ClarVision's Bioabsorbable and Biodegradable Microspheres Receive FDA Breakthrough Device Designation, Pioneering an 'Intervention Without Implant' Era

The U.S. FDA's "Breakthrough Device Designation" (BDD) certification, initiated in 2015, aims to expedite the review process for innovative medical devices that address life-threatening or irreversibly debilitating diseases by providing more effective treatment or diagnostic methods. The BDD evaluation criteria are extremely stringent, requiring the product to offer a more effective treatment or diagnosis for life-threatening or irreversibly debilitating conditions, represent breakthrough technology, demonstrate significant advantages over existing alternatives, and align with patients' best interests. Therefore, the BDD designation is regarded as one of the highest symbols of innovation value in the global medical device field.

Recently released data from the FDA shows that since 2015, only 1,176 products worldwide have received this honor. Among them, the cardiovascular field, known as one of the most technically challenging and innovation-dense areas, has seen only 243 products selected. Cardiolink Science's bioresorbable and biodegradable embolic microspheres have stood out from countless products under development globally, becoming one of the highly significant "1,176." This is not only a proud achievement for Cardiolink Science but also a strong testament to the international recognition of China's innovative capabilities in the high-end medical device sector.

Embolic microspheres are one of the most common embolic materials used in clinical practice. They are categorized into non-degradable microspheres and degradable microspheres based on whether they can degrade. Currently, non-degradable embolic microspheres are primarily used in clinical applications. Non-degradable embolic agents often cause severe inflammatory reactions, hindering subsequent treatments. Therefore, biodegradable embolic microspheres have attracted widespread attention. The biodegradability enables short-term embolization of the target blood vessels, significantly reducing risks such as post-embolization syndrome, tissue inflammation, and fibrosis, increasing the possibility of repeated interventions after vascular recanalization. Meanwhile, these microspheres allow for multiple embolizations, avoiding issues of lesion recurrence caused by incomplete occlusion of regenerating vessels or collateral vessels.

Cardiolink Science's bioresorbable and biodegradable embolic microspheres represent an important future direction in embolic technology. Compared with traditional non-degradable permanent embolic materials, this product has achieved several major breakthroughs:

Cardiolink Science's leading layout in this field demonstrates its profound insight into clinical needs and precise grasp of future technology trends.

"Based on therapeutic reading, reconstructing local immune ecology, and constructing targeted therapeutic devices and drug delivery systems for continuous cell apoptosis and death."Cardiolink Science, with the concept of "Therapy Reading," innovates embolic materials, leading TACE therapy from conventional embolization to refined/precise embolization and immune embolization (TAICE), promoting the real-world hepatocellular carcinoma treatment concept to delve from the tissue and organ level into the cellular level.

The company continues to focus on the research and development of embolic materials, establishing a leading technology platform in the industry for targeted embolization therapy and precise drug delivery systems based on medical hydrogel materials. This platform covers multiple critical aspects including material science, precision processing, integration of pharmaceuticals and devices, and clinical validation. Such deep independent research and development capabilities are the fundamental guarantee for continuous product innovation and iteration.

Based on a deep understanding of embolic microsphere products and full-stack development capabilities, the company, as the leading drafting entity, participated throughout the process."Polyvinyl Alcohol Embolization Microspheres Group Standard" (T/CSBM 0053-2024)Content writing and verification, collaboration with academic societies, university experts, and industry peers, made significant contributions to the introduction of the standard.⁵。

Based on an in-depth interpretation of the real clinical needs for the development of TACE, Cardiolink Science has constructed an embolic microsphere product matrix through refined structural design and functional iteration, continuously leading the technological advancement of microspheres.

Receiving the FDA Breakthrough Certification marks a new starting point. Cardiolink Science will continue to accelerate the clinical research and registration of this product, promoting the early application of this innovative technology in clinical settings for the benefit of patients in China and even globally. Meanwhile, the company will continue to uphold the concept of "Therapy Reading" and explore further within the broader field of vascular intervention.

Looking ahead, Cardiolink Science will continue to carry the mission of creating value for human health, forging ahead through the vast ocean of medical technology and continuously leading the way!