| Developers: | Pozvonoq |
| Date of the premiere of the system: | Nov 2021 |
| Branches: | Pharmaceuticals, Medicine, Healthcare |
Content |
Main article: Implants for spondylodesis (global market)
2023: Product registration in Russia
Startup Pozvonoq (a joint venture of the North-West Nanocenter and Orthoinvest Group of Companies) has registered the first 3D-printer implants for the spine in Russia. This was reported on February 16, 2023 in the press service of the Foundation for Infrastructure and Educational Programs (FIOP).
Roszdravnadzor issued a registration certificate to 3D-Cage LLC for 10 lines of intervertebral cage intended for the treatment of the cervical and lumbosacral spine. These products are made from biocompatible titanium alloy by 3D printing.
Medical devices are used to treat herniated disc, degenerative-dystrophic changes in the spine, spinal tumors. Implants are created from a biocompatible titanium alloy taking into account the specifics of the defect and anatomical features of the patient's musculoskeletal system and have a high engraftment rate. Operations using individual Pozvonoq cages are carried out at the R.R. Wreden National Medical Research Center, Volga Research Medical University (PIMU) and other medical institutions.
As reported in the FIOP on February 16, 2023, about 40 thousand operations on the spine are carried out annually in Russia. A quarter of them are carried out using implants. Until recently, the Russian intervertebral cage market was formed mainly by offers from foreign manufacturers. According to experts, in the past two years there has been a trend towards a reduction in imports of vertebrate cages, since 2022 the downward trend has strengthened. According to the data of public procurement of implants and consumables for injuries and diseases of the spine, in 2022 the volume of the Russian market amounted to about 10 thousand cages, the fund added.[1]
2022
Completion of tests, start-up of full-scale production
At the end of September 2022, the Rusnano group announced the launch of serial production of Pozvonoq implants (the startup is a portfolio company of Rusnano) designed to treat spinal diseases, such as herniated disc, degenerative-dystrophic changes in the spine, as well as spinal tumors. The products have been successfully tested and can now be released to the mass market.
The intervertebral cages of startup Pozvonoq are designed to solve the problems of stabilizing the spinal column. The implants were developed by neurosurgeons of the R.R. Wreden National Medical Research Center and transferred to Pozvonoq for further refinement, testing and adaptation for mass production. The product will be produced from a biocompatible titanium alloy by 3D printing.
3D cages are used as an implant when replacing a damaged intervertebral disc by accessing the affected area through the abdominal cavity. This type of surgery requires special design features of the spinal implant: verified geometry of the shape, a well-thought-out attachment system, biocompatibility and strength of the material. All these characteristics were taken into account when creating the Fusion-F cage series.
One of the latest laboratory tests in the preclinical cycle was the study of the possible use of implants in a technical experiment in animals. Pigs were chosen as the biomodel. No signs of local and general inflammation or other implantation-related complications were detected during the entire animal observation period. Now the products have successfully passed a cycle of preclinical tests. The test results confirmed the high quality of the implants and good functional results in the postoperative period.[2]
Complete preclinical run
Intervertebral cages startup Pozvonoq used to solve the problems of stabilizing the spinal column have undergone a cycle of preclinical tests. The test results confirmed the quality of the products and the functional results in the postoperative period. This was announced on September 26, 2022 by the North-West Technology Transfer Center (SZCTT).
As reported, one of the latest laboratory tests in the preclinical cycle was the study of the possible use of implants in a technical experiment in animals. Pigs were chosen as the biomodel. The tests were conducted by the "Center for Preclinical Research" as part of a group of medical and veterinary specialists with experience in experimental surgery and traumatology.
No signs of local and general inflammation, as well as other implantation-related complications requiring repeated interventions or premature termination of experimental follow-up, were detected during the entire animal observation period. Further histological examination established active bone formation in areas of implants with tight fixation of cage in animal tissue.
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 | According to the results of the study, there were no signs of rejection of products and other characteristics of biological incompatibility. Now we can move on to the final stage - clinical trials by cage. commented Olga Voblaya, head of startup Pozvonoq |  |
Carrying out a cycle of laboratory studies and test operations is a necessary stage for certification of medical devices. After receiving the registration certificate of Roszdravnadzor, the startup will launch mass production of Pozvonoq implants. The appearance of intervertebral cages in the healthcare market of the Russian Federation will allow replacing about 50 percent of implants for foreign-made spinal surgery.
2021: Start production of spinal surgery implants
Start-up of the Rusnano Group Infrastructure and Educational Programs Fund Pozvonoq has become a manufacturer of implants for spinal surgery developed by specialists of the R.R. Vreden National Medical Research Center for Traumatology and Orthopedics. Rusnano reported this on November 2, 2021.
The parties signed a licensing agreement, according to which the startup receives the right to produce and sell intervertebral cages of the Fusion-F series, developed and patented by specialists of the medical institution.
"Fusion-F" belongs to the category of intervertebral 3d-cages for anterior spondylodesis of the lumbar spine. The product is used as an implant when replacing a damaged intervertebral disc by accessing the affected area through the abdominal cavity. This type of surgery dictates special requirements for the design features of the spinal implant: verified geometry of the shape, a well-thought-out attachment system, biocompatibility and strength of the material. All these characteristics were taken into account when creating the Fusion-F cage series.
The concept of the product was developed by neurosurgeons of the National Medical Research Center TO named after R.R. Vreden and transferred to Pozvonoq for further refinement and adaptation for mass production.
| | The developed model of intervertebral cage is equipped with fixing elements. This feature allows you to install implants without additional attachment systems, ensuring high primary stability and the absence of migration in the postoperative period, "said Olga Voblaya, director of Pozvonoq startup. | |
The product will be produced from a biocompatible titanium alloy by 3D printing. The developed Fusion-F line includes 33 typical cage sizes. In addition to standard sizes, Pozvonoq will be able to produce individual implants based on the anatomical characteristics of the patient. The production period of the product will be 10-15 days from the date of order, and the average cost will be no more than 50,000 rubles. To sell the products, the Altermedica company will be involved - one of the representatives of distribution medical products in the traumatology and orthopedics market in Russia.
Notes
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