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HSCI Invested in Histograft Company

Human Stem Cell Institute (HSCI) signed an investment agreement with Histograft LLC, a Russian biotech company, Skolkovo resident. The company is a pioneer in the development and deployment of first-in-class gene-activated materials for medical applications.

The total investment in the project amounted to RUB 37.7 million. 22.765 million roubles in two rounds were invested in Histograft LLC by entrepreneur Artur Isaev, Chairman of HSCI’s Board of Directors, and 15 million roubles – by HSCI.

Gene-activated matrices represent an innovation, developed and introduced into clinical practice for the first time in the world by HSCI and the Histograft team. HSCI owns a number of patents protecting intellectual property and has a license agreement with Histograft signed. In addition, by now Histograft company has formed its own patent portfolio that protects the rights to use this novel technology in the world.

Previously, Histograft received support from the Innovation Promotion Fund (IPF) under the START-1 and START-2 programmes, with a total amount of RUB 5 million. On December 11, 2020, the IPF approved the grant in the amount of RUB 10 million for Histograft under the Business Start programme. The money will be used to increase the production capacity. In 2019, Histograft LLC received marketing authorization (No. RZN 2019/8310 of April 23, 2019) for the first product in a pipeline from the Russian healthcare regulator. In April 2020, the company began its production and introduction into clinical practice in Russia. The world’s first gene-activated bone substitute is intended for bone augmentation prior to the placement of dental implants and for the treatment of patients with bone defects.

According to Ilya Bozo, Director of Histograft LLC: “The global market for osteoplastic materials is estimated at USD 2.68 billion annually. In Russia, it is about RUB 1.5 billion, with significant growth potential. There are more than 100 items on the market for various types of bone grafting, but only “Histograft” gene-activated bone substitute has the ability to stimulate bone tissue regeneration.»

The gene-activated bone substitute, marketed as Histograft, is based on octacalcium phosphate (OCP) granules and naked plasmid DNA carrying the vascular endothelial growth factor gene (pDNA-VEGF). The granules serve as a matrix for bone formation, and the DNA increases blood supply and bone tissue regeneration in the surgical area. The novel material simplifies bone grafting by eliminating the need to use the patient’s own bone tissue, and brings the results of treatment to a qualitatively new level.

At present, Histograft LLC, in cooperation with HSCI and the Institute of Metallurgy and Materials Science of the Russian Academy of Sciences, continues to develop innovative gene-activated matrices containing plasmid DNA encoding therapeutic genes (VEGF, etc.) and plans to introduce into clinical practice the products as gel, membrane and personalized (3D-printed) implants. Prototypes have been developed, preclinical studies are being carried out, the 3D printing technology is undergoing an optimization stage based on the results of experimental studies on large laboratory animals.
“The creation of gene-activated materials is one of the key elements of the Healthnet Roadmap of the National Technology Initiative,” says Sergey Masyuk, General Director of HSCI. The roadmap was approved by the decision of the Presidium of the Council under the President of the Russian Federation for economic modernization and innovative development of Russia and was created to ensure leadership in the global healthcare market.”