News Digest 08.11.2024 — 15.11.2024
Regulators
The strategy for the development of the rehabilitation industry is planned to be extended until 2030
Deputy Minister of Industry and Trade Ekaterina Priezzheva said at a working meeting in the Federation Council in early November that the department had prepared a draft Strategy for the Rehabilitation Industry until 2030. The document was developed in connection with the growing demand for relevant products.
According to the Ministry of Industry and Trade, in the first half of 2024, the growth in the production of technical rehabilitation equipment (TRE) amounted to 13 percent, a similar growth was recorded in 2023. Currently, according to Ekaterina Priezzheva, there are more than 270 enterprises in the rehabilitation industry in the country, most of the products are highly localized.
The Federation Council noted the export potential of the industry. Last year, sales of rehabilitation equipment abroad increased by 26 percent, in 2024 - by 16 percent. "The industry is knowledge-intensive and requires investment, which means support from the state," concluded Ivan Yevstifeyev, a member of the Federation Council Committee on Economic Policy.
The deputy minister did not disclose the specific parameters of the new strategy. But she noted that the Ministry of Industry and Trade has also prepared a draft Government Resolution, according to which, starting in 2025, companies will be assessed using a point system based on the share of localization of production in Russia. The higher the score, the more preferences the enterprise will be able to receive.
Source: https://t.me/MedTechIndustry/1385
Market news
Sechenov University to create an engineering center for the development of medical devices for 300 million rubles
Sechenov University won the grant competition of the Ministry of Industry and Trade of the Russian Federation for projects to create and (or) develop engineering development centers. The university will use the grant in the amount of 300 million rubles to create an engineering center where medical devices will be developed. Additionally, the university will attract 150 million rubles from extra-budgetary funds for these purposes. It is planned that the facility will be commissioned in 2026.
The engineering center will be located in the Biomedical Science and Technology Park of Sechenov University. It is planned to develop polymer-based medical products, including personalized implants for maxillofacial surgery. In addition, the center's employees will form design documentation for implants used in this area and pediatric neurosurgery.
The center's products will be used in minimally invasive surgery in urology, in the treatment of the gastrointestinal tract, as well as in abdominal surgery. Other possible areas of application for the products include obstetrics and gynecology, otolaryngology, IVF, prosthetics, angioplasty, and blood service. The samples will be validated in the clinics of Sechenov University and other medical institutions, and then distributed to clinics throughout the country. The specialists will develop the products together with industrial partners, including Rosatom and Rostec, said Alexander Kulish, Director of Commercialization of the University.
Tomsk State University was also included in the list of winners of the grant competition of the Ministry of Industry and Trade - the institution will be allocated 300 million rubles to create a center for engineering developments in the field of chemical technologies and devices. Among other things, the developments will be used in the pharmaceutical industry. The university will attract another 170 million rubles from extra-budgetary funds to implement the project.
In July 2024, the Foundation for Assistance to Innovations approved 2 thousand projects - winners of the Student Startup competition 2024, each of which is provided a grant of 1 million rubles. More than 150 initiatives from the total number relate to medicine, pharmaceuticals and health protection. Sechenov University was among the laureates. Other winners are in the Vademecum review.
Khabarovsk Krai will receive 141 million rubles for the purchase of medical equipment for the oncology center
The Government of the Russian Federation approved the redistribution of funds for regional budgets to equip medical organizations with equipment for the treatment of patients with cancer. Thus, by the end of 2024, an additional 141 million rubles will be allocated to Khabarovsk Krai to equip the Regional Clinical Oncology Center with endoscopic equipment. Previously, 50.7 million rubles were allocated for these purposes for the subject.
Additional funding will be allocated under the federal project "Fight against cancer". Changes have been made to the distribution of subsidies to regional budgets, in accordance with the Federal Law "On the Federal Budget for 2024 and for the Planning Period of 2025 and 2026" in terms of financing the re-equipment of medical organizations providing assistance to cancer patients. Thus, the Chelyabinsk Region, according to the adopted document, will receive 30.7 million rubles less. Also, a reduction in subsidies is envisaged for the Republic of Dagestan (by 29.1 million rubles), the Bryansk Region (by 22 million rubles), Sevastopol (by 20 million rubles), Perm Krai (by 18 million rubles), the Irkutsk Region (by 15 million rubles), the Udmurt Republic (by 1 3.6 million rubles) and the Moscow Region (by 11.7 million rubles). In addition, changes were made to the funding of 51 more regions.
