Lixin Scientific's HercuRegen™ Absorbable Interference Screw Gains NMPA Approval, Pioneering a New Generation of Regenerative Biomaterials
Corliber
Developer of Novel Biomaterials and Orthopedic Implant Medical Devices
Recently, Corliber's HercuRegenTMAbsorbable Interface Screws Approved for Marketing by NMPA: Corliber's Breakthrough in Medical-Grade Composite Raw Materials
This product is the first major release by Corliber based on a new generation of high-performance biodegradable composite materials. It can be used in knee, shoulder, elbow, ankle, and wrist joint surgeries to fix bone-tendon-bone or soft tissue grafts to bone tissue.
Corliber Absorbable Interface Screw HercuRegenTMProduct Introduction
In the past few years, limited by raw materials and R&D technology, the high-end products in China's biomaterials market have always been firmly occupied by overseas brands. Now, with the approval of Corliber's absorbable interface screw product, the market door for scalable medical-grade composite materials produced in China will be opened.
At the same time, Corliber, as an innovative enterprise that has received much attention, enters the regenerative biomaterials industry with its technical and industrial chain advantages. It will lead numerous domestically produced innovative enterprises into the market, promote market cultivation, and benefit more patients.
Orthopedic Sports Medicine is a branch of orthopedic medicine and sports medicine, aiming to achieve maximum functional restoration with minimal trauma.
Orthopedic sports medicine in China began to emerge around 2000 and, after more than a decade of development, the market has started to take shape. According to the report, the size of China's sports medicine market exceeded 2 billion yuan in 2018.The sports medicine market size is expected to have a compound annual growth rate of 23.4% from 2015 to 2021, ranking first in growth compared to traditional orthopedic fields such as trauma and spine.
Among them, interference screws are fundamental internal fixation products in orthopedic sports medicine. Interference screws used in clinical settings need to have high screw strength, good biocompatibility, and strong processability, thus presenting a generational development relationship. They are roughly divided into medical-grade titanium materials, first-generation absorbable materials, medical-grade PEEK (polyetheretherketone) materials, and next-generation absorbable materials. Among these,PEEK is currently the mainstream clinical material, but the raw material suppliers are firmly controlled by imported enterprises.
With the changes in clinical needs and market environment,Internally fixed products made of high-performance, absorbable, and regenerative materials produced in China will become the inevitable choice.
According to Corliber, the annual demand for absorbable interface screws in China is approximately 120,000 units, and the growth rate is continuously increasing. However, due to high industry technical barriers and patent technology封锁等,Absorbable interface screws have been completely monopolized by imported products.
Faced with such a "stranglehold" situation, the core team of Corliber decided five years agoTaking the path of long-term accumulation and technical breakthroughs, conducted a large amount of foundational research to build the material platform. Corliber adoptsFully self-developed and produced customized polylactic acid raw materials and unique super-dispersed composite technology, making HercuRegenTMAbsorbable Interface ScrewCombining Strength and Toughness。
According to Corliber, HercuRegenTMAfter implantation, it exhibits a hydrolysis self-locking effect.Can achieve super strong fixation, complete degradation and absorption, while possessing superior osteogenic performance to promote bone tissue regeneration., and can also avoid the need for patients to undergo a second surgery to remove internal fixation products after their wounds have healed.The clinical benefits for patients and the health economic benefits are both considerable.
Among various interface screw materials,Metal, PEEK MaterialAlthough it has high strength, it is non-absorbable and often requires a second surgery to remove after the wound heals;Pure polymer materialAlthough absorbable, it tends to form fibrous tissue and trigger acidic inflammation after degradation, and lacks osteoinductive activity for bone healing.
Therefore, many companies have turned to research and development.Biodegradable Composite Materials, incorporating inorganic materials such as bioceramics to neutralize acidity while retaining certain osteoinductive activity, but both activity and strength need improvement.
AndCorliberHercuRegenTMAbsorbable interface screws adoptFourth-Generation High-Performance Biodegradable Composite Materials, composed of PLA (polylactic acid) / HA (hydroxyapatite) composite, withSuper strong fixation and high regenerative induction activity.
HA particles in PLA solution tend to settle gradually, and HA is difficult to disperse uniformly in an organic matrix, which limits the improvement of PLA/HA composite performance.
To improve the interfacial compatibility between HA particles and the PLA matrix, Corliber adopts a unique preparation process that reduces the energy barrier at the PLA/HA interface, achieving a uniform and fine dispersion of HA particles. This further enables directional distribution of polymer materials through self-reinforcement, significantly enhancing the strength and toughness of the final composite material.
The bending strength of the previous generation of degradable composite materials could only reach about 70% of that of cortical bone, whileHercuRegenTMStrength can reach twice that of cortical bone.
