Project Introduction

As the population ages, osteoporotic fractures have become a challenging issue for scientists and clinicians. Bone cement is the primary material used in the treatment of osteoporotic fractures, and the current market is dominated by brands from Europe and the United States. Our team has developed PSC bone cement, which has overcome the limitations of existing products in terms of performance, comprehensively outperforming the current market offerings, and boasts strong competitive advantages.

The core material of PSC bone cement is the proprietary PSC bioactive glass developed by our team, which offers unparalleled benefits such as enhanced bone formation, promotion of endothelial cell proliferation and angiogenesis, higher biological activity, controlled degradation rate, stable physiological pH after implantation, and a cost reduction of approximately 50%. It has unparalleled advantages over metal, polymer materials, biologically inert materials, and existing bioactive glasses. It is the only bioactive material in the world that can simultaneously repair and bond both hard and soft tissues. In summary, PSC bone cement addresses the challenges faced by existing bone cements in the treatment of osteoporotic fractures.

Its key advantages include:

Enhanced biological activity, promoting bone repair and avoiding mechanical support failure due to delayed bone regeneration caused by material degradation.

The mineralization process under bodily fluids produces hydroxyapatite, contributing to the continuous enhancement of mechanical properties.

Neutral pH facilitates compatibility with other excipients, allowing for a wider range of component adjustments, which is conducive to the development of formulations with varying injection and mechanical properties for use in multiple indications.

This project aims to address the shortcomings and pain points in current clinical practice by developing new clinical products, belonging to high-end implantable medical devices that will effectively improve patients' quality of life, promote social development, and achieve China's upgrading and transformation in the medical device industry chain.

Project Significance

Osteoporotic fractures often require surgical treatment. The current challenges are: fractures are mostly comminuted, combined with poor bone quality, leading to a high failure rate of fixation and reduction of up to 41%. This makes it difficult for both patients and doctors to be satisfied with the final outcome. Therefore, injectable bone substitutes (commonly known as bone cement) are generally required for intervention. Currently, there are two types of bone cements commonly used: one is non-absorbable bone cement, such as polymethyl methacrylate (PMMA); the other is absorbable bone cement, such as calcium phosphate cement (CSPC). Both types of bone cements have severe drawbacks in clinical applications. Currently, the PSC bone cement formula has been produced for over 500 cases, undergoing physical and chemical properties, biological performance, and animal experiments. The experimental results demonstrate a high degree of consistency, confirming the stability of the production process. Animal experiments show that compared to the clinically most commonly used PMMA and CPC bone cements, PSC bone cement exhibits the best osteogenic effect, providing sufficient mechanical support and excellent osteogenic activity during bone healing, aiding in the repair of defective areas. After PSC bone cement filling, the speed of bone repair is completely consistent with the degradation rate of the cement, with the cement itself being absorbed completely within approximately 6 months, ensuring sufficient mechanical support in the defect area for an extended period and avoiding the possibility of secondary fractures. Moreover, PSC bone cement does not disintegrate after injection, reducing the risk of pulmonary embolism and providing long-term mechanical support to meet the needs of bone repair. This product has been finalized, with the production process also finalized, and is ready for industrialization.

The potential market

As per EU statistics in 2013, recorded approximately 3.5 million new cases of osteoporotic fractures annually, resulting in medical expenses of roughly 37 billion euros. In contrast, the National Bureau of Statistics of China estimated in 2010 that there were over 80 million osteoporosis patients in China. Based on current consumption patterns, the market space for just osteoporotic fractures in China is estimated to be around 15 billion yuan, with an annual growth rate exceeding 10%. Leveraging its superior operational performance and efficacy, our product is poised to gradually penetrate the orthopedic trauma and dental filling material markets, further expanding its market potential. As global aging accelerates and economic levels rise, and given China's current internationalization trend, we conservatively project that we will enter a market exceeding 100 billion yuan with continuous growth.