Vadim Stepanov, Director of Tomsk NRMC, Academician of the Russian Academy of Sciences:— Modern medicine is an interdisciplinary, complex field where progress is impossible without consolidated effort. Together with the universities within Big University of Tomsk, and with our colleagues from scientific and medical organizations across Russia, we are working to create new technologies that position us as leaders in knowledge generation — not only nationally, but on the global stage. These are critical technologies for personalized medicine and the health of the nation, benefiting thousands of patients who will receive high-tech, quality medical care.
Scientists at the Cancer Research Institute, Tomsk NRMC, in collaboration with colleagues from Tomsk Polytechnic University (TPU), have created unique fluoropolymer implants for patients with maxillofacial tumors. Details on this development and its prospects are featured in the first article of the "Technologies for Life" series.
From Idea to Implementation in Two Years
Denis Kulbakin, Doctor of Medical Sciences, Head of the Head & Neck Cancer Unit, Cancer Research Institute, Tomsk NRMC:
— The need for specialized lightweight implants in maxillofacial surgery has long been evident. We joined forces with the TPU team and decided to use an innovative modern material — fluoropolymers — for our new devices. Fluoropolymer products outperform many alternatives due to their unique properties. Their lightness, strength, and biocompatibility make them ideally suited for maxillofacial surgery.
We have been developing these implants for approximately three years. The first two years were dedicated to selecting the optimal shape, design, thickness, and conducting laboratory research. Once we confirmed the strength and safety of the fluoropolymer constructs, we began using the first models in clinical practice.
In 2024, we refined both the shape and manufacturing method. The core concept remained the same, but we improved the structure, design, and fixation technique. These enhancements have increased the implant's integration with the body's own tissues.
A major drawback of metal implants is their radiopacity. They absorb X-rays and can obscure areas where tumor recurrence might occur. Fluoropolymers allow for complete visualization of the maxillary region due to the absence of "metal artifact."
High-quality implants help minimize risks during tissue recovery. Fluoropolymer materials not only reduce long-term procedural trauma but also improve both the appearance and functionality of reconstructed areas. Each implant is custom-designed to match the facial contours and individual needs of every patient, ensuring high-quality outcomes and minimal recovery times.
Service Life
— Fluoropolymer implants have no strictly defined expiration date. In most cases, they can serve patients for many years, though occasionally complications such as inflammation or extrusion may arise, requiring surgical intervention. In such instances, we use the patient's own tissues to close the defect whenever possible.
Based on our data and global studies, fluoropolymer devices can function reliably for decades, though this ultimately depends on individual patient characteristics.
Manufacturing Process
The raw materials for the implants are produced within the Russian Federation by GaloPolymer, ensuring our independence from external factors.
- JSC GaloPolymer is one of the world's largest fluoropolymer producers, accounting for 10% of the global market.
The manufacturing process involves several stages: we take the finished raw material, purify it to the required specifications, convert it into filament, load it into the printer, and print.
- Filament is a plastic thread designed for 3D printers.
Alexander Vorobyov, Engineer, Research School of Chemical & Applied Biomedical Sciences, TPU:
— Creating a single implant takes no more than one week. At each stage, we discuss details with physicians and surgeons, selecting the optimal shape and porosity based on the patient's individual anatomy. After printing, we sterilize the finished product and deliver it to the Cancer Research Institute for clinical use.
What is the manufacturing cost?
— Currently, this work is supported by the federal Priority-2030 program. But providing a specific figure is difficult. The price depends on configuration, size, anatomical site, and other factors. However, manufacturing a fluoropolymer implant is typically about 30% cheaper than producing a metal one.
Potential and Prospects
Denis Kulbakin, Doctor of Medical Sciences, Head of the Head & Neck Cancer Unit, Cancer Research Institute, Tomsk NRMC:
— We will continue refining the technology. Techniques like prefabrication and lamination exist, where the implant is placed under the patient's skin away from the maxillofacial area and later retrieved along with surrounding tissue. This approach creates a composite of the implant and the patient's own tissues. We have already attempted this with several successful cases. With each operation, we gradually improve the design, thickness, and strength of the devices.
The implants produced in Tomsk surpass foreign analogues in several respects. Our material is denser, with properties closer to metals. Additionally, we have achieved controlled porosity. This porosity allows tissue (such as bone) to grow into the implant structure, which is crucial for successful integration.
Evgeny Bolbasov, Candidate of Technical Sciences, Research Scientist, Weinberg Research Center (School of Nuclear Science and Engineering), TPU:
— Oncologic surgery is a powerful locomotive driving innovation across other medical fields. New diagnostic methods like CT and MRI first emerged in oncology before spreading to other disciplines.
Our development certainly has potential for widespread use. The technology is still new, so launching large-scale production requires a more extensive database and long-term follow-up to observe implant performance over time.
Today, we are prepared to meet 100% of market demand. However, the scaling challenge lies in the fact that a new material means a new surgical technique. We cannot simply approach, say, a Moscow clinic handling similar cases and say, "Here are our implants, please use them." Surgeons need specific training to perform these procedures; they would need to come to us and learn. Before fluoropolymers can firmly establish their niche in oncologic surgery, a new generation of specialists proficient in these technologies must emerge. A regulatory framework is also needed to enable widespread adoption of our implants.
The Clinic at the Cancer Research Institute, Tomsk NRMC, is ready to accept oncology patients with maxillofacial tumors (oral cavity, upper and lower jaw), as well as those with postoperative maxillofacial defects following prior surgical treatment. For each case, our specialists develop a detailed treatment plan.
Important: Treatment for patients with active tumor processes is provided at the clinics of the Cancer Research Institute, Tomsk NRMC, free of charge under the high-tech medical care program or compulsory medical insurance.