Ningxia Medical University to License Innovative Bilayer Guided Tissue Regeneration Membrane for RMB 5,000

Recently, Ningxia Medical University released a public notice on the conversion of scientific and technological achievements, proposing to transfer its“A Bilayer Functional Guided Tissue Regeneration Membrane Loaded with Dual-Component Drugs and Its Preparation Method”The patent is licensed to the industry partner through negotiated pricing, with the licensing fee beingRMB 5,000。

This patent is held by Ningxia Medical UniversityZhang Hualindeveloped, involvingGuided Tissue Regeneration Membrane (GTR Membrane), is a novel biomedical material that combines barrier protection, antibacterial and anti-inflammatory properties, and guided tissue regeneration functions, utilizingSolvent Casting and Emulsion Electrospinning TechniquesFabricated through composite preparation, the overall structure presents a bilayer differentiated architecture, with the outer layer beingPolyhydroxybutyrate Cast Films with Micron-Groove Topographical Structures, the inner layer isCore-Shell Structured Polyhydroxybutyrate Fiber Membranes Loaded with Ornidazole and Basic Fibroblast Growth Factor (bFGF), leveraging its excellent biocompatibility, biodegradability, and synergistic multifunctional advantages, it can be widely applied in the clinical treatment of diseases such as periodontitis and periodontal defects, providing a novel solution for periodontal tissue regeneration.

As a highly prevalent condition in the field of dentistry, periodontal disease has long been a focal point and challenge in clinical research. Guided tissue regeneration (GTR) membranes, as the core material for periodontal tissue regeneration therapy, directly determine therapeutic outcomes through their performance characteristics. The development and translation of this patented technology precisely target multiple market pain points within the industry, offering tailored solutions to overcome clinical treatment dilemmas.

The incidence of periodontal disease in China remains high, whileRegenerative Repair of Periodontal Supporting Tissues, which is the key to achieving a radical cure for periodontal disease. Conventional treatments for periodontal disease, such as subgingival scaling and root planing (SRP) and bone grafting, can eliminate periodontal pathogens and alleviate inflammatory symptoms. However, they only partially restore periodontal tissue structure and fail to achieve complete regeneration of supporting tissues, including the periodontal ligament and alveolar bone. Furthermore, residual periodontal pockets often persist postoperatively, leading to disease recurrence.

Meanwhile, guided tissue regeneration (GTR) membranes currently used in clinical practice still suffer from numerous limitations, failing to meet the diverse needs of clinical treatment: Most membrane materials feature a single-layer structure with limited functionality, providing only basic barrier isolation without simultaneously addressing antibacterial and pro-regenerative requirements; some drug-loaded membranes can carry only a single agent, either inhibiting pathogenic bacteria without supporting tissue regeneration, or promoting tissue regeneration without preventing postoperative infection. Furthermore, the drug release rate is difficult to control precisely, resulting in either transient antibacterial efficacy or rapid drug release that causes excessively high concentrations and subsequent side effects.

Furthermore, the substrate materials used in some membrane products exhibit poor biocompatibility, easily triggering host rejection responses. Their complex manufacturing processes and high production costs also hinder large-scale clinical adoption and widespread use. These persistent challenges have long constrained improvements in the therapeutic outcomes of periodontal disease, while simultaneously driving an urgent industry demand for novel multifunctional guided tissue regeneration membranes, thereby laying a solid foundation for the market translation of this patented technology.

Compared with existing guided tissue regeneration membrane technologies, this patent, by virtue of its breakthrough innovations in structural design, drug loading, and manufacturing processes, has established“Barrier Protection + Dual-Drug Synergy + Gentle Preparation”integrated solution, with prominent core innovations and distinct technical advantages, which can be summarized in three main aspects:

1. Dual-layer differentiated composite structure design, enabling precise functional zoning and synergistic enhancement。Unlike the limited single-functionality of traditional single-layer membrane materials, this patent innovatively adoptsOuter Casting FilmandInner Fibrous Membranecomposite structure, the outer layer of cast polyhydroxybutyrate membrane features a micro-grooved topological structure that effectively serves as a barrier to prevent gingival epithelial cells and connective tissue from invading the periodontal defect site, thereby providing a favorable growth environment for the adhesion, proliferation, and differentiation of periodontal ligament cells; the inner fibrous membrane is dedicated to drug loading and sustained release. Through structurally differentiated design, this system achieves precise synergy between “barrier protection” and “pharmacological therapy,” addressing the core limitation of traditional membranes with single functionality.

