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Todos Medical Ltd. (TOMDF)

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Market Cap20.934M
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  • Todos Medical Receives FDA Certificate of Free Sale for New 5-Day Tollovid Dosing Regimen
    GlobeNewswire

    Todos Medical Receives FDA Certificate of Free Sale for New 5-Day Tollovid Dosing Regimen

    Company sees this new dosing regimen of 60 pills over 5 days as optimal for Tollovid, the Company’s 3CL protease inhibitor botanical dietary supplement that helps to support and maintain healthy immune function NEW YORK, NY, and REHOVAT, ISRAEL, May 04, 2021 (GLOBE NEWSWIRE) -- via NewMediaWire -- Todos Medical, Ltd. (OTCQB: TOMDF), a comprehensive medical diagnostics and related solutions company, today announced that the US Food & Drug Administration granted the Company a new Certificate of Free Sale for a second dosing regimen for Tollovid™ as a dietary supplement. Under the new Certificate of Free Sale, the Company is authorized to market Tollovid with a dosing regimen of 60 pills over a five-day period, equivalent to 12 pills per day. Tollovid, a potent 3CL protease inhibitor botanical product, is a dietary supplement that helps to support and maintain healthy immune function. The 3CL protease is an important part of certain coronavirus’ reproductive mechanism, and inhibiting this protease may help to support and maintain healthy immune function in the face of circulating coronaviruses. The Company sees this dosing regimen for Tollovid as optimal for supporting healthy immune function. “We were very pleased with the speed with which this dosing regimen for Tollovid was granted a new Certificate of Free by the US FDA,” said Gerald E. Commissiong, President & CEO of Todos Medical. “After a successful initial launch at The Alchemist’s Kitchen in New York City, where we gained significant feedback from customers on what worked best for them with Tollovid, we developed an upgraded dosing regimen based on the first-hand experience of customers that had a successful experience with the product. With that critical information and this new Certificate of Free Sale in hand, we are now preparing to launch Todos Medical’s branded Tollovid product into the US market via a soon to be launched website www.MyTollovid.com in a direct-to-consumer model with overnight shipping. We also intend to explore opportunities to distribute Tollovid in other areas of the world that are eagerly seeking new products that can potentially inhibit 3CL protease, and are in active discussions with distributors to bring this product forward in those markets.” The Company intends to utilize a portion of the proceeds from a recently completed $3.3 million fixed price crossover investment with Yozma Group, a venture capital firm from South Korea, to help with the Tollovid launch. With Yozma’s recent investment, Todos has raised $9.7 million in this crossover round since January 2021. In addition to the Tollovid launch, the Company is utilizing the proceeds from these investments to retire certain outstanding debts, further advance the ongoing Phase 2 clinical trial of the Company’s oral 3CL protease targeting drug candidate Tollovir™ for hospitalized COVID-19 patients, the completion of initial clinical studies for the Company’s 3CL protease targeting COVID-19 diagnostic assay Tollotest™ and general corporate purposes. For information related to Todos Medical’s COVID-19 testing capabilities, please visit www.todoscovid19.com. For COVID-19 testing inquiries, please email sales@todosmedical.com. About Todos Medical Ltd. Founded in Rehovot, Israel with offices in New York City, 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. Todos recently acquired U.S.-based medical diagnostics company Provista Diagnostics, Inc. to gain rights to its Alpharetta, Georgia-based CLIA/CAP certified lab currently performing PCR COVID testing and Provista's proprietary commercial-stage Videssa® breast cancer blood test. Todos is also developing blood tests for the early detection of neurodegenerative disorders, such as Alzheimer's disease. 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. LymPro is unique 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. Todos 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. Todos has formed a strategic partnership with Integrated Health LLC to deploy mobile COVID-19 testing in the United States. Additionally, Todos has entered into a joint venture with NLC Pharma to pursue the development of diagnostic tests targeting the 3CL protease, as well as 3CL protease inhibitors that target the reproductive mechanism of coronaviruses. 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. Todos Corporate and Investor Contact: Richard Galterio Todos Medical 732-642-7770 rich.g@todosmedical.com

  • CEO Presenting on the Emerging Growth Conference on April 28. Register here
    GlobeNewswire

