Bench-to-Bedside Translation of Self-Healing Colloidal Hydrogels as Next Generation Design of Flowable Hemostatic Matrix: From Preclinical Evaluation to Human Clinical Trials.

Self-healing materials represent a paradigm shift in designing functional biomedical devices for drug delivery, tissue regeneration, and 3D bioprinting. However, their clinical translation remains limited by challenges such as insufficient mechanical strength, potential cytotoxicity from chemical modifications, and complex activation requirements. Here, we report the development of a self-healing colloidal gelatin hydrogel engineered as a flowable hemostatic matrix and successfully demonstrate its bench-to-bedside translation into a biomedical device (Colloidose). Specifically, amphoteric gelatin sub-microparticles self-assemble into an integrated gel network exhibiting a high storage modulus (G' > 15 kPa) and a healing efficiency exceeding 95%, enabling rapid in situ solidification to accelerate blood clot formation. By benchmarking against conventional flowable matrices composed of coarse hundreds of micrometer-sized gelatin granules, we demonstrate that Colloidose offers superior hemostatic efficacy in anatomically challenging or pressure-intolerant sites (e.g., hepatobiliary, otorhinolaryngological, and gynecologic surgeries). Supported by comprehensive preclinical studies and over 300 clinical cases, Colloidose exemplifies the successful translation of an advanced self-healing biomaterial, establishing its role as a next-generation hemostat and opening new avenues for injectable and moldable biomedical devices.