Fengxi Medical Files IPO Prospectus: Pioneering Smart Orthopedic and Dental Materials with Cold Sintering and Graphene Technologies

The wave of volume-based procurement for high-value medical consumables reached the orthopedics sector in 2020. Significant price reductions have ushered in new industry trends, with highly innovative and cost-effective products gaining a competitive edge. Orthopedic companies are increasingly focusing on upstream materials, striving to master complete production lines and secure autonomy in innovation and pricing.

However, the development of such materials is by no means an easy task. Due to their excellent biocompatibility, the demand for biomedical materials in fields such as joint replacement, dentistry, and cardiovascular applications continues to rise. Nevertheless, their research and development not only require the integration of multidisciplinary knowledge from materials science, medicine, and biology, but also depend on long-term practical accumulation. Currently, the majority of biomedical materials in China still rely on imports.

Over the course of a decade, Yu Xianzhu, founder of Fengxi Medical, has developed solid-solution cold sintering technology and graphene technology, primarily for the production of bone and dental materials. According to him, ceramics was once a niche field, with nearly all his classmates transitioning to other industries. However, his persistent dedication to this specialized area has now positioned him to benefit from the booming growth in upstream advanced materials.

In the medical field, cold sintering technology and graphene technology are the two pillars enabling Fengxi Medical to make significant strides forward.

Features such as low-temperature and rapid sintering give cold sintering technology numerous advantages in the field of ceramic sintering. Achieving densification of ceramics and alloy materials using traditional sintering methods typically requires high temperatures above 1,500°C, which poses significant operational challenges. In contrast, cold sintering technology can reduce the sintering temperature to 950°C, and even enable solidification at temperatures below 300°C, offering safer and more efficient operation.

Fengxi Medical’s independently developed solid-solution cold sintering technology, when combined with graphene, enables the machinability of tricalcium phosphate green bodies, significantly improving the mechanical properties and bioactivity of the sintered constructs without compromising the inherent biocompatibility and degradation performance of tricalcium phosphate.Because the solid solution process does not alter the structure of tricalcium phosphate, it resolves the brittleness issue that has long plagued its application.

Tricalcium phosphate bioceramic materials offer advantages such as excellent biocompatibility and corrosion resistance, with a composition similar to that of bone mineral. However, when used alone as a bone repair material, they exhibit drawbacks including high brittleness and poor toughness. Graphene, a ceramic-like material with a crystal structure analogous to diamond, features good biocompatibility, high adsorption capacity, and ease of surface modification. It is regarded in the medical field as a key driver of the next medical revolution.

While small quantities of graphene sheets can be obtained via chemical vapor deposition (CVD), large-scale extraction remains challenging, and materials produced through the oxidation-reduction method often contain impurities. Consequently, mass production has long been a major obstacle to the widespread application of graphene in the medical field.

After more than a decade of research and development, Fengxi Medical has developed a new technology for the low-cost, low-pollution mass production of graphene oxide and graphene based on smart material technology. This technology avoids the operational difficulties and environmental pollution associated with traditional concentrated sulfuric acid intercalation processes. By utilizing ordinary grain grinders, it enables the scalable manufacturing of graphene materials with high electrical conductivity, few surface defects, and excellent transparency, making them suitable for biomedical applications such as orthopedics.

These technologies are all integrated into Fengxi Medical’s orthopedic and dental materials, serving as the cornerstone of its core business operations.

Specifically,Solid-solution cold sintering technology endows tricalcium phosphate with intelligent properties, enabling the regulation of its osteogenic degradation rate. Furthermore, calcium phosphate solid-solution materials can sustainably release a mildly alkaline microenvironment after implantation in the human body, neutralizing the acidic environment caused by long-term tissue ischemia, and modulating bioactivity through magnesium ions.. Currently, bioactive artificial bone has become a focal point of R&D in the industry.

Meanwhile,Magnesium ions can also regulate the induced growth of vascular tissue, endowing the material with growth-promoting properties suitable for populations with growth needs, such as children. Sodium ions can modulate degradability by regulating the calcium-to-phosphorus ratio.Moreover, Fengxi Medical has developed an ultra-fine manufacturing technology that enables more precise integration of microvascular growth mechanisms within the material. As the material degrades and remodels after implantation, it facilitates the formation of a more optimal vascular network, thereby providing adequate cellular and nutrient supply for bone growth.

