On April 11, 2022 Bio-Platform NewStem Ltd reported the filing of a pre-submission to the FDA for a De Novo Request and an in vitro diagnostic device (IVDD) for EMA for their NewStem Software Diagnostic Device (Press release, NewStem, APR 11, 2022, View Source [SID1234612062]). The announcement followed the company’s graduation from Illumina’s Accelerator 3rd funding cycle in March 2022.
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The NewStem Software Diagnostic Device (NSDD), a bioinformatics-based software medical device platform, 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 Cells (HhESCs) 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. The company is now raising funds to deepen its internal personnel capabilities and for further research and development.
"The technology, based on our proprietary haploid cells, has changes the dogma and enables what was formerly impossible", says 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."