Evidence-Based Foundation, Full-Stack Leadership: Cardiolink Aims to Be the Undisputed Leader in Embolization with Comprehensive Evidence Chain and Full Product Portfolio

Recently, Cardiolink Science has once again achieved success.：Cardiolink Science^® DiaSphere^®After the embolic microspheres completed the first pre-market RCT study in China, the post-marketing clinical research paper was published on May 18 in the authoritative journal "Journal of Interventional Radiology.". Research¹Shows that, in real-world applications, DiaSphere^®Embolic microspheres demonstrate excellent safety and short-term efficacy, with a technical success rate of 100% and a disease control rate (DCR) exceeding 95%.⁵. This is a new milestone for the product, and more importantly, a solemn practice of "evidence-based medicine" by Cardiolink Science — ensuring that every innovative product is supported by solid clinical data, both before and after its market launch.

“Based on therapeutic reading, reconstructing local immune ecology, and constructing targeted therapeutic devices and drug delivery systems for continuous cell apoptosis and death.”Outstanding instruments stem from a profound insight into the underlying logic of therapy evolution. Guided by this philosophy, Cardiolink Science has established a comprehensive, full-matrix instrument solution covering the entire process of embolization treatment. From the cornerstone of TACE for liver cancer to the exploration of multi-organ applications, and from localized embolization to targeted immune synergy,Cardiolink Science, Determined to Be the "Strongest" in the Embolization Field.

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1. Evidence-Based Foundation: Five-Level Evidence Chain, Forging the Gold Standard of Evidence-Based Practice

As a leader in the field of embolization intervention, Cardiolink Science has established a globally leading microsphere technology platform, which continues to iterate and evolve. We deeply understand that the ultimate value of innovation lies in bringing definitive clinical benefits to patients. Therefore, we have built a complete chain of evidence-based proofs within the industry:

• New Evidence from Post-Market Studies¹: This Ruiyuan^® DiaSphere^®Post-marketing Study: A Prospective, Multi-center Trial Including 34 Patients with Primary Hepatocellular Carcinoma. The results showed that the Objective Response Rate (ORR) in the study group reached 64.71% one month after the first TACE, and the Disease Control Rate (DCR) reached 97.06%. Adverse events were mild to moderate, and there was no significant difference in liver function compared with the screening period. This study confirmed the efficacy of DiaSphere.^®Short-term Efficacy and Safety in Real-world⁵。

• Review the Past, Break New Ground：

Rui Yuan^®RCTResearch²: The first pre-market RCT study in the field of embolic microspheres in China, led by Professor Zou Yinghua from Peking University First Hospital, in collaboration with 11 top-tier tertiary hospitals in China. This study fills the industry gap and has been published in the "Chinese Journal of Interventional Imaging and Therapy," with results confirming DiaSphere.^®Short-term efficacy and safety of TACE treatment for HCC using embolic microspheres are favorable⁵。

Flash Abyss^®FIMResearch³：The first-in-human (FIH) study of the world's first visualizable uniform-sized bionic core-shell embolic microsphere was published in the Journal of Interventional Radiology. The results showed that: the ORR reached 100% and the DCR reached 100% one month after surgery; all lesions achieved 25%-100% regional imaging; no serious adverse events above grade 3 occurred.⁵。

So far, Cardiolink Science has established"In Vitro Performance Study —— Cell/Small Animal - Large Animal Trials - Pre-market RCTClinical Research - Post-Market Real-World Study'sFive-level Complete Evidence Chain. This is not only a manifestation of Cardiolink Science's confidence in its products, but also a solemn commitment to every life.

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2. The Strength of Microspheres: Deep Technical Expertise Driving Generational Leap

（1) From Therapy Reading to Product Iteration: Leading the Development Trend of Microsphere Technology

Cardiolink Science always adheres to the R&D concept of "Therapy Reading," deeply understands the evolutionary trend of embolization therapy from "general embolization" to "precise embolization" and from "local treatment" to "immune synergy," and uses this as a blueprint to drive the continuous iteration of microsphere products. From structural breakthroughs to functional elevation, we provide clinical solutions that surpass current needs through forward-looking engineering practices.Respond to Every Evolution in Therapy:

• Zhiyuan^®/Ruiyuan^®: With the original "bionic core-shell" design, it has achieved a simultaneous leap in mechanical properties and drug-loading/drug-release performance, becoming the first embolic microsphere in China to complete pre-market RCT research, and was included in the TACE guidelines in 2023.Leap渊^®: Minimum 70μm, uniform particle size, small particle size ready to use in 1 minute, pushing precise embolization to a new level of distal dense embolization.

Yuyuan^®: The first domestically produced uniform-sized blank microspheres in China for uterine fibroid embolization, enabling embolization treatment for multiple diseases;Flash Abyss^®: The world's first visualizable uniform-sized bionic core-shell drug-loaded microsphere, providing stable and continuous imaging, making the embolization process "what you see is what you get"; Biodegradable Absorbable Microspheres: Honored with FDA Breakthrough Device Designation, controllable degradation time, fully absorbable, ushering in a new era of "intervention without implantation";PhysicsADC Microspheres: A global first, using microspheres as carriers for the precise delivery of broad-spectrum drugs such as targeted/immunotherapy drugs, advancing the concept of "Targeted Augmented Immune Chemoembolization (TAICE)" into reality.

Through six generational leaps, Cardiolink Science, with "Therapy Insight" as its engine, continues to lead the future direction of embolization treatment.

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(II) From Product Innovation to Industry Standards: Defining Rules with Strength

Cardiolink Science not only focuses on developing leading products but also is committed to "building systems and setting standards" — leveraging its technical expertise and clinical insights to promote standardized development across the industry. This is the deeper meaning of being a "pioneer": it’s not just about moving fast alone, but also paving the way with milestones for the entire track.

