Todos Medical Ltd. is an in-vitro diagnostic company engaged in the development of blood tests for the early detection of a variety of cancers, and also 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.
Todos 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 and plasma. This proprietary and patented method incorporates biochemistry, physics and signal processing.
Our Behind the Buzz Show Featuring Todos Medical Ltd.
Jan. 09, 2020 - Todos Medical Enters into Exclusive Option Agreement to Acquire Provista Diagnostics and Announces Management Changes
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, today announced that it has entered into an exclusive option agreement to acquire Provista Diagnostics, Inc., an in vitro diagnostics company with a CLIA/CAP certified lab in Alpharetta, Georgia, developing and commercializing the proprietary Videssa® blood test for breast cancer. Videssa has been clinically validated for the early and accurate detection of breast cancer based on data from over one thousand patient samples.
“The Videssa technology platform and the menu of cancer and autoantibodies tests from Provista Diagnostics represent a robust, reliable, cost- effective and clinically useful line of products for the early and accurate detection of breast cancer,” said Dr. Jorge Leon, Senior Medical Advisor of Todos. “Once confirmed through a clinical utility study to support reimbursement in breast cancer and bench marking, this pipeline of tests can play a real role in the management of cancer patients worldwide.”
“We are excited to be joining forces with Todos Medical and leveraging the combined knowledge and capabilities of our respective technologies to advance the early detection of breast cancer and other women’s cancers,” said Uriel E. Kusiatin, CEO, Provista Diagnostics. “Provista’s expertise in conducting rigorous prospective clinical trials; clinical validation and the publication of results in peer reviewed journals; as well as our commercial expertise from piloting commercial efforts with approx. 150 providers, gives us a distinct advantage as we position ourselves as the leaders in the space. I look forward to continuing to work with Todos Medical’s leadership to develop best in class diagnostics.”
Concurrent with this announcement, the Company announced that it has appointed Gerald Commissiong, a US-based executive, as Chief Executive Officer, and that it has appointed Daniel Hirsch, an Israeli-based executive of American descent, as Chief Financial Officer. Mr. Commissiong and Mr. Hirsch have been tasked with effectuating the relocation of Todos from Israel to the US so that the Company can focus its development and commercialization efforts of its proprietary Total Biochemical Infrared Analysis (TBIA) cancer diagnostic platform in the United States. Todos’ former CEO, Dr. Herman Weiss, will remain with the Company as Chairman of the Board.
“I am excited about the opportunity to lead the effort to refocus Todos’ efforts on the US market,” said Gerald Commissiong, Chief Executive Officer of Todos. “The TBIA platform developed in Israel has resulted in a CE Mark for breast cancer tests in Europe, where Orot+ (the operational division of www.orot-luces.com) is currently enrolling patients in a commercial validation study to support the commercial launch of the TM-B1 and TM-B2 blood tests later this year. With the pending acquisition of Provista that will give Todos ownership of a CLIA/CAP certified lab and Videssa that has already been validated and commercialized in the United States, we believe that we are positioning Todos to become the premier breast cancer blood testing company, with the potential to expand that leadership position to all cancers.”
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. Mr. Hirsch has 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.
For Full Release: https://www.globenewswire.com/news-release/2020/01/09/1968392/0/en/Todos-Medical-Enters-into-Exclusive-Option-Agreement-to-Acquire-Provista-Diagnostics-and-Announces-Management-Changes.html
Nov. 14, 2019 - Todos and Amarantus JV Announces Full Enrollment for Clinical Trial of LymPro Alzheimer’s Blood Test Relationship with Amyloid PET
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, and Amarantus Bioscience Holdings, Inc. a US-based JLABS-alumnus biotechnology holding company developing proprietary orphan neurologic, regenerative medicine and ophthalmic therapies and diagnostics through its subsidiaries, today announced that their joint venture company, Breakthrough Diagnostics, Inc. has completed enrollment of its ongoing clinical trial evaluating the relationship of Alzheimer’s blood diagnostic Lymphocyte Proliferation Test (LymPro Test™) with amyloid PET neuroimaging at Leipzig University in Germany (the ‘LymPro PET 2’). Topline results are expected before the end of the first quarter of 2020.
Breakthrough completed a 20-subject clinical study (LymPro PET 1) in 2018 evaluating the correlation between LymPro scores and the diagnosis of Alzheimer’s disease, as confirmed with amyloid PET neuroimaging and other Alzheimer’s disease biomarkers. LymPro measures cell cycle dysregulation in peripheral lymphocytes. The top-line data, announced in July 2019, revealed a strong and statistically significant correlation between LymPro scores and amyloid PET neuroimaging cSUVR scores (r = -0.849; p = 0.00000216). Breakthrough’s academic collaborators at the Leipzig University then expanded enrollment of that study to include an additional cohort of 20 subjects (LymPro PET 2) to confirm the strong relationship seen from LymPro PET 1. The data from both LymPro 1 and LymPro 2 will be published together in a peer-reviewed journal in 2020.
