Cardiolink Science Achieves Major Domestic Breakthrough with Simultaneous Launch of Blank and Drug-Eluting Embolic Microspheres

On March 15, 2023, Cardiolink Science(Shenzhen)Medical Technology Development Co., Ltd. ("Cardiolink Science"), an innovative leader in the field of tumor vascular interventional therapy, received approval from the National Medical Products Administration for its self-developed, next-generation embolic microsphere product, which it owns full intellectual property rights to. This is the first microsphere product in China to be validated by a pre-market RCT clinical trial.

This product not onlyResolved the bottleneck technology of 100% patent layout embolization and drug-loaded microspheres in China, and creatively developed a new generation of "biomimetic core-shell structure" embolization microspheres, completing industrialization. This effectively fills the gap in domestically produced technology and products in the field of tumor interventional TACE therapy.

Transarterial chemoembolization (TACE)-centered multidisciplinary treatment (MDT) is the mainstream consensus in cancer treatment, especially for liver cancer. This procedure holds an unshakable position in the treatment of primary liver cancer.

Experimental data have shown that TACE combined with other treatment methods (such as surgery, ablation, immunotherapy, and targeted therapy, etc.) has significantly better tumor treatment effects. Throughout the treatment process, TACE can reduce tumor size and downstage the tumor stage while enhancing the therapeutic effects of other treatments. Currently, localized combined systemic treatment centered on TACE has nearly become the primary choice for liver cancer treatment among hepatology experts in China.

Embolization materials are an indispensable part of TACE, and their value goes without saying. In the past, TACE procedures typically involved mixing emulsions of chemotherapy drugs with iodized oil thoroughly, then using gelatin sponge particles, polyvinyl alcohol particles, and others as embolic materials for surgical treatment. However, due to factors such as individual differences in doctors' operations, precise embolization has been difficult to achieve.

The emergence of microsphere technology has greatly addressed this issue, while meeting the needs for "long-lasting" maintenance of "localized" effective drug concentration, as well as controllability and safety of drug release. The "Guidelines for Diagnosis and Treatment of Primary Liver Cancer (2022 Edition)" has incorporated the surgical procedures involving drug-loaded microspheres, acknowledging that in terms of objective response rate in tumor treatment, the relatively new drug-eluting beads (D-TACE) hold certain advantages over conventional chemoembolization (c-TACE).

But it is not easy to complete the R&D in the fields of c-TACE and D-TACE.Embolic Microspheres(Especially drug-loaded microspheres)The "bottleneck" lies not only in the extremely high R&D, patent, and production barriers, which require support from knowledge systems such as synthetic chemistry, biochemistry, microelectronics, pharmacology, and immunology, but also in challenges related to embolic microsphere materials, particle size, durability, and toxicity, which need to be addressed through technical means.

At this stage, manufacturers can hardly fully meet the above requirements and achieve product implementation. Although different embolic microspheres made of various materials, with different particle sizes, and offering different functions have been developed, most products are still in the experimental stage, and there are only a few approved products in the Chinese market. Previously, only products from three companies were approved for marketing in China: Biocompatibles (UK), BioSphere (USA), and Hengrui Galil Medical, with Hengrui Galil Medical being the only Chinese manufacturer.

As an innovative enterprise in China, the embolic microsphere product approved this time by Cardiolink Science is undoubtedly a major breakthrough in this field.

In general, ideal embolic microspheres should possess good biocompatibility and be non-toxic to the human body; have controllable embolization time; carry drugs themselves with a high drug-loading capacity; meet the needs during and after the procedure; be easy to deliver, resistant to fragmentation, and have migration capability, among other characteristics.

The embolic microsphere product approved this time for Cardiolink Science nearly meets all of the above requirements. Particularly worth mentioning is that,The team invented a new generation of "bionic core-shell structure" with independent intellectual property rights, inspired by the cell shell structure. This is one of the most valuable technological breakthroughs in the product.

It is reported that the structure hasExcellent physical properties (toughness, elasticity, etc.) and drug-loading performance, enabling the microspheres to more closely mimic the morphology of real human cells, thusEnhance the toughness, elasticity, and plasticity of drug-loaded microspheres, enabling them to enter more distal blood vessels and quickly rebound after reaching the lesion site to achieve peripheral embolization/precise embolization.

At the same time, “Bionic Core-Shell Structure"It also endows the product with superior biochemical properties, enabling high-efficiency drug loading and stable drug release rates, reducing the drug-loading process from 30 minutes to 5 minutes, making surgeries more convenient, further saving operation time, and improving the efficiency of doctors. From the perspective of health economics, it reduces the burden on patients."

Not only that,Cardiolink Science has mastered core technologies such as GCL gradient cross-linking and IPN molecular interpenetrating networks, and possesses full independent intellectual property rights. It has achieved a breakthrough in the technology of a new generation of drug-loading embolic microspheres with excellent comprehensive performance., achieving fast drug loading and stable sustained release, thereby achieving a better reduction in systemic drug concentration and minimizing toxic side effects. This addresses various clinical needs regarding the physical properties, drug-loading, and drug-release performance of microspheres, essentially meeting the requirements for ideal embolic microspheres.