    CEO Presenting on the Emerging Growth Conference on April 28. Register here

    Niche Companies in Medical, Technology, Blockchain, Leisure and more in AttendanceMIAMI, April 26, 2021 (GLOBE NEWSWIRE) -- EmergingGrowth.com a leading independent small cap media portal with an extensive history of providing unparalleled content for the Emerging Growth markets and companies announces the Schedule of the 6th Emerging Growth Conference. EmergingGrowth.com is proud to present and welcome you to the 6th Emerging Growth Conference. The Emerging Growth Conference identifies companies in a wide range of growth sectors, with strong management teams, innovative products & services, focused strategy, execution, and the overall potential for long-term growth. Register for the conference here. The schedule for April 28th from 9:30 AM until 4:00 PM is as follows: (All times are Eastern Time Zone) We may see some schedule changes on Wednesday. To stay current on the schedule, please follow us on Twitter: https://twitter.com/EmergingGrowthC 9:30 – 10:15Todos Medical Ltd. (OTCQB: TOMDF) Gerald Commissiong, CEO 10:15 – 11:00Premier Products Group Inc (OTC: PMPG) Tony Hicks, Chairman, CEO 11:00 – 11:45C-Com Satellite Systems, Inc. (OTCQB: CYSNF) (TSX-V: CMI) Leslie Klein, President and CEO 11:45 – 12:30Joint Presentation: Santo Blockchain Labs (OTC: SANP) - DNA Brands (OTC: DNAX) Adrian McKenzie, CEO DNA Brands, Frank Yglesias, CEO Santos Blockchain 12:30 – 1:00Experion Holdings (OTCQB: EXPFF) (TSX-V: EXP) Jarrett Malnarich CEO 1:00 – 1:45DSG Global (OTCQB: DSGT) Bob Silzer CEO 1:45 - 2:30Jackpot Digital Inc. (OTCQB: JPOTF) (TSXV: JJ) Jake Kalpakian, President / CEO 2:30 – 3:15Healixa, Inc. (OTC Pink: EMOR) Ian Parker, CEO 3:15 – 4:00VSBLTY Groupe Technologies (OTC Pink: VSBGF) (CSE: VSBY) Jay Hutton, President and CEO All interested in attending should visit the following link to register. You will then receive an email containing the link and time to sign into the conference. Register for the conference here. We may see some schedule changes on Wednesday. To stay current on the schedule, please follow us on Twitter: https://twitter.com/EmergingGrowthC These exciting virtual conferences are like attending an “in person” event, you can sign in and out as often as you like. About EmergingGrowth.com Founded in 2009, Emerging Growth.com quickly became a leading independent small cap media portal. Over the years, it has developed an extensive history of providing unparalleled content, in identifying emerging growth companies and markets that can be overlooked by the investment community. The next step in its evolution is the Emerging Growth Conference. About the Emerging Growth Conference The Emerging Growth conference is an effective way for public companies to present and communicate their new products, services and other major announcements to the investment community from the convenience of their office, in an effective and time efficient manner. The Conference identifies companies in a wide range of growth sectors, with strong management teams, innovative products & services, focused strategy, execution, and the overall potential for long-term growth. The audience includes potentially tens of thousands of Individual and Institutional investors, as well as Investment advisors and analysts. Thanks for participating and make sure you to follow us on Twitter and YouTube to be the first to hear updates on the Conference and when the Conferences are available for replay. All Conferences are first announced on Twitter – Follow us on Twitter All Conference replays emerge on our YouTube Channel – Subscribe to our YouTube Channel All sessions will be conducted through video webcasts and will take place in the Eastern time zone. Provided above is the current Emerging Growth Conference schedule for featured presentations. Each company’s presentations will be delivered by their executive management team. Our conference serves as a vehicle for Emerging Growth to build relationships with our existing and potential clients. Accordingly, a certain number of the presenting companies are our current clients, and some may become our clients in the future. In exchange for services we provide, our clients pay us fees in the form of cash and securities, and we may currently have, or in the future may have investments in the securities of certain of the presenting companies. Finally, certain of the presenting companies have paid us a fee to secure a presentation time slot or to present generally. The presentations to be delivered by the presenting companies (including any handouts of written materials) have not been approved, endorsed by or otherwise reviewed by EmergingGrowth.com nor should they in any way be construed to have been made in connection with an offer to sell or a solicitation of an offer to buy securities. Please consult an investment professional before investing in anything viewed on the Emerging Growth Conference or on EmergingGrowth.com. If you believe your company, product or service is at the cusp of going mainstream, or you have an idea for an “Emerging Growth” company that might fit our model, contact us here. Thank you for your interest in our conference, and we look forward to your participation in future conferences. Contact: Emerging Growth Phone: 1-305-330-1985Email: Conference@EmergingGrowth.com

