We develop and introduce into clinical practice medical devices in the field of regenerative and reproductive medicine.
Gene-activated materials in various forms and designs (granules, gels, membranes, custom implants), consisting of biocompatible materials and nucleic acid molecules, “matrices” for temporary synthesis of therapeutic protein, indicated for the regeneration of various tissues.
Bone grafting in open operations
Gene-activated material in the form of granules based on octacalcium phosphate and plasmid DNA molecules with the vascular endothelial growth factor (VEGF) gene.
The device is intended to be used as an osteoplastic material for “augmentation” of jaw bone tissue prior to the subsequent dental implantation or during the placement of dental implants, as well as for the bone defect restoration in traumatology and orthopedics.
The carrier matrix for plasmid DNA molecules is completely synthetic, which allows the device to be used in all patients, regardless of their religious and ethical beliefs.
The medical device is available in two main sizes (small and large granules) and various packaging configurations.
Bone grafting in open operations
Gene-activated material in the form of granules based on xenogeneic bovine bone matrix and plasmid DNA molecules with the vascular endothelial growth factor (VEGF) gene.
The device is intended to be used as an osteoplastic material for “augmentation” of jaw bone tissue prior to the subsequent dental implantation or during the placement of dental implants, as well as for the bone defect restoration in traumatology and orthopedics.
The carrier matrix for plasmid DNA molecules is a product of animal origin, corresponding to the mainstream trend in osteoplastic materials in the dental market segment.
The medical device will be available in two sizes (small and large granules) and various packaging configurations."
Minimally invasive bone grafting
Gene-activated material in the form of granules based on xenogeneic bovine bone matrix, hyaluronic acid-based hydrogel, and plasmid DNA molecules with the vascular endothelial growth factor (VEGF) gene.
The device is highly hydrophilic and can be injected during any osteoplastic surgery, including minimally invasive ones: in dentistry, maxillofacial surgery, traumatology, and orthopedics.
The carrier matrix for plasmid DNA molecules is a product of animal origin, corresponding to the mainstream trend in osteoplastic materials in the dental market segment.
The medical device will be delivered in disposable syringes.
Damage to skin and mucous membranes
Injectable gene-activated material based on hyaluronic acid hydrogel and plasmid DNA molecules with the vascular endothelial growth factor (VEGF) gene.
The device is being studied in the field of regeneration of skin, mucous membranes, and striated skeletal muscle tissue through topical and injection routes. In vitro and in vivo data on the effectiveness of delivery of gene constructs have been obtained, as well as early “proof-of-concept” experimental data in relevant animal models.
The medical device will be delivered in disposable syringes.
Filling Large Bone Defects
Gene-activated material in the form of custom implants manufactured using 3D printing technology, with plasmid DNA molecules with the vascular endothelial growth factor (VEGF) gene.
The device is designed for the reconstruction of skeletal bones in maxillofacial surgery, traumatology, orthopedics, and neurosurgery. Manufacturing for each individual patient makes it a product as a service. Customizable geometry of the implants will ensure easy and quick use during surgery.
Directed bone regeneration, fixation of granular materials in bone grafting, oral mucosa grafting
Gene-activated material based on a collagen matrix and plasmid DNA molecules with the vascular endothelial growth factor (VEGF) gene.
Various methods for producing a collagen-based carrier matrix, including electrospinning are being developed, the best options for various indications in terms of their biomechanical properties and biodegradation rate are being selected, and early in vivo experimental proof-of-concept studies are under way.
The medical device will be available as hydrophilic membranes of various sizes and thicknesses.
An auxiliary product for bone grafting
Dental scraper. A device for exposing bone tissue of a patient.
Development of NGS-based assays for screening and genetic diagnostics in reproductive medicine and oncology.
Prenatal screening of pregnant women
A reagent pack for sample preparation and sequencing of freely circulating DNA obtained from blood samples of pregnant women designed to determine the risk of aneuploidy at chromosomes 13, 18, 21, X, Y of the fetus. It also includes data processing software and an algorithm for calculating the risk from cell-free DNA sequencing data.
The assay is intended to be used in medical and research genetic laboratories to conduct tests for chromosomal abnormalities in the fetus in the early stages of pregnancy."
Preimplantation genetic testing
A reagent pack for sample preparation and sequencing of trophectoderm samples of an embryo on the fifth day of development designed to increase the probability of pregnancy in an IVF cycle. It also includes software algorithms for processing data from NGS sequencing of embryo cell DNA whole-genome amplification products, making it possible to determine the main genomic mutations of the fetus (trisomy, monosomy, tetrasomy, nullisomy, segmental copy number variations).
The assay is intended to be used in medical and research genetic laboratories to analyze chromosomal abnormalities in the fetus.
Genetic profiling of the tumor
A panel (primer set) for sequencing DNA isolated from tumor tissue to identify molecular changes in the genes associated with the development of various tumor types and the response to target therapy, as well as a developed software algorithm for processing and clinical interpretation of sequencing data.
The panel is intended to be used in medical and research laboratories for the purpose of molecular genetic profiling of tumors and personalized selection of target therapy for cancer patients."
Suspicion of hereditary disease
Whole exome sequencing is the part of the human genome responsible for protein synthesis in the body.
Whole-exome sequencing is a DNA test that is used when a patient is suspected of having an inherited disease to clarify the diagnosis, predict the course of the disease, or determine the genetic cause of the disease.
Whole-exome sequencing is also used for pre-conceptional screening, which is designed to reduce the risk of an inherited disease in future children.
Translated with DeepL.com (free version)