Company: NCEL
Filing Date: 2025-03-03
Form Type: F-4/A
Source: 0001213900-25-018981
Chunk: 563

Company: NewcelX Ltd.
Filing Date: 2025-03-03
Form: F-4/A
Chunk 563
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 -exclusivelicense agreements and on its technological platform, which enables the proliferation of pluripotent stem cells and their differentiation into cells like the islets of Langerhans (which contain insulin -producingbeta cells and glucagon -producingalpha cells). These cells are intended for transplantation in diabetics whose beta cells are unable to produce insulin and release it in response to an increase in blood sugar. Transplantation of the cells will restore the patient’s ability to produce and release insulin biologically as needed, independently of external monitoring of the blood sugar level and regular insulin injections. Therefore, the company’s drug is intended for type 1 and type 2 diabetes patients who depend on insulin injection from an external source to maintain adequate blood glucose levels. The treatment is based on islet -likeclusters of cells produced from pluripotent stem cells. As described above, based on extensive clinical trials conducted worldwide (end of the third phase) with the help of donor islets of Langerhans, it was found that their transplantation in diabetic patients led to a cure from the disease for a fixed period (about two to three years). Since the cells in the patient’s body are unable to produce insulin and release it in response to an increase in blood sugar, when functional pancreatic tissue is transplanted, the transplanted person can again produce and release insulin as needed, independently of external monitoring of the blood sugar level and regular insulin injections. Blood sugar level monitoring is done by cells, not artificial systems (such as sensors for glucose in insulin pumps). In addition, the company is developing a technology for wrapping the islets (Delivery) that will allow protection of the islets from the immune system of the patient in whose body they will be transplanted, so that this wrapping will be a solution to the phenomenon of transplant rejection, without the need to administer drugs to weaken the patient’s immune system. The wrapped islets will be implanted in the patient’s body in a defined anatomical area containing islet -likeaggregates. According to the company, this method will make it possible to control and replace the cells, if necessary, with new cells. As the product development is completed, it will solve the problem of imbalance in diabetics, which brings long -termhealth complications. Thus, by achieving balance in blood sugar levels, there will be a stop in the deterioration of the disease and the patient’s quality of life will improve. The model developed by the company in relation to the development of the drug for