News Digest 10.04.2024 — 12.04.2024
Regulators
The Ministry of Industry and Trade commented on the situation with dialysis solutions in Russia
The Ministry of Industry and Trade reported on measures being taken to expand the range of dosages of peritoneal dialysis solutions required for the Russian market. As the ministry’s press service told FV, the drug “Diasolution PD” has already been registered this year, and “Diasolution” was also registered earlier.
The Ministry of Industry and Trade also stated that in the future it is planned to meet the needs of the Russian healthcare system in this area.
Nowadays, patients with kidney diseases have access to different types of dialysis - peritoneal dialysis, hemodialysis, acute dialysis.
“Due to the current anti-Russian sanctions, logistics restrictions also arise. Therefore, the start of production of domestic solutions for peritoneal dialysis is an important step in ensuring the drug safety of Russian patients in this direction,” the Ministry of Industry and Trade said.
Earlier it became known that the American supplier of dialysis solutions Baxter International suspended its activities in Russia. The company explained its move by sanctions and logistics problems.
Market news
Artgen invested another 40 million rubles in the development of medical products for tissue engineering
The biotechnology company Artgen (formerly the Human Stem Cell Institute, HSCI) has entered into a new investment agreement with the portfolio company Histograft, a Skolkovo resident specializing in the development and implementation of gene-activated materials for regenerative medicine. The company invested another 40 million rubles in the development of five medical devices for tissue engineering. The total investment of Artgen in the project increased to 90 million rubles, and the ownership share in Gistograft increased to 64%.
The funds received will be used to complete preclinical studies of the products being developed, as well as to expand the indications for the use of the first product for bone tissue regeneration.
The first development, “Histograft,” is used for bone grafting as an osteoinductive material and is actively used in dentistry to treat patients with bone damage. The developer’s website states that the drug ensures accelerated formation of blood vessels in the surgical area due to plasmid DNA with the VEGF gene - this simplifies and qualitatively improves bone tissue regeneration, minimizing the use of the patient’s own bone tissue.
“Histograft” was registered in 2019, and production and introduction of the drug into clinical practice began in April 2020. Over four years, the drug was used to treat more than 3.5 thousand patients.
In January 2021, HSCI invested 37.7 million rubles in Histograft. The procedure for attracting investments took place in two rounds - 22.7 million rubles were invested by the founder and chairman of the board of directors of HSCI Artur Isaev, another 15 million were invested by HSCI itself. Between 2022 and 2023, HSCI invested another 50 million rubles and acquired a controlling stake in the company. In 2023, HSCI changed its name to “Artgen”.
According to SPARK-Interfax, as of the end of December 2023, a share of 57.73% of Gistograft LLC is owned by PJSC Artgen, 16.9% belongs to the founder of the holding Artur Isaev, another 16.4% is owned by Roman Deev, and 8 .95% belong to Ilya Bozo. In 2023, the company gained 5.9 million rubles, the loss amounted to 16.3 million rubles.
Investments in the construction of a medical center in Perm increased from 80 to 320 million rubles
The Council for Entrepreneurship and Improving the Investment Climate of the Perm Region decided to increase financial investments in the construction of a diagnostic and treatment center in Perm from the previously announced 80 million rubles to 320 million rubles. The construction of the medical center is planned to be completed by 2026.
A proposal to increase financing in March 2024 was made by the project investor, EXO Property LLC. In addition, the company planned to increase the clinic area from 1.5 thousand to 4 thousand square meters. m and the number of floors from two to five.
At first, it was planned to open a center for the study and treatment of the brain in the building. "EXO Property" received the status of a priority investment project, which later helped to obtain a land plot without bidding.
However, at the final stage, it was determined that several medical organizations would be located on the site, which would provide dental services, profile for ENT diseases and carry out scalp restoration procedures.
According to SPARK-Interfax, EXO Property LLC was registered in Perm in 2006. The main activity of the company is the management of real estate on a fee or contract basis. 33.33% each belong to Maxim Trubnikov, Daniil Morozov, and Denis Konogorov. The company's revenue in 2023 amounted to 3.2 million rubles.