According to a prominent introduction, only one research institution in Japan has reported similar findings on tricalcium phosphate solid-solution materials worldwide.

Moreover,Fengxi Medical's Innovative Materials Feature Low Manufacturing Costs, ultra-cost-effective surgical instruments aligned with the national centralized procurement policy, such as orthopedic instruments, bone fixation devices, and artificial joints.

The company can provide safer orthopedic products for the elderly population. Since the bones of aging individuals lack regenerative capacity, safety is prioritized. Fengxi Medical’s materials encompass various ultra-high-safety medical-grade alloys and ceramics, engineered with biodegradable properties. Upon degradation, these materials facilitate the formation of new bone tissue, integrate securely with the human body, and resist loosening.

Leveraging intelligent material technology, Fengxi Medical’s innovative materials are suitable for 3D printing. Regarded in Germany as a key technology of the Fourth Industrial Revolution, 3D printing has attracted substantial investment from major corporations such as Johnson & Johnson, Siemens, and GE for its applications in the medical industry. Consequently, 3D printing has become a focal point in the field of orthopedics.

Three-dimensional (3D) printing in orthopedics enables the customization of implant geometry to meet patients’ individualized treatment needs. While the use of standard off-the-shelf components results in a mismatch rate of one in five orthopedic patients, this issue can be resolved through patient-specific 3D-printed customization. Furthermore, the fine porous structures created by 3D printing facilitate bone tissue ingrowth.

ButPreviously, 3D-printed orthopedic implants in China faced challenges such as complex operational procedures, time-consuming processes, and high costs.. According to Yu Xianzhu: “On one hand, there is the challenge of limited printable materials; currently, few biomaterials are suitable for 3D printing, with metallic prostheses being the primary option. On the other hand, there is the challenge of integrating medicine and engineering in the application process, as operators must possess knowledge in medicine, imaging modeling, and materials science, thereby hindering translational application.”

Furthermore, the evaluation framework for orthopedic 3D printing materials faces bottlenecks. The specific microporous structures of these materials impose stringent requirements on raw materials and fine structural precision, making it difficult to establish unified standards for bone trauma applications.

Tricalcium phosphate solid solutions are themselves smart materials, highly suitable for three-dimensional printing processes. Moreover, this material is easy to sinter and can be fabricated using techniques such as selective laser melting (SLM). Meanwhile,Yu Xianzhu developed a casting-like external mold 3D printing and cold sintering process for porous materials to manufacture controllable degradable, active, high-strength bone and dental materials with specific lesion morphologies.. This is a printing technology that involves moisture-cured ceramic clay printing of lesion shells, followed by further filling with calcium phosphate solid solution porous scaffolds.

This technology enables maturely developed biorthopedic materials to directly assume the specific geometry of the lesion, including porous tantalum alloys, titanium alloys, and ceramic scaffolds. It eliminates the need to consider the influence of raw material morphology and dimensions on the 3D printing process, thereby avoiding the drawbacks of directly using 3D printers to shape material microstructures and preventing changes in material properties during 3D printing. This breakthrough addresses the long-standing industry bottleneck of lacking unified standards.

Fengxi Medical initially applied this technology to tantalum-based orthopedic materials. Tantalum exhibits excellent biocompatibility, minimizing the risk of immune rejection in the human body. Moreover, its elastic modulus is closer to that of bone tissue, leading to widespread recognition within the 3D printing industry for orthopedics in recent years. However, as a refractory metal with a high melting point, tantalum requires specialized 3D printing equipment, often costing tens of millions of yuan, which hinders its widespread adoption in primary healthcare institutions.

Furthermore, cold sintering technology for calcium phosphate solid solutions can reduce the sintering temperature of metals such as tantalum and titanium, eliminating the need for expensive electron beam melting. This enables low-temperature sintering manufacturing using conventional 3D printers, thereby further promoting the widespread adoption of 3D-printed orthopedic materials.