• Take the lead in formulating industry standards：As the first corporate drafting entity, Cardiolink Science fully participated in the writing and validation of the "Polyvinyl Alcohol Embolic Microspheres Group Standard" (T/CSBM 0053-2024).The release of this standard fills the gap in China's embolic microsphere field, demonstrating Cardiolink Science's responsibility and commitment to promoting standardized and high-quality development in the industry.

• Included in authoritative clinical guidelines：Rui Yuan^® DiaSphere^®Embolic Microspheres Included in the "Clinical Practice Guidelines for Transarterial Chemoembolization (TACE) Treatment of Hepatocellular Carcinoma in China (2023 Edition)"，Becoming the embolic microspheres simultaneously recommended by guidelines and validated by pre-market RCT marks that the product has passed rigorous clinical testing and gained recognition from high-level evidence-based medical evidence.

• Awarded Recognition as a Provincial Engineering Technology Research Center：In 2025, the company was successfully recognized by the Guangdong Provincial Department of Science and Technology as"Guangdong Provincial Engineering Research Center for Tumor Interventional Medical Devices", marking that Cardiolink Science has reached a new height in technological innovation, achievement transformation, and industry leadership.

From drafting microsphere standards and including products in guidelines to obtaining recognition as a provincial engineering center, Cardiolink Science is transforming its own innovative potential into systematic momentum that propels the entire industry forward. This is the true essence of a "pioneer."

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3. Completeness of Therapy: Matrix Tools, Building a Full Ecosystem for Embolization Treatment

Cardiolink Science provides a matrix-based device solution covering the entire embolization treatment process:

• Series Embolic Microspheres: From blank, drug-loaded, to visualizable and biodegradable, from uniform particle size to broad-spectrum drug loading, covering the full range of particle sizes from 70μm to 1200μm, meeting the embolization treatment needs for various benign and malignant diseases such as liver cancer, lung cancer, uterine fibroids, kidney cancer, prostate cancer, and osteoarthritis.

• Series Microcatheter: Provide full-spec microcatheters ranging from 1.6F to 2.7F, with "High Torque, High Throughput, Full Range of Models"As the core advantage, meeting various clinical scenarios from common super-selective to ss-TACE. Offering multiple series including Zhi Jiao, Rui Jiao, Zhi Hong, Zhi Peng, and Zhi Yu, with diverse tip shapes (straight, 45°, 70°, J-shaped, cobra-shaped, swan-neck shaped, etc.), and lengths ranging from 105-180cm."

• Special Access Tool：Wisdom Brush^®The adjustable bend microcatheter is the first domestically produced product of its kind to be approved in China, easily handling complex anatomical structures.Zhi Xiu^®The distal outer diameter of the balloon microcatheter is only 1.9F, which can block blood flow through the balloon, achieving pressure-directed precise embolization;Zhi Guan^®Micro guidewire receives EU CE certification, featuring excellent maneuverability and kink resistance.

• Coming Soon:Embolic Coils - At that time, Cardiolink Science will complete a full product line闭环, ranging from access to embolization, from microspheres to coils, from permanent to biodegradable, and from solid tumors to vascular malformations, potentially becoming the company with the most comprehensive product line in the field of embolic treatment in China.

"Comprehensive" is the strong label of Cardiolink Science in the embolization field. In terms of R&D, the full-stack technology platform achieves complete autonomy and control across the entire chain from materials to clinical applications; in terms of products, the matrix-style product family meets all clinical scenario needs for embolization treatment; in terms of therapy, it provides comprehensive solutions covering the entire process from access establishment to post-operative evaluation. This all-encompassing layout has established Cardiolink Science as a leader in the embolization field.

Full Stack Leadership, Defining the Future

From the rigorous pursuit of truth in five-level evidence chains, to the generational leap in microsphere technology, and further to the comprehensive layout of matrix-based tools, Cardiolink Science has defined itself as the "Leader in Embolization" through action. We are not only providers of devices but also definers of treatment paradigms — from structural innovations in "biomimetic core-shell," to precise navigation with "visualization," and further to targeted-immune synergy in "physical ADCs," Cardiolink Science consistently remains at the forefront of embolization therapy.

In the future, Cardiolink Science will continue to use full-stack technology as its engine, join hands with medical professionals worldwide, overcome challenges together, and create the future!

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Note:

[1] Zhang Q, Tu J, Jin Y, et al. Safety and efficacy of the novel bionic core-shell structured drug-loaded microsphere DiaSphere for hepatocellular carcinoma[J]. Journal of Interventional Radiology, 2026, 35(5): 509-513.

[2] Yao Hang, Hu Hongtao, Cao Huicun, et al. DiaSphere embolic microspheres TACE for primary hepatocellular carcinoma: A prospective multicenter randomized controlled study[J]. Chinese Journal of Interventional Imaging and Therapy, 2025, 22(6): 375-379.

[3] Tu Jianfei, Sun Hongtao, Sun Peng, et al. Efficacy of TraSphere Visible Embolic Microspheres for Transarterial Chemoembolization in Hepatocellular Carcinoma[J]. Journal of Interventional Radiology, 2026, 35(3): 319-323.

[4] Clinical Research Report on the Safety and Efficacy of Using Contrast-Enhanced Embolic Microspheres for Transarterial Chemoembolization in Liver Cancer. P18

[5] The content of this article aims to help healthcare professionals better understand the latest advances in related disease areas, for learning and exchange only. The data in the article are based on a certain sample size, and the results have limitations. They do not constitute a guarantee of product efficacy and safety, and should be understood cautiously in conjunction with the complete clinical evidence of the product. This information cannot replace professional medical guidance in any way and should not be considered as diagnostic or treatment advice.