience as productivity and business management consultant to SMEs, MNCs, Government Linked Companies and Government Agencies. Dr. Wee has held senior management and directorship positions in over 20 companies, including 3 publicly listed companies. Dr. Wee has also served as a member of Advisory Committees appointed by Government Agencies.

https://www.usagainstalzheimers.org/ alzheimers-disease-get-facts? gclid=CjwKCAiArIH_BRB2EiwA LfbH1PHdJk_SQXGq2clnYNfEQ 2NlsrKenyAGZROG83PAjet7RzXZMC jdlhoCb8UQAvD_BwE




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