“LymPro is a unique immune system-based Alzheimer’s blood test,” said Dr. Herman Weiss, President & CEO of Todos. “LymPro could prove to be a major breakthrough for Alzheimer’s disease diagnosis by measuring cell cycle dysregulation and amyloid, together, conveniently as part of a blood workup in routine clinical practice. The therapeutic field in Alzheimer’s has begun to see some renewed hope based upon recent Aducanumab data announced by Biogen that is directly related to the amyloid hypothesis, as well as conditional approval by the National Medical Products Administration in China for the first new Alzheimer’s drug in over 20 years, called Oligomannate from Shanghai Green Valley Pharmaceuticals, that is based on gut-brain biology of the microbiome and its effects on the immune system. We believe this renewed optimism and broadening of pathophysiological hypotheses relevant to Alzheimer’s disease being evaluated in the clinic significantly increases the scope for LymPro pharma services collaborations and begins to refine LymPro’s clinical utility profile for primary care physicians as strategies to correct cell cycle dysregulation emerge.”
About Alzheimer’s Disease
According to the Alzheimer’s Association, it is estimated that over 5.4 million people in the United States suffer from Alzheimer’s disease. Over 500,000 patients are diagnosed annually, with nearly one-in-eight older Americans affected by the disease. Alzheimer’s disease is the third leading cause of death in the United States. The cost of unpaid care in the United States is estimated at over $210 billion annually. Total payments for care are estimated at over $200 billion annually, including $140 billion in cost to Medicare and Medicaid. Alzheimer’s expenditures in the United States are expected to exceed $1.2 trillion by 2050. There is no cure or effective treatment for Alzheimer’s disease. Worldwide, about 35.6 million individuals have the disease and, according to the World Health Organization, the number will double every 20 years to 115.4 million people with Alzheimer’s by 2050.
About Dr. Arendt’s Research at Leipzig University
Dr. Thomas Arendt is Professor of Neuroscience at Leipzig University where he runs the Paul Flechsig Institute of Brain Research. He has a 30-year record in R&D of therapeutic and diagnostic strategies of neurodegenerative disorders and made several seminal contributions to therapeutic concepts of Alzheimer’s disease, including stem cell therapy and modulating tumor suppressor genes. In the early 1980’s, he was involved in identifying the degeneration of the cholinergic system in Alzheimer’s disease laying the basis for today’s only available treatment. He is one of the pioneers of the “cell-cycle theory” of Alzheimer’s disease, which he developed towards a diagnostic and therapeutic concept.
About Breakthrough Diagnostics, Inc.
Breakthrough Diagnostics, Inc. is a joint venture owned by Amarantus Bioscience Holdings, Inc. (OTCPK: AMBS) (80.01%) and Todos Medical Ltd. (19.99%). Breakthrough has been assigned the intellectual property and other rights to the LymPro Test®, a diagnostic blood test for Alzheimer’s disease, as well as rights to other neurological diagnostics testing intellectual property. Todos Medical has provided Amarantus with notice of Todos’ decision to exercise its exclusive option to acquire the 80.01% of Breakthrough Diagnostics that it currently does not own.
The Lymphocyte Proliferation Test (LymPro Test™) 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 surrogates for neuronal cell function, suggesting a common relationship between PBLs and neurons in the brain.
For Full Release: https://www.globenewswire.com/news-release/2019/11/14/1947429/0/en/Todos-and-Amarantus-JV-Announces-Full-Enrollment-for-Clinical-Trial-of-LymPro-Alzheimer-s-Blood-Test-Relationship-with-Amyloid-PET.html
Oct. 24, 2019 - Todos Medical to Present at Dawson James Small Cap Growth Conference
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, today announced that Company management will present at the Dawson James Small Cap Growth Conference on Tuesday, October 29, 2019 beginning at 3:15 P.M. Eastern time. The conference will be held October 28-29 at the Wyndham Grand Jupiter at Harbourside Place in Jupiter, Florida.
About Todos Medical Ltd.
Todos Medical Ltd. is an in-vitro diagnostic company engaged in the development of blood tests for the early detection of a variety of cancers, and also 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. Todos 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 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, have received the CE mark. Breakthrough Diagnostics is developing the LymPro Test®, a blood test for diagnosing Alzheimer’s disease.
