Company: NCEL
Filing Date: 2025-03-03
Form Type: F-4/A
Source: 0001213900-25-018981
Chunk: 274

Company: NewcelX Ltd.
Filing Date: 2025-03-03
Form: F-4/A
Chunk 274
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, while maintaining their vitality and pluripotent fitness. This technology enables the production and storage of industrial -scalestock of pluripotent stem cells, which can then be thawed and used in production and differentiated into specific cell lineage as needed. Differentiation:Kadimastem has developed technology and know -how, through which the technology can mimic the process of embryonic development and direct the pluripotent stem cells to differentiate into a specific lineage in the body, according to choice and relevant needs. The differentiation process is carried out under laboratory conditions, in several stages, by adding chemical and/or biological agents in controlled timings to the pluripotent stem cell culture. Induction of differentiation processes of pluripotent stem cells into islet -likecell clusters, under laboratory conditions is conducted in a stirred suspension bioreactor under conditions that mimic the development of the pancreatic islets. Enrichment:Kadimastem has developed an enrichment technology which it believes improves safety and efficacy of IsletRx cells. The IsletRx cells are enriched for insulin secreting cells, designated as IsletRxPlus, and formulated as the drug substance. Delivery:Several delivery strategies were developed to obviate the need for life -longimmunosuppressive treatment while enabling the long -termfunction of IsletRxPlus cells. These strategies include immune tolerance, microencapsulation in polymer, and scaffolding using electrospinning of polycaprolactone. The cellular component in all products is the same, IsletRx Pluscells. Products description iTOL -102Human pluripotent (embryonic) stem cell -derivedpancreatic islet -likecell clusters (IsletRx Plus); mixed with SA -FasLMicrogels (iTOL -100), intended for omental implantation. The iTOL100 enables implanting of IsletRx Pluscells without the need of chronic immunosuppression treatment. Thus, IsletRx Pluscells are in direct contact with the omental vasculature, ensuring proper engraftment and function. Preclinical efficacy studies using iTOL -102 140 demonstrated prolonged anti -diabeticeffect, with physiological secretion of human insulin in a glucose dependent manner. These results, along with the proof of concept, or POC, studies with an iTOL100 component, have led to submission of a Pre -INDpackage. Encap -IsletRx PlusHuman pluripotent (embryonic) stem cell -derivedpancreatic islet -like