Company: NCEL
Filing Date: 2025-06-23
Form Type: F-4/A
Source: 0001213900-25-056787
Chunk: 385

Company: NewcelX Ltd.
Filing Date: 2025-06-23
Form: F-4/A
Chunk 385
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 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 -102demonstrated 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 -likecell clusters (IsletRx Plus); encapsulated in alginate microgels, intended for intra -peritonealimplantation. The alginate microencapsulation enables implanting of IsletRx Pluscells without the need of chronic immunosuppression treatment. Still, IsletRx Pluscells are not in direct contact with the vasculature, and may suffer from hypoxia and loss of function due to fibrosis. The 209 retrievability of microencapsulated IsletRx Pluscells is a regulatory concern, as there is very limited data about the safety of stem cells -derivedislets. Preclinical efficacy studies using Encap -IsletRx Plusdemonstrated prolong anti -diabeticeffect, with physiological secretion of human insulin in a glucose dependent manner. In -Scaffold-IsletRx PlusHuman pluripotent (embryonic) stem cell -derivedpancreatic islet -likecell clusters (IsletRx Plus); encapsulated in alginate microgels embedded in electro spun polycaprolactone membrane, intended for subcutaneous implantation. The alginate microencapsulation enables implanting of IsletRx Pluscells without the need of chronic immunosuppression treatment. The embedding of the microcapsules in a membrane makes it