Gistograft

Gene-activated materials

To treat patients with injuries to the musculoskeletal system, skin, internal organs, various biocompatible materials are often used. However, the effectiveness of most of them remains insufficient, since they do not contain biologically active components that stimulate tissue regeneration and organ repair. According to the company's employees, a new class of medical devices - gene-activated materials - will solve this problem. A distinctive feature of these products is the presence in their composition of biologically active nucleic acids encoding key growth factors, the production of which must be temporarily increased in order to enhance the activity of the reducing process. The technology and products developed by Histograft are protected by a number of Russian and foreign patents.

Partners of the company

The key partners of the company are PJSC "Human Stem Cell Institute" and NekstGen LLC (resident of the Skolkovo Foundation). A number of projects of the Company are carried out in cooperation with teams of leading scientific and educational institutions: A.A. Baykova Institute of Metallurgy and Materials Science, Russian Academy of Sciences (Moscow), Kazan (Volga) Federal University (Kazan), I.P. Pavlova Ryazan State Medical University (Ryazan), University of Leeds (Leeds, UK). One of the company's projects, dedicated to the development of optimized gene-activated osteoplastic materials, was supported by the Foundation for the Development of Small Forms of Enterprises in the Scientific and Technical Sphere under the START-1 program (contract No. 1622 GS1/24341 dated October 21, 2016).

History

2022: Sale of controlling stake to Human Stem Cell Institute

The Human Stem Cell Institute (ISKCH) bought a controlling stake in the biotechnology company Histograft, which was announced in April 2022. The total amount of investments calculated for 2022-2023 is 50 million rubles. At the same time, the share that ISCH received in the startup is not specified.

The funds invested in Histograft will be used to complete the development, registration and launch into the Russian market of five more products, candidates for which have already shown safety and effectiveness in pre-clinical studies.

Human Stem Cell Institute (ISCH) bought a controlling stake in the biotechnology company Histograft

Our material in terms of efficiency and level of technologies is ahead of leading foreign competitors. Against the background of current events, the cost of imported products has increased significantly and domestic manufacturers have gained advantages, says Ilya Bozo, director of Histograft. - Histograph "fully began to realize the possibilities of import substitution. The view of many specialists turned to him - we have sharply increased demand.

By April 2022, Histograft produces and introduces into clinical practice gene-activated material for bone tissue regeneration. The material is octacalcium phosphate granules with plasmid DNA molecules with vascular endothelial growth factor (VEGF) gene applied to them. The granules serve as a matrix for forming bone tissue, and DNA enhances blood supply and bone regeneration in the surgery zone. The material simplifies the execution of bone plastics, minimizes the use of the patient's own bone tissue, and brings the treatment results to a qualitatively new level. Gene-activated matrices are an innovative scientific and technical direction developed and first introduced into clinical practice by the Histograft team together with ISCH and the Institute of Metallurgy and Materials Science of the Russian Academy of Sciences.^[1]

2021: Attracting 37.7 million rubles of investment

On January 22, 2021, the Human Stem Cell Institute (ISCH) announced the investment of 37.7 million rubles in Histograft. The Russian developer of bone tissue regeneration technologies plans to spend the funds raised to introduce new materials for bone plastics into clinical practice.

According to the ISKCH press release, in addition to the direct institute, the chairman of the board of directors of ISKCH Arthur Isaev invested in the startup. Moreover, he provided most of the amount - almost 22.76 million rubles.

Histograft attracted 37.7 million rubles

The terms of the agreement also provide for the use of patents protecting intellectual property associated with gene-activated matrices.

By January 2021, Histograft and ISCH, together with the Institute of Metallurgy and Materials Science of the Russian Academy of Sciences, are developing materials containing DNA of growth factors. Partners plan to introduce into clinical practice gene-activated products in the form of gel, membrane and personalized implants made using 3D printing technologies. ISKCH and Histograft have a number of joint patents and a license agreement for their use.

Earlier, Histograft received support from the Innovation Assistance Fund (FSI) in the amount of 5 million rubles. In December 2020, the company approved a FSI grant of 10 million rubles, which is planned to be used to increase production capacities for production.

According to the director of Histograft Ilya Bozo, the global market for osteoplastic materials is $2.68 billion, and in Russia - 1.5 billion rubles. Moreover, according to Bozo, the Russian market has great growth potential. More than 100 types of products for various versions of bone plastic are presented on the market, but only Histograph has the ability to stimulate bone tissue regeneration, he said.

2017

Obtaining the status of Skolkovo resident

In July 2017, the Histograft Research Company received the status of resident of the Skolkovo Foundation in a cluster of biomedical technologies with the project "Development and implementation of a technological platform of gene-activated materials for regenerative medicine." It was for the implementation of this project that the company was founded in 2015.

Registration clinical trials of the first Histograph product

In March 2017, the company announced the start of registration clinical trials of its first product, a gene-activated material for bone plastics, which proved safety and effectiveness in preclinical studies.

The material named after the company - Histograft (the old name used in the technical documentation - Nucleostim-VEGF) is octacalcium phosphate granules "activated" plasmid DNA with a gene encoding vascular endothelial growth factor (VEGF). The biologically active component of the product is the active substance of the drug "Neovasculgen," developed by the Human Stem Cell Institute, and the method of producing octacalcium phosphate is a scientific team from the A.A. Baykov Institute of Metallurgy and Materials Science of the Russian Academy of Sciences under the leadership of a member-corr. RAS, Ph.D., V.S. Komleva.

The Histograft product has a pronounced osteoinductive effect and leads to accelerated formation of bone tissue even outside direct contact with the walls of the bone defect, which was revealed in experimental studies in vivo. The reason for this effect was the action of plasmid DNA carrying the VEGF gene: biologically active nucleic acids stimulated therapeutic angiogenesis (vascular growth), critically important for bone tissue repair. Carrier matrices without biologically active nucleic acids do not have such osteoinductive action.