At the same time, Corliber's super-dispersion technology, which overcomes energy barriers, allows sufficiently fine and uniform HA particles to come into contact and fuse with cells, fully exerting their osteoinductive activity.Effectively Promotes Osteogenesis During Degradation.
According to Dr. Sun Yang, founder and CEO of Corliber, in the field of sports medicine, the endpoint of treatment that doctors generally focus on is tendon-bone healing. Currently, absorbable interface screws available on the market can meet the requirements for tendon-bone healing in the short term after implantation, butThe long-term effects are not entirely ideal.. The reason is thatThe degradation rate of the nail material is too fast, while the bone formation rate is too slow. When the two cannot offset each other, it is highly likely to result in bone cavities.
As for HercuRegenTMNot only can itTendon-bone healing completed within 6 months after implantation, and also inComplete degradation and absorption 3-4 years after implantation, achieve nail-bone healing, and ultimately realize regenerative repair.
In addition to absorbable internal fixation products, Corliber has also developed a range of regenerative implant product lines, including bone fillers, oral, and medical aesthetic absorbable polymers, based on the research and development of biodegradable medical polymer materials represented by polylactic acid.
Corliber Partial Production Lines
For absorbable internal fixation products, regulatory approval and market launch do not necessarily equate to meeting market supply demands, especially when the majority of raw materials are controlled by foreign enterprises. Against the backdrop of rising anti-globalization trends and the push for domestic alternatives in China,The guarantee of raw material supply and product mass production capacity is an important assurance for the operation of an enterprise.。
CorliberThe entire chain from upstream medical polymer raw material production to terminal product processing has been fully realized through self-research and self-production., its own factory and customized unique production process can help the pipeline's efficient R&D and continuous capacity expansion.
"The raw material production capacity will expand from the current 300 kilograms per year to two tons per year by next year, fully ensuring upstream supply. The downstream absorbable interface screw production line capacity will increase from 10,000 units per year to 50,000 units, meeting the rapid scaling needs of the product," said Dr. Sun Yang.
While ensuring mass production, Corliber remains strict about the "quality" of its products, always prioritizing the alignment with clinical needs. The Corliber team is composed of professional and low-key scientific research experts, and the company is located in Shenzhen, a city with a strong atmosphere of practical innovation, which has long embedded "pragmatism" deep into Corliber's DNA.
Therefore, Corliber has done quite a solid job in the integration of medical and engineering work. "The doctors we collaborate with are very diverse, and doctors of different qualifications and levels are our partners. We do not blindly believe in any demand but seek evidence from multiple sources. If at least six or seven out of ten people recognize it, we will consider that the demand is worth transforming into investment," introduced Dr. Sun Yang.
For this HercuRegenTMAbsorbable Interface Screw Approved: Dr. Sun Yang stated, "The moment we obtained the certification marked the end of the entrepreneurial phase of Corliber 1.0, officially stepping into the 2.0 era where technology begins to scale and commercialization kicks off. More importantly, this certification is the first crucial step in our long march. It signifies that Corliber's material platform has gained recognition from the pharmaceutical regulatory authorities, serving as a milestone accelerator for subsequent product development based on this platform."
"At the same time, Corliber has also set its sights on overseas markets. 'Although China is our base and the market we should serve the most, Corliber's goal is by no means limited to the Chinese market.'"
It is reported that Corliber's artificial bone product is the world's first absorbable artificial bone that can effectively meet the requirements of shapeability, anti-liquid dispersion, and high-efficiency induction of regeneration. The first-generation product is currently in clinical trials in China.Has taken the lead in submitting FDA certification and entered the supplementary stage.It is expected to be approved by the FDA in the first half of 2022, while preparing to submit registration to the China National Medical Products Administration.
Currently, Corliber owns more than 80 patents, including over 20 invention patents, and has formed fully independent intellectual property rights related to core composite materials. The patent protection scope covers the entire field of absorbable medical device technology, including raw materials, composite materials, and device structures, and has achieved a platform-based global patent layout.
Dr. Sun Yang stated that Corliber aims to export high-end technology, tap into the vast overseas market, and respond to the national strategy of building the "Belt and Road" by establishing a leading corporate brand image. However, achieving this goal cannot rely on the strength of a single company but must depend on the entire industry.
"There is still much room for improvement in China's medical polymer raw material industry. Many materials experts lack the right approach and appropriate opportunities to make conversions. We hope Corliber can use its energy and pragmatic corporate culture to lead peers in making achievements in the field of industrial transformation and upgrading. Although the next phase may be no less challenging than the earlier R&D stage, as always, being pragmatic and reliable will surely help us find a good way to survive. This is our fundamental judgment of our confidence," said Dr. Sun Yang.
References
1. "2020-2026 China Sports Medicine Joint Repair Devices Market Supply and Demand Scale and Investment Strategy Research Report"
2. "Study on the Properties of In-situ Polymerized PLA/HA Composites"