In Voronezh, production of Foley catheters will be launched for 285 million rubles
Governor of the Voronezh region Alexander Gusev, at a meeting with the founders of the Caspis BioTech company on April 9, approved a project to create a plant for the production of medical Foley catheters in the special economic zone (SEZ) “Center”. Investments in the project were estimated at 285 million rubles. The company clarified that full-cycle production will be the first in Russia and will allow the production of 5 million catheters per year.
Caspis BioTech CEO Dmitry Perutsky said that the organization is about to merge with a partner company, which has been producing and selling catheters in Russia for eight years; its products account for about 25% of the market in the country. Perutsky did not provide information about the partner, noting that they already have a regulatory certificate for a medical product. The catheters are currently being produced at a site in China.
Caspis BioTech plans to purchase latex from foreign partners once a year in the amount of about 80 tons - this is enough for an annual production cycle. The company indicated that domestic companies that produce latex gloves already have similar experience.
A land plot of 1 hectare has been identified for the location of the plant. It is planned to create 33 jobs. According to the investor, the average salary of employees will be about 59 thousand rubles.
“It will have to be higher, because many people on the site have higher salaries. Finding people will simply be difficult. Yes, the average salary in the industry is about 60 thousand, but now the demand for personnel is high. Here you don’t even have to focus on numbers – you just look at your neighbors and understand how much money people come to work for,” noted Alexander Gusev.
According to SPARK-Interfax, Caspis BioTech LLC was registered in Belgorod in 2022. The company produces medical instruments and equipment. In January 2024, the organization decided to change its location to the Voronezh region. The company is owned in equal shares (33.34%) by Sergey Lokinsky, Dmitry Perutsky and Sergey Chuzhinov. There is no data on revenue in 2023, the loss amounted to 208 thousand rubles.
SEZ "Center" was created in December 2018. The area to accommodate residents is 168 hectares and can accommodate up to 20 enterprises. On the northern side, the SEZ is adjacent to the Maslovsky industrial park.
In January 2024, deputies of the Voronezh city parliament discussed with potential investors the construction of a pharmaceutical plant on the territory of Maslovka. Investments in the project are estimated at 10 billion rubles, but the name of the possible implementer of the project has not yet been disclosed. They want to export the products produced at the enterprise. Every year the plant intends to produce about 90 million bottles of drugs, and it is also possible to produce tablet products.
More than 550 million rubles will be allocated for the purchase of ophthalmological equipment in the Moscow region
In 2024, 389 units of medical equipment for the diagnosis and treatment of vision will be purchased for the needs of medical organizations in the Moscow region. More than 550 million rubles will be allocated for these purposes. Medical equipment will go to 44 medical organizations in various municipalities of the region.
Medical equipment is purchased under the national Healthcare project. Orekhovo-Zuevskaya, Klinskaya, Protvinskaya, Shchelkovskaya, Mytishchi, Odintsovo and other hospitals will receive vision testing equipment.
Source: https://web.telegram.org/k/#@vademecum_live
Belgorod authorities will expand a children's health camp in Crimea for 119 million rubles
The Capital Construction Department of the Belgorod Region began searching for a contractor to carry out survey work and prepare a project for the construction of a children's health camp "Brigantina Belogorye" on the territory of a sanatorium in Yevpatoria (the region received a health resort from the Crimean authorities free of charge in June 2021). The initial price of the contract is 119.3 million rubles. They intend to finance it from the regional budget.
According to the terms of reference, the contractor must develop a project for the construction of four separate buildings with a height of no more than three floors. The number of places in the camp will be 530, it should operate year-round. One building will be able to accommodate 125 children; rooms with amenities are designed to accommodate three to four people each. The dining room has a capacity of 300 seats. It is also necessary to provide a medical unit with one doctor's office and one treatment room. The medical block includes a dental office, a medical-grade room with an area of at least 50 square meters. m, an office for correctional and developmental classes and other auxiliary premises.