The government order also made adjustments to the funding provided for equipping regional vascular centers and primary vascular departments for 2024. The subsidy for these purposes will be reduced by almost 100 million rubles for the Moscow Region. The reduction in funding will also affect the Chelyabinsk Region (by 42 million rubles), Belgorod Region (by 37.1 million rubles), Tomsk Region (by 32.8 million rubles), Udmurt Republic (by 23.8 million rubles), Oryol Region (by 23.5 million rubles), Novosibirsk Region (by 23.1 million rubles) and the Republic of Crimea (by 21.4 million rubles). The changes will affect 44 more regions.
In November 2024, at a plenary session of the Federation Council, Russian Health Minister Mikhail Murashko first disclosed detailed financial characteristics of the national project "Long and Active Life" for 2025-2030. It will include 11 federal projects, including "Fight against Cancer", which will cost 885.1 billion rubles, or about 147 billion per year. In total, they intend to allocate 2 trillion rubles to finance the national project.
Roscosmos structure expanded production of knee microprocessor modules for 500 million rubles
The Precision Instrument-Making System (NPK SPP), a subsidiary of Roscosmos, expanded serial production of knee microprocessor modules by 30%. Investments in the project amounted to more than 500 million rubles.
The funds were used for development, launch of serial production and expansion of the knee module series. The module localization is at the level of 95.6%. Director of the Nizhny Novgorod branch of NPK SPP Anton Babaev clarified that in 2024, the retail cost of the device for the consumer is about 1.5 million rubles.
Babayev stated that at the moment the Russian market demand for microprocessor-controlled knee modules is from 1 to 3 thousand units per year, based on a number of factors: demographics, level of disability and economic conditions. The company representative noted that the expansion of capacities is necessary to meet the growing demand and ensure stable supplies, but the exact number of devices per year will be produced is not reported.
The Aktiv-2 knee module is manufactured at the company's site in Veliky Novgorod. In addition to the main operating modes (walking, light running), the module has a number of other functions: modes of assistance when getting up, stumbling, moving up the stairs, and a cycling mode. The module is intended for patients with amputation above the knee joint, including disarticulation in the knee and hip joint.
NPK SPP emphasized that at least five Russian organizations are currently working on the creation of knee modules with microprocessor control. Thus, MPO Metallist (a subsidiary of Rostec) produces such a module in a series of 200 pieces. They plan to launch serial production in early 2025, and then expand it to 500 units. The market value of one module is from 1.5 million rubles.
Steplife also announced the launch of serial production of 100 modules in 2025. Within three years, production volume will be increased to 500 units. One knee module with microprocessor control from Steplife costs 1.95 million rubles - this, according to the company, is 30-40% cheaper than Western analogues.
According to SPARK-Interfax, JSC NPK SPP was registered in Moscow in 1994. The main activity of the company is scientific research and development in the field of natural and technical sciences. There is no information on revenue and profit for 2023. The company has been on the US sanctions list since July 2023. In November 2024, it became known that the closed-end mutual investment fund Pervaya - Direct Investments, managed by UK Pervaya (part of the Sber ecosystem), became a co-owner of a 10.16% stake in MK Homo Auktus, which 100% consolidated the main production asset of Motorika. The company is a developer of products using artificial intelligence technologies, and since 2015 has been creating and producing functional hand prostheses with an individual design.
Other
America to create intergovernmental laboratory for testing artificial intelligence in healthcare
A laboratory under the supervision of the Food and Drug Administration (FDA) and the Department of Veterans Affairs will be engaged in testing programs and medical products based on artificial intelligence.
As reported by the media, the main purpose of creating the new structure is to test services based on artificial intelligence (AI) for compliance with the declared capabilities. Lab experts The speakers will also study the market potential and scalability of solutions, identify their potential problems and address safety issues.
Source: https://t.me/medicalksu/5337
Newly registered medical devices
We publish a list of new medical devices registered from 11.08.2024 to 11.15.2024
Link to the list: [see table in the attachment]
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