  • Todos Medical Acquires Provista Diagnostics and Its Proprietary Videssa Breast Cancer Blood Test
    GlobeNewswire

    Todos Medical Acquires Provista Diagnostics and Its Proprietary Videssa Breast Cancer Blood Test

    Todos plans to commercialize Videssa in late 2021 to reduce unnecessary biopsies in the $7.19 billion mammogram naïve market and integrate it into its TBIA Platform Provista Diagnostics’ testing lab in the Atlanta, Georgia area is currently performing COVID-19 testing, that will be automated to significantly increase processing capacity Todos expects to employ testing methodologies to expand Provista’s capabilities regarding COVID variant identification NEW YORK, NY, and REHOVAT, ISRAEL, April 22, 2021 (GLOBE NEWSWIRE) -- via NewMediaWire -- Todos Medical, Ltd. (OTCQB: TOMDF), a comprehensive medical diagnostics and related solutions company, today announced that it has acquired Provista Diagnostics, Inc. Provista is a medical diagnostics company based in Alpharetta, Georgia that owns the intellectual property rights to the proprietary breast cancer blood test, Videssa®, and has a diagnostic testing laboratory currently performing COVID-19 PCR testing, primarily for the medical and entertainment industries. The breast cancer diagnostics market reached a size of over $19 Billion in 2019, according to a September 2020 market report published by Global Market Insights. In many cases, current tools often cannot provide diagnostic certainty in identifying cancerous breast masses that results in an estimated $7.19 billion of additional breast diagnostic testing, according to a 2018 study by ClinicoEconomics and Outcomes Research. Videssa was developed to provide physicians with actionable information regarding breast cancer risk in women following an inconclusive mammogram result (BI-RADS III or IV), which primarily occurs in women with dense breasts. The results provided by the test, that has demonstrated specificity of 98%+ in both women over and under the age of 50, arms physicians with a powerful tool to help guide decisions of whether to continue to monitor a low-risk patient intermittently, or whether to advance an at-risk patient immediately into a more expensive and invasive diagnostic assessment that generally includes a breast biopsy. With breast biopsies having been found to show a false-positive rate following diagnostic screening procedures as high as 71 percent in the United States according to the National Cancer Institute, the annual cost in biopsy procedures that might have been avoided is estimated to be $2.18 billion. Dr. Jorge Leon, Chief Medical and Scientific Officer for Oncology and Infectious disease for Todos Medical, commented, “Videssa is a well-positioned diagnostic blood test for breast cancer with several peer-reviewed publications in well-respected medical journals demonstrating its ability to help physicians triage patients with dense breasts who regularly show inconclusive results on mammogram, a problem affecting well over 20% of women in the United States. The Videssa test offers a novel combination of biomarkers for a cancer detection liquid biopsy by detecting the presence of inflammatory markers linked to cancer with the specificity of tumor pathway biomarkers and auto-antibodies against tumor associated antigens present in breast cancer. As we prepare to launch Videssa as an aid in the diagnosis of breast cancer following an inconclusive mammogram result by the end of 2021, we expect to work with key opinion leaders in the months ahead to expand the clinical validation of additional use cases for Videssa in preparation for launch in order to confirm the accuracy of this panel to detect early stage and recurrences of breast cancer, as well as to prove its clinical utility in the context of the management of high risk patients as well as of patients already treated and in remission. “Todos’ proprietary TBIA platform will be able to piggyback on the sample volume we anticipate generating from Videssa in order to further refine its algorithms and begin deploying our proprietary TBIA immunosurveillance blood testing assay for breast cancer, colon cancer and other cancers,” continued Dr. Leon. “We believe this strategy will allow us to dramatically accelerate the timeline of bringing TBIA into the market in the United States and allow us to scale that platform more rapidly.” Todos has already delivered and installed automated extraction systems, Tecan™ and other liquid handler machines, and 384-well PCR machines in order to help position Provista to dramatically ramp up its COVID-19 PCR testing capacity in the second quarter of 2021. The Company intends to