It is also planned to build a physical education and health center, an interactive center with a complex of workshops, a hotel with 110 seats, an amphitheater with 800 seats and several checkpoints. The project must contain the distribution of areas for tourism and outdoor dining.
The contractor must complete the work by December 20, 2024, taking into account the positive conclusion of the state examination. They have a two-year warranty. Applications for participation in the competition are accepted until April 26, the contractor will be selected on May 6.
The Belgorod region received use of the sanatorium in June 2021. It is located in the urban village of Zaozernoye in Yevpatoria and covers an area of 14 hectares. It includes dormitories, a dining room, a gym, a cinema hall, a school, a medical building, a library and a swimming pool. The sanatorium is designed for 300 people per shift and is suitable for year-round operation.
In 2022, 2 billion rubles were allocated from the budget of the Belgorod region for the reconstruction of the facility. The governor of the region, Vyacheslav Gladkov, noted in July 2022 that during the overhaul it is planned to replace the roof, facades, window and door units, internal utility networks in the sanatorium buildings, decorate the premises and improve the territory. In 2023, the camp accepted its first children.
In January 2024, it became known that Sevproektmontazh LLC would, for 500 million rubles, install a fountain and a beach in the sanatorium, equip a swimming pool, carry out work on heating and sewerage networks, as well as electrical installation work.
Vyacheslav Gladkov said at the end of February 2024 that construction of the second stage of the children’s sanatorium would start in 2025. “We have a plan for the construction of the second stage, we reviewed and approved it at the town planning council, we are now engaged in design, then we will undergo state examination, and next year we will begin construction of the second stage,” Gladkov explained.
At the moment, 277 children can relax in the sanatorium during one shift. After the expansion, about 800 children per shift, or about 12 thousand per year, will be able to relax and improve their health there at the same time.
In Yevpatoria, the construction of the Federal Children's Rehabilitation Center with 300 beds is also ongoing. It was planned to allocate up to 15.47 billion rubles for the construction of the facility. But at the beginning of April 2024, the Government of the Russian Federation decided to change the cost of construction to 18.74 billion rubles. The contractor must put the facility into operation by December 31, 2026.
Other
A new approach to creating implants for bone tissue has been proposed in Russia
A new approach to creating affordable modern implants for maxillofacial surgery was developed by scientists from Tomsk Polytechnic University. According to the authors, the development will reduce the rehabilitation period for patients after surgery to restore bone defects. The results were published in the journal Materials Letters.
Restoring bone tissue defects requires a personalized approach: the implant must take into account the anatomical characteristics of each patient. At the Public Access Additive Technologies Center of Tomsk Polytechnic University, such implants are produced by 3D printing from domestically produced fluoroplastic polymer. This biologically inert material ensures the absence of allergies and other negative reactions of the body to the implant. At the same time, this polymer does not fuse well with bone tissue.
Scientists at Tomsk Polytechnic University set themselves the task of applying hydroxyapatite particles, a mineral component of bone, to the surface of fluoroplastic, which promotes the attachment and proliferation of bone tissue cells. In traumatology, orthopedics and surgery, synthetic hydroxyapatite is used as a filler to replace parts of lost tissue, and as a coating for implants to promote the growth of new bone. In dentistry, it is used in toothpastes to remineralize and strengthen tooth enamel.
The novelty of the method developed by Tomsk Polytechnic University scientists for applying hydroxyapatite particles to the surface of fluoroplastic implants is that it can be implemented using exclusively Russian materials and equipment in any chemical laboratory, said Semyon Goreninsky, a researcher at the Public Access Additive Technologies Center of Tomsk Polytechnic University.
Source: https://digital.gov.ru/ru/events/50222/
New registered medical devices
We publish a list of new medical devices registered from 04/05/2024 to 04/12/2024
Link to the list: [see. table in attachment]
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