Currently, Cardiolink Science has established a complete industrial ecosystem chain and achieved product registration approval and large-scale batch production. As a start-up enterprise, the simultaneous market launch of Cardiolink Science’s blank microspheres and drug-loaded microspheres marks a significant breakthrough in independent innovation for domestically produced medical device companies. The ability to emerge as a leader in the embolic microsphere field, dominated by giants, and break the monopoly of imported technology also serves as a testament to the strength of this company.

According to the latest data from the International Agency for Research on Cancer (IARC) of the World Health Organization, liver cancer has become the malignant tumor with the highest incidence in China, with 410,000 cases and about 390,000 deaths. Among them, the number of deaths ranks second among all types of cancer.

Nowadays, with the improvement of people's living standards and the intensification of population aging, the incidence of liver cancer continues to rise. This not only imposes a heavy burden on China’s society and healthcare system, but more critically, the efficacy of mainstream treatment methods in China is limited, and the number of available treatment options is also fewer compared to developed countries.

After more than 30 years of development, TACE has evolved into three main techniques: conventional transarterial chemoembolization (c-TACE), drug-eluting bead transarterial chemoembolization (D-TACE), and transarterial radioembolization (TARE). Embolic microspheres are being increasingly used in TACE procedures.

Among them, blank microspheres, as a new generation of embolic material, can be applied in c-TACE, allowing for a more uniform mixture of chemotherapy drugs and embolic agents, achieving precise embolization of the target blood vessels, thereby realizing the precision and uniformity of c-TACE.

Drug-loaded microspheres used in D-TACE fully leverage the advantage of sustained-release properties, minimizing drug release during delivery and precisely transporting chemotherapeutic agents to the vicinity of the tumor. This enables accurate localized drug administration while maintaining a higher concentration of the drug for a longer period, providing prolonged and continuous sustained release directly to the tumor. Moreover, these drug-loaded microspheres maintain a balance between rigidity and elasticity, allowing rapid rebound after compression implantation and forming a tight bond with the blood vessels. This represents the future trend in precision tumor treatment.

It is precisely because of the value and high barriers of this technology that TACE has become a blue ocean market with insufficient competition and promising future. According to a set of data released by Data Bridge, by 2028, the market size of embolic microspheres in TACE is expected to reach 3.4 billion US dollars; the entire TACE application market size may exceed 10 billion US dollars.

In the future, with the continuous improvement and enhancement of related technologies, TACE will not only be applicable to the treatment of malignant tumors, bleeding, uterine fibroids, and other diseases but will also continuously expand its range of applications. The development of imaging technology and equipment, material science, and drug-release technology will also drive the market to introduce more microsphere embolic products capable of drug-loading, self-imaging, or possessing multiple functions, further benefiting patients.

This is also the significance of Cardiolink Science, as a platform company providing comprehensive solutions for minimally invasive interventional tumor treatment, persistently adhering to the integrated development path of independent research and development, production, supply chain, and sales, continuously tackling and resolving bottleneck issues in the interventional field.

On March 18, the day marked China's National Liver Health Day and also the second anniversary of the first clinical enrollment for Cardiolink Science's microsphere product.

Looking back, Che Haibo, founder of Cardiolink Science, stated: "In the field of TACE, which is almost monopolized by giants, making a breakthrough requires not only the hard power of the company but also sweat and effort. During the R&D process, Cardiolink Science aimed for the scientific research high ground, combining 'genius and sweat' to solve the bottleneck technology of drug-loaded microspheres, ultimately achieving technological innovation and completing industrialization. As a fast-moving team guided by lean thinking and result-oriented principles, we start with the end in mind, identify the crux of the problem, and set clear goals to resolve it. It is precisely because of this that we are able to move forward with determination on this path and achieve breakthroughs."

Since its establishment nearly eight years ago, Cardiolink Science has adhered to the evidence-based logic of "being a doctor's confidant" to identify clinical needs. It has also insisted on therapy-driven approaches to seamlessly integrate technical engineering language with clinical requirements, further building its core competitiveness and achieving rapid growth.

Currently, Cardiolink Science has achieved a full solution in the TACE field and obtained 15 Class III medical device registration certificates. The recent approval and market launch of its self-developed embolic microspheres not only signifies the recognition of the product’s performance and clinical trial results, but also makes it the first company with domestically produced intellectual property rights to be validated through RCT trials. This is a testament to the comprehensive capabilities of Cardiolink Science's team and the correctness of their methodology.

Reference Article:

1. Research Progress of Arterial Embolization Microspheres

2.White Paper on China's Interventional Medicine (2021 Edition)

3. The Current Status and Future Prospects of Liver Cancer Research in China

4.2020 Survey and Analysis on the Current Status of Tumor Interventional Diagnosis and Treatment in Henan Province