Todos Medical, 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. 

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