With the intensification of population aging, orthopedic problems such as cervical spine diseases, scoliosis, and bone defects emerge, and the orthopedic market contains more and more new opportunities. A mid-year review of the medical market in 2019 was made. This year, there were 9 orthopedic financings, all of which received financing for orthopedic implants. It is estimated that by 2022, the market size of orthopedic implants will reach 29 billion yuan.
Born Bio is a high-tech barrier company in the orthopedics industry. The company is good at making 3D printed artificial bones. Different from other competing products, Boen Biology is fulfilling the imagination of “making artificial bone alive” and is developing artificial bone that can “grow and develop” and induce cells to climb. In medical 3D printing, the most common application is orthopedics, which accounts for about 93% of the entire implant market. There are many orthopedic 3D printing teams, and the differences are very big, even the printing materials are also different. Domestically, it mainly focuses on metal and polymer materials. Internationally, most foreign manufacturers use hydroxyapatite and polylactic acid composite materials, and some orthopedic auxiliary devices use gypsum or resin materials.
The material of Boen Biological is very unique. It uses nano-hydroxyapatite material with a purity of more than 96%, and the binder is reduced to less than 4%. The artificial bone of Boen Biology is completely designed according to the density and composition of human bones. The hydroxyapatite material is also the same as the inorganic salt of human bones. It is degradable, so it can induce cells to climb and allow artificial bone to “grow” in the body. development”.
Nano-sized hydroxyapatite (HA) is a material that naturally has good osteoconductivity and osteoinductivity, but this material is difficult to make complex shapes, especially complex shapes with mechanical gradients and bionic structures. . As we all know, human bones have a clear distinction between cancellous bone and compact bone. In clinical practice, this is only meaningful if it meets the requirements of human mechanical properties, has a bionic structure, and guarantees the biological activity of the bones. Boen Bio not only achieves these characteristics, but more importantly, it is molded by 3D printing at room temperature, which avoids the death of biologically active factors in the artificial bone caused by high-temperature sintering, and also avoids the pollution problem of secondary disinfection. This is fully prepared for implantation in the human body.
Bio 3D printer independently developed by Born Bio
Born Bio has independently developed the world’s first developable bioactive bone 3D printer, and has completely independent intellectual property rights in terms of materials, manufacturing processes and manufacturing equipment. The 3D printing equipment can design digital models based on bone biomimetic design. By controlling the material composition and printing path, bones with different mechanical gradients can be manufactured, which fully realizes the characteristics of bone strength and compatibility. The team’s technology is sufficient for future mass production of implanted bones. Prepare.
Features of bio 3D printer:
▶Able to print bio-glue & bio-ceramic powder at room temperature
▶Able to realize multi-nozzle, multi-glue collaborative printing, with a resolution of 600X540Dpi
▶It can achieve high-precision printing, the layer thickness is adjustable from 0.05-0.1mm, and the minimum body size is 0.1mm
▶High printing efficiency, large printing size, product forming at one time
▶Large size high-definition touch screen, easy and quick operation
▶Have a rich material library, supporting material printing parameter package
▶Support input of STL, VRML and other format files
▶No noise, safe and tasteless, environmentally friendly
The technical difficulty facing medical 3D printing as a whole is how to ensure the consistency and stability of quality. Especially for customized invisible orthodontic braces, it is difficult to achieve industrialized mass production of personalized products. In order to ensure product quality, most companies still rely on manual production in processes such as cutting and polishing. On the other hand, Boen Biology already has self-developed highly automated equipment, which reduces manual intervention, basically realizes the intelligent manufacturing process, and realizes mass industrial production of personalized products. In this way, the stability and consistency of product quality can be guaranteed, which is another advantage of the company. In addition to strong strength in materials science, the team also has advantages in the development and production of intelligent manufacturing automation equipment.
In fact, the difficulty of orthopedic 3D printing lies not only in technology, but also in approval. It is difficult to obtain three types of medical device certificates. Because of the difficulty of obtaining evidence in orthopedics, 3D printing products did not have applicable evidence collection standards in the past. Customized products have led to a high cost of obtaining evidence, and each body part needs to apply for a medical device certificate.
The latest development is that in July this year, the country introduced a new policy, which is expected to bring a cardiotonic agent to medical 3D printing. This new policy is the “Regulations on the Supervision and Management of Customized Medical Devices (Trial)”, which stipulates the specifications for the filing management, design and processing, use management, and supervision and management of customized medical devices, which will be implemented in January next year.
Born Bio believes that the new policy is expected to bring a great boost to the industry, and the company is ready to participate in the review and approval when the policy is opened.
R&D companies need stable cash flow to collect payments. Then, while waiting for the three types of medical device certificates, how does Boen Biotechnology obtain revenue at present?
The research and development of the three types of medical devices itself is a high-investment, high-risk, and high-return industry. In order to solve the company’s cash flow problem before obtaining the three-category CFDA certification, Bone planned three categories of products from easy to difficult.
The first category: is the “preoperative human body rehearsal model” developed in cooperation with clinical hospitals. The product is characterized by more authenticity, with bionic blood vessels, skin, nerves, muscles, etc. The bones are tough, the mechanical properties are closer to the real situation of the human body, and the feel is more realistic. This is a category certified by the CFDA, and Born has applied for four first-class medical device certificates.
The second category: dental invisible orthodontic products. Although this product has many similar products on the market, the advantage of Boen Biological is the independent research and development of assembly line equipment, which transforms personalized and customized products into industrialized and mass production methods, and improves quality. Now that Born has applied for the production license of the CFDA Class II medical device registration certificate, it can be sold externally.
The third category: The developable artificial bone based on nano-hydroxyapatite has entered the fifth batch of animal experiments. According to the plan, it can enter the clinical application phase next year, and it is expected to enter the human experiment. In addition, Bohn has other product layouts in orthopedics and dentistry, which are under development.
The previous focus of Boen Biology was on research and development. Starting from this year, it will focus on sales. There are three methods: self-sales, agent sales, and OEM. It has received about 20 million orders, and the invisible aligner is OEM for an American company. . At the same time, Boen Biotech has also made a large number of public welfare products, providing free products for patients in need.
As for the future plan, Zhang Chi, head of Born Biotech, said, “What the company wants to do is human organs, and the entry point is orthopedics. The short-term goal is that artificial bones are consistent with human bones. I hope that this product can be recognized by the market within this time. , Born reserves a lot of technology, such as skin 3D printing technology, 3D printing technology for other tissues, and hopes to gradually develop other organs in the future. This is a matter of 30-50 years in the future. We believe that the combination of humans and machines in the future must be It will be the future trend. It is like installing a pacemaker in the body. This was a fantasy 60 years ago and has now become common sense. We believe that the combination of artificial organs and the human body will be more extensive in the future.”
Born Bio has completed two rounds of financing, the seed round is 4 million yuan, the investor is Zhongke Chuangxing, the angel round is nearly 10 million yuan, and the investor is an A-share listed company. At present, Boen Biological is seeking new financing, and the funds will be used for research and development and sales.
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