NovelStem Announces FDA Pre-Submission and EMA In Vitro Diagnostic Device Filing for Revolutionary Life-Saving, Treatment-Changing Diagnostic Device by 30%-Owned NewStem, Ltd
NewStem is the only company worldwide to develop therapeutics and diagnostics products based on haploid human embryonic stem cell research
Jerusalem, Israel and Boca Raton, Florida–(Newsfile Corp. – April 11, 2022) – NovelStem International Corp. (OTC Pink: NSTM), a biotechnology company focused on the stem cell-based technology platform developed by 30%-owned, Israel-based NewStem Ltd., today announced NewStem’s filing of a pre-submission to the FDA for a De Novo Request and an in vitro diagnostic device (IVDD) for Europe, the Middle East and Africa (EMA) for their NewStem Software Diagnostic Device. The announcement followed the company’s graduation from Illumina’s Accelerator 3rd funding cycle in March 2022.
The NewStem Software Diagnostic Device (NSDD) is a bioinformatics-based software medical device platform that provides oncologists with information regarding the presence of mutations in tumors, which may confer patient resistance to certain anti-cancer drugs. The information provided by NSDD will aid oncologists when deciding which treatment regime to apply.
Cancer is the second leading cause of death globally. Despite efforts and achievements made in treating cancer over the past several decades, resistance to anti-cancer drugs continues to be a major problem in cancer therapies. Resistance is the leading cause of relapses in cancer and one of the significant causes of death due to the disease. Drug resistance (whether pre-existing or generated after therapy) is responsible for over 90% of deaths in cancer patients receiving traditional chemotherapeutics or novel targeted drugs treatments.
NewStem is a biotechnology company established as a bio-platform for genome wide screenings based on proprietary Haploid human Embryonic Stem Cell (HhESC) technology. These cells can potentially change how we develop genetic based therapeutics and diagnostics, as they are superior to other cells used for whole genome screenings. NewStem is currently the only company worldwide to develop innovative practice-changing products based on this innovative and exclusive technology. NewStem is now raising funds to deepen its internal personnel capabilities and for further research and development of its pipeline products.
“The technology, based on our proprietary haploid cells, has changed the dogma and enables what was formerly impossible,” says NewStem founder and Chief Scientific Officer, Prof. Nissim Benvenisty. “NSDD will give oncologists a better understanding of the many variances that present challenges in the treatment of cancer and in the identification of drug-type resistance. That is unprecedented.”
About NewStem newstem.com
NewStem Ltd., a biotechnology spinoff of Yissum, The Hebrew University of Jerusalem’s technology-transfer company, has established a bio-platform for genome wide screenings based on proprietary Haploid human Embryonic Stem Cell (HhESC) technology. These cells can potentially change the way we develop genetic based therapeutics and diagnostics, as they are superior to other cells used for whole genome screenings. NewStem is currently the only company worldwide to develop innovative practice-changing products based on this innovative and exclusive technology. NewStem utilizes this bio-platform for the discovery and development of precision oncology drugs based on synthetic lethal interaction modality and for diagnostics of anti-cancer drugs resistance. NewStem’s licensed technology is based on the research of Professor Nissim Benvenisty, Director of the Azrieli Center for Stem Cells and Genetic Research at the Hebrew University. NewStem holds the intellectual property, reagents and experience required for HhESC isolation, differentiation, genetic manipulation, immunogenicity and tumorigenicity.
About NovelStem International Corp. www.novelstem.com
NovelStem owns a 30% stake in NewStem Ltd. which is advancing its novel stem-cell-based diagnostic technology for predicting patients’ resistance to cancer therapies, allowing for better, targeted cancer treatments with the potential to reduce incidents of drug resistance. The technology is also being used for genetic research related to other medical therapies.
Forward-Looking Statements
Statements in this press release and its hyperlinks may be “forward-looking statements” within the meaning of federal securities laws. The matters discussed herein that are forward-looking statements are based on current board and management expectations that involve risks and uncertainties that may result in such expectations not being realized. Actual outcomes and results may differ materially from what is expressed or forecasted in such forward-looking statements due to numerous potential risks and uncertainties, including, but not limited to, the success of NewStem’s research and future commercialization of its diagnostics utilizing human haploid pluripotent stem cells, competition in the area of genetic diagnostics, the ability to retain key personnel involved in research and development, the ability to secure appropriate regulatory approvals, and the ability to fund future investment in NewStem. Such forward-looking statements speak only as of the date on which they are made.
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NovelStem Investor Relations
Bill Jones and David Collins
Catalyst IR
(212) 924-9800
NSTM@catalyst-ir.com
NewStem Contact
Ayelet Dilion-Mashiah – CEO
NewStem Ltd.
+972-54-5725477
ayelet@newstem.com
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