Sept. 24, 2019 - Todos Medical and Orot+ Announce First Patient Enrolled in Pre-Commercial Launch Preparations of TM-B1 and TM-B2 Breast Cancer Blood Screening Tests in Europe
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, and Orot+, the operational division of Orot-Luces (http://orot-luces.com), that executed a distribution agreement with Todos for the commercial distribution of Todos’ TM-B1and TM-B2 blood screening tests for breast cancer, today announced the enrollment of the first patient in the pre-commercial launch study of TM-B1 and TM-B2 in Europe. The pre-commercial launch study is expected to last approximately 6 months. Upon completion of the pre-commercial launch study, TM-B1 and TM-B2 are expected to be available for commercial sale in Romania by Orot. Orot is providing full funding for the pre-commercial launch study as well as the commercial launch in accordance with the terms of the exclusive distribution agreement.
“In accordance with the exclusive distribution agreement for both our TM-B1 and TM-B2 breast cancer screens in Romania and Austria executed in April 2019, Orot has commenced screening of patients as part of the agreed upon pre-sale preparation study required to support commercial launch in Romania. We are excited to achieve this critical milestone along our path to full commercialization in Europe,” said Dr. Herman Weiss, President & CEO of Todos Medical. “Our blood tests are designed to screen for the presence of breast cancer at early stages of disease, and we know that early diagnosis and treatment greatly improves patient outcomes.”
“The initiation of the pre-commercial study of Todos Medical’s TM-B1 and TM-B2 breast cancer blood screening tests will help create awareness among the medical community and local patient population of an affordable test that addresses the unmet need for improved breast cancer screening,” said Mr. Ron Streichman, CEO of Orot-Luces. “We have received encouraging feedback from medical practitioners and expect this to continue as they become aware of the significant potential for improved patients outcomes based upon the data generated in this patient population.”
About TM-B1 and TM-B2 Breast Cancer Blood Tests
The Company’s two breast cancer screening tests, TM-B1 and TM-B2, have received CE mark to support commercialization in Europe. In April 2019, the Company entered into an exclusive distribution agreement with Orot+, the operational division of Orot-Luces (http://orot-luces.com), to support the commercial distribution and marketing of TM-B1 and TM-B2 in Romania and Austria. In August 2019, Orot and Todos entered into a memorandum of understanding to expand the territories under the distribution agreement to include Japan.
The TM-B1 assay is indicated for women aged 25 years and older without a diagnosis of inflammatory disease. The assay is intended to be used as a diagnostic method to indicate whether or not a breast malignancy is present. TM-B1 results are initially intended to be used in conjunction with other common diagnostic tests as part of breast cancer screening. In our latest clinical trial, the TM-B1 assay showed a sensitivity of 86% and a specificity of 98%. Positive predictive value was 95.1% and negative predictive value was 93.5%.
The TM-B2 assay is indicated for women who meet the following criteria: Female subjects, aged 25 years and older, without a diagnosis of inflammatory or autoimmune disease and who were diagnosed as presenting with BI-RADS score of 3 or 4 (or equivalent). TM-B2 is to be used to further assess if a malignancy is present or not. TM-B2 results are initially intended to be used in conjunction with other common diagnostic tests as part of breast cancer screening. In our latest clinical trial, the TM-B2 assay showed a sensitivity of 83% and a specificity of 99%.
For Full Release: https://www.globenewswire.com/news-release/2019/09/24/1919996/0/en/Todos-Medical-and-Orot-Announce-First-Patient-Enrolled-in-Pre-Commercial-Launch-Preparations-of-TM-B1-and-TM-B2-Breast-Cancer-Blood-Screening-Tests-in-Europe.html
Sept. 13, 2019 - Todos Medical Signs Binding Term Sheet with HWH World for Network Marketing of Blood Tests for the Early Detection of Breast Cancer
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, today announced it has entered into a binding term sheet with HWH World Pte Ltd. (“HWH World”), a wholly-owned subsidiary of Singapore eDevelopment (SGX:40V) for the grant of exclusive marketing rights for Todos Medical’s TM-B1 and TM-B2 tests to HWH World’s network of members in Singapore, Malaysia, the Philippines, Vietnam, Thailand, Indonesia, South Korea, Hong Kong, China, the United States and Canada. HWH World is a marketing firm that focuses on health and wellness. HWH World will work closely with Todos Medical to achieve regulatory approval in Singapore, where Todos Medical recently completed clinical studies, and thereafter expand into other markets. Todos remains free to partner with other companies to market and distribute its diagnostic tests through traditional means, including direct to consumer, through physicians, hospitals and/or government health systems.
“Todos Medical’s innovative artificial intelligence-based blood testing technology has shown strong results for breast cancer screening and diagnosis in Singapore,” said Heng Fai Chan, Chairman of HWH World. “This represents a tremendous opportunity for HWH World members to take control of their healthcare by getting better information about potential cancer to ensure they are seeking treatment early in the disease progression. This will improve the well-being of our female members and help differentiate us from other wellness programs in the market. Many Asian women are forced to have unnecessary breast biopsies because mammograms are not very effective in this population. Todos has identified a solution to this problem, and HWH World is looking forward to bringing the TM-B1 and TM-B2 tests to our members both in Asia and as we expand into North America.”
