Enterprise News |Yicheng Bio's New Class II/III Medical Devices Approved, Leading Innovation in Medical Aesthetic Equipment

2025-02-13

Over the past year, Yicheng Bio and its subsidiaries have achieved groundbreaking progress in multiple self-developed products. The companys silk fibroin liquid dressing and PPDO knot-free absorbable surgical suture have successively obtained Class II and Class III medical device registrations and production licenses. This milestone marks Yicheng Bios transition from the R&D phase to the commercialization stage. Moving forward, the company will further invest in delivering high-quality medical devices to the market, driving high-quality development in the medical aesthetics industry.

Silk fibroin, a natural protein extracted from silkworms, shares homology with human epidermal protein and can be directly absorbed by the body. Its unique properties make it ideal for tissue repair and regenerative medicine:

Biocompatibility: Minimizes immune response while enhancing cellular activity to promote tissue regeneration.

Permeable Structure: Facilitates oxygen and nutrient transport, maintaining cellular interactions.

Active Functional Sites: Accelerates re-epithelialization, wound closure, angiogenesis, and healing.


The newly approved "Mengyuwei" silk fibroin liquid dressing is sterile, with endotoxin levels <0.5 EU/g, making it suitable for post-treatment skin care (e.g., laser therapy, chemical peels, and minimally invasive procedures).

This PPDO-based suture addresses hydrolysis and tension loss challenges through advanced engineering:

Low Moisture Content: Special processing ensures moisture levels remain far below national standards during shelf life, ensuring PDO stability at room temperature.High Tensile Strength: Animal studies show sutured tissues regain original tension strength within 2128 days.

Innovative Design:

3D 360° spiral serration structure with a 25° cutting angle maximizes geometric stiffness.

812 serrations provide secure anchoring; single-needle design aligns with surgical habits.

Imported PDO material offers optimal softness, simplifying procedures and improving outcomes.

After 7 years of development, Yicheng Bios PCL absorbable injectable microspheres have completed clinical trials, demonstrating superior performance compared to leading benchmarks. This product is poised to revolutionize the medical aesthetics regenerative market.

Yicheng Bio has invested tens of millions to establish three core technology platforms: polyester microspheres, silk fibroin, and decellularized matrix. The company has also filed master documents for "Medical Polycaprolactone (PCL) Microspheres" and "Medical Soluble Silk Fibroin Raw Materials", accelerating the cost-effective commercialization of biomedical devices.

With innovation at its core, Yicheng Bio continues to pioneer advancements in medical aesthetics, empowering a new era of safe, effective, and accessible solutions.

 


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