Second, precise dual-drug loading and innovative core-shell structure address both antibacterial and pro-regenerative requirements.This patent innovatively adoptsCore-Shell StructureBy employing emulsion electrospinning technology, ornidazole (a potent antibacterial agent) was loaded into the fiber shell layer, while basic fibroblast growth factor (bFGF, a core factor promoting tissue regeneration) was encapsulated within the fiber core layer. This design achieved segregated loading and precise, controllable release of both agents, enabling efficient inhibition of periodontal pathogens by ornidazole to reduce postoperative infection risk, while simultaneously sustaining bFGF-mediated regeneration and repair of periodontal supporting tissues (periodontal ligament and alveolar bone). This approach effectively addresses the limited therapeutic efficacy associated with single-drug-loaded membrane materials.

Third, a mild and efficient composite fabrication process that balances practicality, biocompatibility, and industrialization potential.This patent adoptsPreparation of Outer Layer Membrane via Solvent Casting and Emulsion ElectrospinningPreparation of the Inner Membrane, and then tightly bonding the two layers of membrane materials through a composite process. The preparation process is simple, with mild reaction conditions that do not require harsh environments such as high temperature and high pressure, effectively preserving drug activity and the biocompatibility of the membrane materials. Meanwhile, the substrate material, polyhydroxybutyrate (PHB), exhibits excellent biodegradability, allowing it to gradually degrade in vivo without the need for secondary surgical removal, thereby reducing patient suffering. Furthermore, the production cost is controllable, and the manufacturing process is mature and stable, providing strong support for subsequent large-scale production and clinical promotion.

Currently, the global market for guided tissue regeneration (GTR) membranes is developing steadily, with a rich variety of marketed products and projects under development. Based on market research, related products can be categorized into three types:

The first category comprises commercially available basic guided tissue regeneration membranes,As a category widely used in current clinical practice, it is mainly divided intoNon-absorbable membrane(Represented by polytetrafluoroethylene membranes）andAbsorbable membranes (mainly collagen membranes and polylactic acid membranes), with typical products including the US-made Geistlich Bio-Gide® collagen membrane and China-made Zhenghai Biomedical’s oral repair membrane. These products primarily function as barrier isolators and are predominantly fabricated from materials with favorable biocompatibility. Notably, the Geistlich Bio-Gide® collagen membrane and Zhenghai Biomedical’s oral repair membrane have gained widespread recognition in clinical applications due to their superior properties.

The second category is marketed single-drug-loaded guided tissue regeneration membranes,Single-drug loading (antibacterial or pro-regenerative) is incorporated onto a base membrane material. A typical example is the drug-loaded electrospun guided tissue regeneration membrane, which uses natural halloysite nanotubes (HNTs) as drug carriers to load the antibacterial agent polymyxin B (PMB), with gelatin and poly(racemic lactide-co-caprolactone) (P(DLLA-co-CL)) serving as the matrix materials. The composite nanofibrous membrane is fabricated via electrospinning technology. This approach not only leverages HNTs to mitigate the burst release of drugs but also enhances biocompatibility through the biomimetic structure of electrospun fibers, currently demonstrating application potential in periodontal and bone tissue repair scenarios.

The third category is multifunctional guided tissue regeneration membranes under development,Multiple research institutions and enterprises, both domestically and internationally, are focusing on this field, with primary R&D directions centered on composite structure design and multi-drug loading. Some universities and companies have already launched related products under development. These products aim to integrate multiple functions and explore more comprehensive therapeutic solutions. Currently, most are in the laboratory R&D or early stages of clinical trials, with the potential to enrich the product portfolio and drive industry upgrades in the future.