build Provista into a highly automated lab capable of running multiple platforms in parallel in order to offer clients comprehensive testing solutions that meet their needs, especially in cancer, infectious disease, immune monitoring and Alzheimer’s disease. Provista’s lab already has ELISA and PCR testing capabilities onsite. “The acquisition of Provista gives Todos a US-based home for its proprietary diagnostic platforms in spectroscopy, flow cytometry, ELISA, PCR and next-gen sequencing,” said Gerald E. Commissiong, President & CEO of Todos Medical. “As Todos expands from being a supplier of COVID-19 testing automation and reagents to labs into a company also running its own COVID-19 testing lab, the supply chains and relationships we have built in working closely with Provista’s highly competent staff over the last year will serve us extremely well. In the immediate term, we intend to focus on expanding Provista’s COVID-19 PCR testing business and deploying new assays capable of confirming whether the viral strain of a positive COVID-19 sample is from one of the known variants, as well as building assays to help monitor long-hauler COVID-19 patients who are likely at higher risk for other diseases based on the damage inflicted on their immune system. With COVID-19 testing as the initial commercial anchor to our Provista lab strategy, we will also now be able to validate our lab-based TolloTest™ 3CL protease enzymatic assay in the US and begin deploying it to monitor this biomarker of emerging importance in COVID-19, especially in concert with clinical researchers evaluating novel anti-viral therapies for COVID-19. We expect that Provista will serve as the base for all of Todos’ operational activities in the United States going forward, including COVID-19, cancer and Alzheimer’s diagnostic tests we intend to bring into the market.” Under the terms of the Agreement, Todos acquired Provista from its private equity owner for an aggregate purchase price of $7.5 million consisting of an initial cash payment of $1.25M, the issuance of $1.5M in Todos common shares priced at $0.0512/share, the issuance of a $3.5M convertible promissory note (the “Note”) and the payment on for before July 1, 2021 of $1.25M (the “July Payment”). The Provista shares acquired by Todos shall remain in an escrow account until the July Payment is made. The Note has a maturity date of April 8, 2025 and is convertible beginning on October 20, 2021 into Todos common shares at a conversion price equal to the lesser of $0.05 or the volume weighted average price of the last 20 trading days for the common shares prior to the date of conversion. In the event that Todos uplists its common shares to a national securities exchange, the Note shall automatically be exchanged into preferred stock with a conversion price equal to the lesser of (a) $0.05, (b) the opening price on the day of the uplisting provides there is no transaction associated with the uplisting or (c) the deal price of an uplisiting transaction. For information related to Todos Medical’s COVID-19 testing capabilities, please visit www.todoscovid19.com. For testing and PPE inquiries, please email sales@todosmedical.com. About Todos Medical Ltd. Founded in Rehovot, Israel with offices in New York City, 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. 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 currently performing PCR COVID testing and Provista's proprietary commercial-stage Videssa® breast cancer blood test. The transaction is expected to close in the third quarter of 2020. Todos is also developing blood tests for the early detection of neurodegenerative disorders, such as Alzheimer's disease. 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. LymPro is unique 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. Todos 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. Todos has formed a strategic partnership with Integrated Health LLC to deploy mobile COVID-19 testing in the United States. Todos entered into a strategic partnership with Osang Healthcare to distribute the GeneFinder™ PCR kits in the United States. Additionally, Todos has entered into a joint venture with NLC Pharma to pursue the development of diagnostic tests targeting the 3CL protease, as well as 3CL protease inhibitors that target the reproductive mechanism of coronaviruses. Todos recently launched a Phase 2 clinical trial for its medical strength 3CL protease inhibiting product called Tollovir™ in hospitalized COVID-19 patients. 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. Todos Corporate and Investor Contact: Richard Galterio Todos Medical 732-642-7770 rich.g@todosmedical.com