Huanuo Bio's Implant-Grade "Gelatin Submicron Particles" Receives Medical Device Master File Registration Approval

Recently, HUANOVA announced that its biomedical material product, “Gelatin Submicron Particles,” has successfully completed the filing for registration in the Master File of Medical Devices with the National Medical Products Administration.(Registration No. M2022052-000)。

The Medical Device Master File is a filing mechanism for research data on raw materials used in medical devices, issued by the National Medical Products Administration. It signifies that the owner of the Master File may authorize applicants for medical device registration to reference it as part of their regulatory submission materials during processes such as medical device registration applications.

HUANOVA'sThe successful filing of the “gelatin submicron particles” biomedical raw material product indicates that this product manufactured by HUANOVA can serve as one of the standard raw materials for the design and development of other domestic medical device products,When using HUANOVA’s “gelatin submicron particles” as a raw material, the research content on this product in the master file can be directly referenced. This facilitates the selection of raw materials and key components by medical device manufacturers, avoids duplicate submission of materials in medical device registration applications, and improves review efficiency.

Preliminary studies by HUANOVA’s R&D team have fully demonstrated that “gelatin submicron particles” throughReversible Self-Assembly Design, withExcellent InjectabilityandMoldabilitygel materials that can be widely applied in various biomedical scenarios, including wound repair, hemostatic filling, medical aesthetic fillers, and drug and stem cell delivery.

“Design Principles of Gel Materials Assembled from Gelatin Submicron Particles”

In surgical hemostasis scenarios, HUANOVA has developed Class III medical consumables based on the "gelatin submicron particles" biomedical materialHemostatic Gel and Hemostatic Powder Have Been Used in Hundreds of Clinical Surgical Cases, this isChina’s First Domestically Produced Hemostatic Gel Consumable for Minimally Invasive Applications, featuring excellent injectability and moldability, fully biodegradable and absorbable in vivo, with a broad range of clinical applications. It can perfectly adhere to bleeding wounds to achieve hemostasis, and its safety and efficacy have been fully demonstrated in clinical practice.

More importantly, as a platform-type medical raw material, "gelatin submicron particles" can be used for filling and hemostasis in various types of wounds, perfectly adapting to irregularly shaped wound sites. For example, they meet the needs for hemostasis and filling in tooth extraction sockets. Due to the high specific surface area of the submicron particles, this gel material can extensively adsorb components of blood clots around the wound site and gradually release them as the material degrades, thereby accelerating wound healing after hemostasis is achieved.

HUANOVA's Hemostatic Gel Product Based on "Gelatin Submicron Particles" for Clinical Spinal Surgery

Furthermore, "gelatin submicron particles" can also serve as delivery vehicles for bioactive protein drugs and live cells. They hold broad prospects in biomedical applications, such as preserving the biological activity of protein therapeutics and preventing immune clearance of allogeneic cells, thereby supporting the protein drug and cell therapy industries. In particular, with the accelerated development of the biopharmaceutical industry, many protein drugs are administered via intravenous injection, resulting in half-lives of only a few hours. This necessitates higher dosages, which increases treatment costs. HUANOVA’s gel-based carriers exhibit excellent sustained-release capabilities for both protein therapeutics and chemical drugs.Preliminary research data from the R&D team indicate that the sustained-release period for protein therapeutics can extend to several weeks, significantly enhancing therapeutic efficacy and reducing treatment costs.

“Gelatin Submicron Particles” for the Sustained Release of Protein-Based Therapeutics and Small-Molecule Antibiotics

“Gelatin Submicron Particles” Gel for Sustained Release of Growth Factors: Efficacy in Animal Experiments on Bone Defect Repair

AdditionallyIn cell delivery applications, this gel serves as a carrier material for stem cells and extracellular vesicles (exosomes), exhibiting excellent biocompatibility and the ability to promote cell adhesion and proliferation.Upon implantation, it provides a homing effect for stem cells and offers immune shielding for allogeneic stem cell engraftment, significantly extending the in vivo retention period of the stem cells. Animal studies have validated its efficacy in promoting regeneration of the cartilaginous region of the intervertebral nucleus pulposus in degenerative disc disease when used as a stem cell carrier.

“Gelatin Submicron Particle” Gel Blended with Stem Cell Suspension for Stem Cell Delivery in the Repair of Nucleus Pulposus and Cartilage Tissues of Intervertebral Discs

In medical aesthetic filler applications, this gel can be used in combination with bioactive substances. It offers excellent injectability and moldability, and can be combined with active agents such as analgesics, platelet-rich fibrin (PRF), live cells, and exosomes. Compared to traditional hyaluronic acid products, it provides significant advantages in promoting tissue regeneration.

In summary, the successful filing of the master file for HUANOVA’s “gelatin submicron particles” material provides a novel solution for clinical applications in regenerative medicine and opens up new avenues for the downstream application of next-generation biomaterials.