PRODUCTION AND
TECHNOLOGY

PRODUCTION AND TECHNOLOGY

Developers have at their disposal all the necessary testing machines (including those that allow testing in a physiological environment) and well-established models for evaluating the properties of biomaterials.

TECHNOLOGIES

We invest a lot of money in scientific and applied research. A group of engineers and researchers working each day in order to meet the needs of doctors in the implants with the desired properties. The creation of any medical device in our company begins with the formulation of requirements for it. Close contact with medical practitioners makes it possible to get recommendations on the technical characteristics and properties of the products being developed. The key to the effectiveness and competitiveness of our products is, of course, technology. We value every development and try to improve our results. We apply the strategy of patent protection of innovations to each technological feature of a product, which consists in registering the results of intellectual activity.

CYCLE PRODUCTS

Development of manufacturing technology
Safety and biological compatibility assessment
Performance evaluation in cellular models
Performance evaluation on in vivo models
(heterotopic, then orthotopic model)
Advanced clinical trials

PHYSICAL AND MECHANICAL TESTS

Special attention is paid to the physical, mechanical and biological properties of biomaterials. The developers have all the necessary testing machines and well-established models for evaluating the properties of biomaterials.

IN VITRO TESTS

After developing a technology for cleaning or obtaining a biomaterial with the necessary characteristics, the prototype is subjected to comparative studies in vitro-tests for the rate of resorption, the ability to mineralize, the leaching of biodegradation products, and etc. The next stage of property assessment is a comparative study of the product under development and reference samples on cell lines in order to determine the degree of cytotoxicity and proliferative activity of the stem cell culture. We use two cell lines – human diploid fibroblasts and bone marrow mesenchymal stromal cells.

IN VIVO TESTS

Pre-clinical assessment of the safety and effectiveness of products in vivo is carried out in two stages. The first is a model of heterotopic implantation in laboratory animals in order to evaluate the behavior of biomaterial and the reaction of surrounding tissues. The second is the model of orthotopic implantation, the purpose of which is to evaluate the functional properties of experimental samples. Our partner is the "Center for Preclinical Research" (Penza, http://prc-penza.ru/). This is a platform for conducting preclinical tests of medical devices on biological models in conditions as close as possible to clinical ones.

Further extended clinical trials are conducted in order to evaluate the effectiveness and safety of the product being developed in the clinic. Our company actively cooperates with leading scientific and medical centers throughout the Russian Federation.