Currently, although 3D printing has not become a key focus of China’s centralized procurement programs to the same extent as orthopedic consumables, certain areas within the 3D printing sector are already involved in such initiatives. The “National Centralized Procurement Plan for Spinal Medical Consumables (Draft for Comments),” released by the China Association of Medical Equipment, states that 3D-printed products may voluntarily participate in centralized procurement, with enterprises forming their own product systems. For Fengxi Medical’s 3D printing business, centralized procurement presents a significant opportunity.

Because Fengxi Medical’s cold-sintering materials can be supplied as consumables to various enterprises, they enable the sintering of titanium and tantalum alloys at lower temperatures, thereby reducing energy consumption. These materials are widely applicable in the manufacturing of 3D-printed medical devices and can be provided to hospitals as a 3D printing consumable.

In the global biomedical materials market, orthopedics and cardiovascular applications have the highest demand, followed by dental implants, with plastic surgery biomedical materials coming next.

China, with its massive population, is a major global market for orthopedics. On one hand, the accelerating aging of China’s population has created a substantial market for age-related orthopedic conditions. Meanwhile, rising living standards and the growth of the “appearance economy” have made medical aesthetics a new driver of market expansion. Additionally, the increasing number of vehicles has led to a rise in trauma cases from car accidents and other incidents, fueling robust growth in China’s domestic orthopedic market.

Fengxi Medical’s cold-sintered products primarily target the orthopedic market, including materials for bone trauma, joint, and spinal treatments, as well as orthopedic medical aesthetic fillers. Meanwhile, the company is strategically expanding into the dental aesthetics sector with products such as antibacterial orthodontic materials and antibacterial implant materials, thereby establishing its unique industrial advantages.

Fengxi Medical’s current core products are ultra-high-safety, cold-sintered, biodegradable medical alloy products designed for the aging population with impaired regenerative capacity. These include Class I and II surgical instruments with antibacterial and hemostatic properties, Class III porous scaffolds made from biodegradable titanium and tantalum alloys, and injectable aesthetic medicine materials. In the context of China’s volume-based procurement (VBP) policy, these products offer exceptional cost-effectiveness, facilitating market entry and scalable mass production.

The company’s TCPS intelligent tissue engineering scaffold integrates the comprehensive advantages of three commonly used material categories on the market. It addresses the susceptibility to infection associated with autologous bone grafts, combines the high strength and superior safety profile of metallic implants, and achieves chemical bonding with human bone through degradation-mediated osteogenesis, thereby avoiding the risk of loosening. Furthermore, it incorporates the beneficial properties of ceramic-based synthetic bones, such as osteoconductivity and biodegradability, while circumventing their drawbacks of high brittleness and compromised safety.

Materials are the foundation of medical devices, and the development of a material requires the integration of multiple disciplines, including materials science, medicine, and biology.

In 2018, Tianjin Fengxi Technology Co., Ltd. was formally established as the parent company of Fengxi Medical. Yu Xianzhu, Chairman of Fengxi Medical, completed both his bachelor’s and master’s degrees at the School of Materials Science and Engineering, Tianjin University, and has worked at renowned domestic research institutions specializing in frontier materials such as nanomaterials. The company’s chief medical expert is a nationally recognized specialist in orthopedics and orthopedic artificial intelligence. Additionally, the company houses an internal team dedicated to biology, with over ten years of deep expertise in material biology.

Only through the concerted efforts of professionals with multidisciplinary backgrounds can orthopedic materials with superior comprehensive performance be ultimately developed. As a company deeply rooted in the field of materials science, Fengxi Medical has actively sought support in the fields of medicine and biology, establishing strategic partnerships with companies such as Osida and Cell Therapeutics.

In the future, Fengxi Medical will leverage its unique industrial advantages in bone and dental integration to expand into the 3D printing sector. The company will actively establish industry-academia-research collaborations with major hospitals, secure an additional RMB 50 million in financing, and recruit top-tier talent in dental 3D modeling as well as academician teams specializing in orthopedic 3D printing. By establishing a 3D Printing Orthopedic and Dental Innovation Center, Fengxi Medical aims to cultivate highly skilled professionals integrating medical and engineering expertise, thereby overcoming bottlenecks in the 3D printing industry.