“Having just completed a substantial clinical study in Singapore that demonstrated the superiority of our assay versus mammography in prospectively classifying cancer and non-cancer subjects, especially among those with inconclusive mammogram results (BI-RADS III/IV), we are pleased to secure our first Asian partner in HWH World. Our two companies are aligned in viewing the significant value by utilizing a blood test that will determine whether a biopsy is necessary in breast cancer,” said Herman Weiss, M.D., President and CEO of Todos Medical.
For Full Release: https://www.globenewswire.com/news-release/2019/09/13/1915349/0/en/Todos-Medical-Signs-Binding-Term-Sheet-with-HWH-World-for-Network-Marketing-of-Blood-Tests-for-the-Early-Detection-of-Breast-Cancer.html
Sept. 03, 2019 - Todos Medical Enters into MOU to Expand Existing Early Detection Breast Cancer Blood Test Distribution Partnership with Orot+ into Japan
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, today announced that the Company has entered into a non-binding Memorandum of Understanding (MOU) with Orot+, the operational division of Orot-Luces (http://orot-luces.com), to expand their existing launch and distribution partnership for the commercial sale of Todos’ early breast cancer detection blood tests TM-B1 and TM-B2 into Japan.
Under the terms of the MOU, Orot+ has agreed to spend a minimum of $2.5M towards clinical development, regulatory approval and commercial launch of the tests by way of a soon to be formed Japanese Distribution Company which will be granted the exclusive rights to sell and distribute TM-B1 and TM-B2 in Japan. The execution of this MOU expands the relationship between Todos and Orot+, as the companies signed a definitive exclusive distribution agreement for both of TM-B1 and TM-B2 in Romania and Austria in April 2019.
“We are excited to expand our commercialization network for TM-B1 and TM-B2 into Japan, and are especially happy we are again partnering with Orot+, who will drive the market launch and distribution efforts. Our blood tests are designed to detect the presence of breast cancer at early stages of disease, and we know that early diagnosis and treatment greatly improves patient outcomes,” said Dr. Herman Weiss, President & CEO of Todos Medical. “Japan, like much of Asia, has an enhanced need for alternatives to mammogram as the primary breast cancer diagnostic, due to the high incidence of women with dense breast tissue, making this an especially important market for us.”
“We are satisfied that Todos has recognized our unique market position and decided to partner with us to launch their cancer detection blood test in the Japanese market. While Japan has the worlds second largest economy, there are serious unmet needs in cancer care. Orot is focused on offering unique and customized diagnostic solutions,” said Mr. Ron Streichman, CEO of Orot-Luces.
For Full Release: https://www.globenewswire.com/news-release/2019/09/03/1910303/0/en/Todos-Medical-Enters-into-MOU-to-Expand-Existing-Early-Detection-Breast-Cancer-Blood-Test-Distribution-Partnership-with-Orot-into-Japan.html
Aug. 06, 2019 - Todos Medical Appoints Dr. Jorge Leon as Medical Advisor
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 the appointment of Jorge Leon, PhD, as a medical advisor to assist the Company in clinical development, regulatory strategy and fund raising. Dr. Leon is an in-vitro diagnostics expert, having served as a key executive in the establishment of what is now known as Quest Diagnostics.
“The importance of early disease detection cannot be overstated, and the earliest signs of disease often appear when looking at the immune system,” said Dr. Leon, newly appointed medical advisor to Todos. “Todos’ cancer and Alzheimer’s platforms have been developed with the specific intention of being able to measure fundamental disease pathology in the immune system at the earliest stages. I am excited to work closely with the team being assembled to help drive clinical and regulatory execution so that these early disease screening platforms can reach their full commercial potential, with an initial focus on early adoption along key constituencies in the US and abroad. The early detection of cancer would dramatically improve patient outcomes, and the early detection of Alzheimer’s disease is the key unmet need to drive research investment towards altering the underlying course of disease progression before it becomes too late to intervene.”
“Dr. Leon’s track record speaks for itself in terms of his accomplishments and contributions to the field of human diagnostics by dramatically improving patient access to cutting edge diagnostics technologies,” said Dr. Herman Weiss, President & CEO of Todos Medical. “We are excited to bring Dr. Leon onto the team at Todos as we are preparing to launch our TBIA cancer platform in Europe and Israel, as well as assisting biopharmaceutical companies in their quest to develop new therapeutics for Alzheimer’s. His expertise and relationships will be instrumental to Todos’ progress as we move forward.”
Dr. Jorge Leon is internationally recognized for his pioneering work in molecular diagnostics. Dr. Leon 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 NYC. 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. Jorge 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 twelve 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. Jorge Leon and his experienced team 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.