NovelStem Announces FDA Pre-Submission and In Vitro Diagnostic Device Filing with EMA for Breakthrough Diagnostic Device to Save Lives and Change Treatment by 30-Owned NewStem, Ltd. %


NewStem is the only company in the world to develop therapeutic and diagnostic products based on haploid human embryonic stem cell research.

Jerusalem, Israel and Boca Raton, Fla.–(Newsfile Corp. – April 11, 2022) – NovelStem International Corp. (OTC pink: NSTM), a biotechnology company specializing in the stem cell-based technology platform developed by NewStem Ltd., 30% based in Israel, today announced that NewStem has filed a pre-submission with the FDA for an application for Novo and an in vitro diagnostic device (IVDD) for Europe, the Middle East and Africa (EMA) for their NewStem software diagnostic device. The announcement follows the company’s exit from Illumina’s 3rd round of Accelerator funding in March 2022.

The NewStem Software Diagnostic Device (NSDD) is a bioinformatics-based medical device software platform that provides oncologists with information regarding the presence of mutations in tumors that may confer resistance to certain cancer drugs in the patient. The information provided by the NSDD will help oncologists decide which treatment regimen to apply.

Cancer is the second leading cause of death worldwide. Despite the efforts and achievements made in the treatment of cancer over the past decades, resistance to cancer drugs continues to be a major problem in cancer therapies. Resistance is the leading cause of cancer relapse and one of the leading causes of death from the disease. Drug resistance (whether pre-existing or generated after treatment) is responsible for over 90% deaths in cancer patients receiving traditional chemotherapy or new targeted drug treatments.

NewStem is a biotechnology company established as a bio-platform for genome-wide screens based on proprietary haploid human embryonic stem cell (HhESC) technology. These cells can potentially change the way we develop genetic-based therapies and diagnostics, as they are superior to other cells used for whole-genome screens. NewStem is currently the only company in the world to develop innovative, practice-changing products based on this innovative and exclusive technology. NewStem is currently raising funds to deepen the capabilities of its internal staff and to continue the research and development of its products under development.

“The technology, based on our proprietary haploid cells, has changed dogma and enables what was previously impossible,” says NewStem Founder and Chief Scientific Officer, Professor Nissim Benvenisty. “NSDD will give oncologists a better understanding of the many variances that present challenges in cancer treatment and in identifying drug-like resistance. It is unprecedented.

About NewStem

NewStem Ltd., a biotechnology spin-off company from Yessum, the Hebrew University of Jerusalem’s technology transfer company, has established a bio-platform for genome-wide screens based on proprietary human haploid embryonic stem cell (HhESC) technology. These cells have the potential to change the way we develop gene-based therapies and diagnostics because they are superior to other cells used for whole-genome screens. NewStem is currently the only company in the world to develop innovative, practice-changing products based on this innovative and proprietary technology. NewStem uses this bio-platform for the discovery and development of precision oncology drugs based on the synthetic lethal interaction modality and for the diagnosis of anti-cancer drug resistance. NewStem’s licensed technology is based on research by Professor Nissim Benvenisty, Director of the Azrieli Center for Stem Cells and Genetic Research at the Hebrew University. NewStem owns the intellectual property, reagents and experience necessary for the isolation, differentiation, genetic manipulation, immunogenicity and tumorigenicity of HhESCs.

About NovelStem International Corp.

NovelStem holds a 30% stake in NewStem Ltd., which is advancing its novel stem cell-based diagnostic technology to predict patient resistance to cancer therapies, enabling better targeted cancer treatments with the potential to reduce incidents of drug resistance. The technology is also used for genetic research related to other medical therapies.

Forward-looking statements

The statements contained in this press release and its hyperlinks may be “forward-looking statements” within the meaning of the federal securities laws. The matters discussed herein that are forward-looking statements are based on the current expectations of the board of directors and management that involve risks and uncertainties that could cause those expectations not to be realized. Actual results and outcomes may differ materially from what is expressed or anticipated in these forward-looking statements due to numerous potential risks and uncertainties, including, but not limited to, the success of NewStem’s research and the future commercialization of its diagnostics using the human haploid pluripotent stalk. cells, competition in the field of genetic diagnostics, the ability to retain key personnel involved in research and development, the ability to obtain appropriate regulatory approvals and the ability to fund future investments in NewStem. These forward-looking statements speak only as of the date they are made.

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NovelStem Investor Relations
Bill Jones and David Collins
IR catalyst
(212) 924-9800
[email protected]

Contact NewStem
Ayelet Dilion-Mashiah – CEO
NewStem Ltd.
[email protected]

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