We believe that the future combination of people and machines will definitely be the future trend.

As the aging of the population intensifies, orthopedic problems such as cervical spondylosis, scoliosis, and bone defects emerge, and the orthopedic market has more and more new opportunities.

A mid-year resumption of the 2019 medical market, this year’s orthopedic financing is 9 All the financings are 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 in the orthopedics industry that excels at Make artificial bones in 3D printing. Unlike other competing products, Born Bio is contemplating the idea of ​​“making artificial bones alive” and is developing artificial bones that can “grow and develop” and induce cell climbing.

In medical 3D printing, the most common application is orthopedics, which accounts for approximately 93% of the entire implant market. There are many teams in orthopedic 3D printing, the difference is very large, even the printed materials are different. Domestically, it is mainly concentrated on metals and polymer materials. Internationally, most foreign manufacturers use hydroxyapatite and polylactic acid composite materials, and some orthopedic auxiliary devices use gypsum or resin materials.

3D prints into a future medical trend,

Bon Bio 3D Printing Products

Born Bio’s materials are very unique, using nano-hydroxyapatite materials with a purity of more than 96%, and the binder is reduced to less than 4%. Borne Bio’s artificial bone is designed according to the density and composition of the human bone. The hydroxyapatite material is also the same as the inorganic bone mineral component, which can be degraded, so it can induce cell climbing and allow artificial bone to grow in the body. development”.

Nano-grade hydroxyapatite (HA) is a natural material with good osteoconductivity and osteoinductivity, but it is difficult to make complex shapes, especially with mechanical gradients and biomimetic structures. Complex shape. As we all know, human bones have obvious distinction between cancellous bone and dense bone. In clinical practice, it only makes sense to meet the requirements of human body mechanical properties, have a biomimetic structure, and ensure the biological activity of bones. Born Bios not only realizes these characteristics, but more importantlyIt is formed by 3D printing at normal temperature, avoiding the death of bioactive factors in artificial bone caused by high temperature sintering, and avoiding the pollution problem of secondary disinfection. This is fully prepared for human implants.

Born Bio has independently developed the world’s first bioactive bone 3D printer, with complete intellectual property rights from materials, manufacturing processes and manufacturing equipment. The 3D printing equipment can design a digital model based on bone bionics, and by constructing bones with different mechanical gradients by controlling material composition and printing path, fully realize bone toughness compatibility characteristics, and the team technology fully prepares for mass production of bones in the future. ready.

The technical difficulty facing medical 3D printing is how to ensure the consistency and stability of quality. Especially for the customized invisible orthodontic braces, it is difficult to realize industrial mass production because of personalized products. In order to ensure the quality of the products, most companies still rely on manual production in the processes of cutting and grinding. Born Bio has already developed highly automated equipment, reduces manual intervention, basically realizes the intelligent manufacturing process, and realizes mass industrialized production of personalized products. As such, the stability and consistency of product quality can be guaranteed, which is another advantage of the company. In addition to its strong strength in materials science, the team also has advantages in the development and production of intelligent manufacturing automation equipment.

The Boen team has a total of 20 doctors and more than 30 masters, including 5 full-time R&D personnel, mostly from Northwestern Polytechnical University and Xi’an Jiaotong University, covering design, materials, chemistry, and equipment. The team has independently developed equipment, software, processes and materials.

3D prints into a future medical trend,

Bohn Bio 3D Printing Products

In fact, the difficulty of orthopedic 3D printing is not only technology, but also approval, it is difficult to obtain three types of medical device certificates. Because orthopedics are difficult to obtain, 3D printing products have no applicable forensic specifications in the past. Customized products lead to a large cost of obtaining evidence. It is necessary to apply for a medical device certificate for each body part.

The latest development is that the country introduced a new policy in July this year, which is expected to bring a boost to medical 3D printing. This new policy is the “Customized Medical Device Supervision and Management Regulations (Trial)”, which stipulates the specifications for the registration management, design processing, use management, and supervision and management of customized medical devices, which will be implemented from January next year.

Born Bio believes that the new policy is expected to bring a lot of boost to the industry, the company has doneBe prepared, and when the policy is open, you can participate in the approval.

R&D companies need stable cash flow returns. So, how do current Bonn biotechs receive revenue while waiting for three types of medical device certificates?

Developing three types of medical devices is a high-input, high-risk, high-reward industry. In order to solve the cash flow problem of the company before the three types of CFDA certification, Born has planned three types of products from easy to difficult.

  • The first category: is a “preoperative body rehearsal model” developed in collaboration with clinical hospitals. The product is characterized by more authenticity, with bionic blood vessels, skin, nerves, muscles and so on. 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 CFDA-certified category, and Bonn has applied for four Class 1 medical device certificates.

  • Second category: Dental invisible appliance products. Although there are many similar products in the market, Born Bio has the advantage of independently developing assembly line equipment, turning personalized and customized products into industrialized and batchized products. Production methods, improve quality consistency and stability, now Bonn has applied for a CFDA Class II medical device registration certificate production license, which can be sold externally.

  • The third category: The developable artificial bone based on nano-hydroxyapatite has entered the fifth experimental stage of the animal. According to the plan, it can enter the application clinical stage next year, and it is expected to enter the human experiment. In addition, Bonn is in the development of orthopedics, dental and other product layouts.

Born Bio’s previous focus was on R&D. Since the beginning of this year, it has focused on sales. There are three methods of self-sale, agent sales and OEM. Currently, it has received orders of 20 million or so. The invisible appliance is being used in the United States. Enterprise OEM. At the same time, Born Bio has also done a lot of public welfare products to provide free products for patients who need help.

As for future planning, Zhang Chi, the person in charge of Boen Bio, said, “The company wants to do human organs. The entry point is orthopedics. The immediate goal is that artificial bones and human body have their own bones. I hope the market can recognize this time. At the same time, Bonn stocks a lot of technologies, such as skin 3D printing technology and other organizations’ 3D printing technology. In the future, I hope to gradually develop other organs. This is the next 30-50 years. We believe in the future of people and machines. The combination will definitely be the future trend. It is like installing a pacemaker in the body. This is still a myth of 60 years ago. Now it has become common sense. We believe that the future combination of artificial organs and human body will be more extensive.”

Born Bio has completed two rounds of financing, with a seed round of 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. Born Bio is currently seeking new financing, which will be used for research and development and sales.