BASECARE-B(02170): GEMS Series Vitrification Solution and Thawing Solution Kit Obtains Class III Medical Device Registration Certificate Issued by the National Medical Products Administration

BASECARE-B(02170) announces that the company's Gems series vitrification solution kit and thawing solution kit have recently obtained Class III Medical Device Registration Certificates issued by the National Medical Products Administration (registration numbers: 20263180326 and 20263180338, respectively). The Gems vitrification-thawing solution kit originates from the same research and development system as the Gavi fully automated closed vitrification system. The entire reagent set is compatible with the Cryotop carrier rod widely used in domestic reproductive centers, and after appropriate adjustments, is also suitable for the Gavi fully automated vitrification instrument, accommodating the laboratory usage needs of both automated equipment and mainstream manual operations. In terms of formulation design, the Gems vitrification solution kit adopts a combination of two permeable cryoprotectants: DMSO and ethylene glycol. The combination of these two permeable protectants can effectively reduce the concentration of each individual reagent, and on the premise of achieving excellent vitrification results and inhibiting ice crystal formation, reduces the toxicity risk of chemical substances to embryos. The synergistic effect of the two components creates the prerequisite for embryos to rapidly achieve vitrification under liquid nitrogen conditions. In the selection of non-permeable protectants, both the Gems vitrification and thawing solution kits use trehalose to replace traditional sucrose. Trehalose is a naturally sourced disaccharide that does not penetrate into the cell interior, assists in the formation of the vitrified state, and reduces ice crystal formation. Throughout the entire freezing and recovery process, trehalose can stabilize the phospholipid bilayer of cell membranes as well as the structure of intracellular functional proteins. Compared with traditional sucrose formulations, trehalose can provide more comprehensive protection for embryo cells and reduce the risk of cell damage during the recovery process. As of the date of this announcement, the company's Gems series has achieved registration and certification for multiple core reagents, with the product matrix continuing to expand. The certified products include egg retrieval fluid, sperm washing fluid, fertilization culture medium, cleavage embryo culture medium, blastocyst culture medium, embryo culture medium, and embryo treatment fluid. Combined with the newly approved vitrification solution kit and thawing solution kit, the product chain now covers all core stages of "egg retrieval sperm processing fertilization in vitro embryo culture embryo freezing embryo thawing." From gamete processing to embryo culture and development, and then to embryo cryopreservation and recovery preservation, the Gems series is gradually building a complete embryo laboratory reagent product matrix.