Good News | The 60th Certificate! Mednuo Medical Group’s Self-Developed Vitrification Warming Solution Kit Obtains Registration Approval

Recently, the Vitrification Warming Solution Kit independently developed by Mednuorui Medical Technology Co., Ltd., a subsidiary of Mednuo Medical Group, has been granted the Class III medical device registration certificate by the National Medical Products Administration (NMPA), with the registration number: Guoxiezhuzhun 20263181555. This marks another important achievement of the group in the field of assisted reproductive solutions, and is the 60th medical device registration certificate obtained by the group.

·Vitrification Warming Solution Kit – Registration No. Guoxiezhuzhun 20263181555

Product label information:

· Vitrification Warming Solution Kit

· Volume: 5 mL

· 3 vials per box

· Warming Solution (TS)

· Manufacturer: Suzhou Mednuorui Medical Technology Co., Ltd.

In vitro fertilization and embryo transfer (IVF-ET) is one of the assisted reproductive technologies for infertility treatment, bringing hope to infertile patients. Embryo vitrification and warming technology is a widely applied method in assisted reproduction. In this procedure, embryos are cryopreserved via vitrification under controlled conditions, and warmed when needed for embryo transfer.

The vitrification warming process is the reverse of the vitrification freezing process. The corresponding medical devices for the two procedures are the Vitrification Solution Kit and the Vitrification Warming Solution Kit.

·Mechanism of Action

The warming process involves the re-entry of water into cells and the elution and release of permeable cryoprotectants. The warming solution is formulated with a stepwise decreasing concentration of cryoprotectants, which alleviates transmembrane osmotic pressure changes during embryo warming and prevents osmotic shock.

Indications

This product is indicated for the warming of human oocytes, pronuclear-stage embryos, cleavage-stage embryos and blastocysts after vitrification.

· Oocytes (MⅡ stage): Suitable for the cryopreservation and warming of mature oocytes, providing key technical support for female fertility preservation.

· Pronuclear-stage embryos: Targeting the zygote stage 16–18 hours after fertilization, suitable for the cryopreservation and warming of early embryos.

· Cleavage-stage embryos: Covering the developmental stage on day 2–3 (4–8 cell stage).

· Blastocysts: Embryos developed on day 5–6, with a more stable structure and high warming survival rate, making them ideal candidates for vitrification.

The previously approved Vitrification Solution Kit (Registration No. Guoxiezhuzhun 20263180953) of the group is used for the freezing step, while the Vitrification Warming Solution Kit focuses on the warming step. The two products complement each other.

Core Function Comparison of Vitrification Kits

The two have opposite functions but share the same goal: to maximize the preservation of cell viability.

Component Design Logic Comparison

Component Logic of Vitrification Solution

· High-concentration permeable cryoprotectants (EG, DMSO): rapidly penetrate cells and replace water to prevent ice crystal formation.

· High-concentration non-permeable cryoprotectant (trehalose): maintains extracellular hyperosmotic pressure to prevent cell rupture caused by excessive rapid water influx.

· Core logic: high concentration, rapid action → pursuit of rapid vitrification

Component Logic of Vitrification Warming Solution

· Gradually decreasing concentrations of permeable cryoprotectants: gradient dilution strategy to minimize osmotic shock.

· High-concentration non-permeable cryoprotectant (trehalose): creates an extracellular hyperosmotic environment to assist ordered rehydration and stabilize cell membrane structure.

· Core logic: gradient dilution, gentle transition → pursuit of safe warming

Summary of Design Differences

· The vitrification solution emphasizes speed and solidification;

· The warming solution emphasizes stability and protection;

· The two complement each other to ensure cell viability.

Product Advantages

Trehalose replaces sucrose to inhibit ice crystal recrystallization risk Trehalose is used to replace traditional sucrose as the non-permeable cryoprotectant. It has a higher glass transition temperature (Tg'), which better maintains the glassy state during the warming process and significantly reduces the probability of ice crystal recrystallization. Trehalose also has stronger affinity for phospholipid membranes, supporting the ordered re-entry of water into cellsand reducing mechanical damage.

Designed as a matched set with the vitrification solution for seamless system compatibility The warming solution and the supporting vitrification solution adopt the same basic buffer system and protectant combination, ensuring a continuous and consistent chemical environment throughout the entire freezing-warming process.

Gradient-decreasing cryoprotectant concentration for precise prevention of osmotic shock The warming solution is formulated with a stepwise gradient of decreasing cryoprotectant concentration, enabling ordered release of intracellular high-concentration protectants and gradual water re-infiltration. This effectively mitigates drastic fluctuations in transmembrane osmotic pressure, prevents excessive cell swelling or shrinkage, and preserves the functions of the cytoskeleton and organelles.