The aim of the project is to create the world's first fully functional 3D-bioprinted Bionic Pancreas - cATMP, suitable for transplantation to patients with advanced type 1 diabetes or chronic pancreatitis. Polbionica is a Polish company that is a leader in the field of bioprinting and biomaterials. Our team consists of 25 highly qualified researchers, scientists and medical professionals whose mission is to improve the lives of patients with type 1 diabetes and patients with chronic pancreatitis. Bionic Pancreas - cATMP developed by our team consists of three-dimensional cell scaffolding and blood vessels. Both elements are printed using our patented biocarcases, which create an optimal microenvironment for pancreatic islets taken from donors or patients' own cells in the case of patients with chronic pancreatitis. The bionic pancreas can be bioprinted ‘on demand’ and stored for up to a week in a bioreactor designed by us specifically for this purpose, which allows the printed organ to be thoroughly tested for quality and safety. The bionic pancreas is able to produce insulin, glucagon and C-peptide on its own in the way that a natural pancreas transplanted from a donor would produce it. The innovation of this solution is to use advanced 3D bioprinting technology to restore patients' natural ability to regulate blood sugar levels, which ensures long-term independence from insulin injections and solves the problem of organ deficiency. Our Bionic Pancreas - cATMP with a full vascular system has completed preclinical tests on large animals (pigs) with good results and is ready to demonstrate its effectiveness in the first clinical trials in humans. In recent months, we have made significant progress in preparing our team and workspace for the project. During the development of the infrastructure, we optimized the production of biomaterials. We also generated initial market interest in biomaterials by selling them to the R&D segment through the newly created Sales and Marketing Team. With a larger patent portfolio and stronger pre-clinical data, our team is fully ready for the next stages of work. A key element of this project will be the first human clinical trial recruiting patients with type 1 diabetes or chronic pancreatitis, testing the effectiveness of the bionic pancreas as a fully functional organ. We also plan to obtain the CE mark for a biocarcase as a class III medical device and for a bioreactor as a class IIa medical device, which will confirm the compliance of our products with safety, health and environmental protection requirements. This will allow us to obtain the so-called Market Authorisation for cATMP products, i.e. full consent for the sale of bioprinting kits for organs on the European market (2028). The first commercial sale of the pancreatic bionic bioprinting kit is planned immediately after the completion of the clinical trial planned in this project. The sale will take place under the Hospital Exemption principle for Advanced Therapy Medicinal Products (ATMP). Polbionica's mission is to significantly improve the quality of life of patients with type 1 diabetes and chronic pancreatitis. Our priorities are scientific excellence and concern for the well-being of patients. We want to give millions of patients a chance at a better life by revolutionizing existing treatment standards.