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Drug intelligence / Profile preview
Sanoplast Duo
- Development stage
- Unknown
- Lead developer
- BioXtek
- Administration
- Topical
01
Overview
Sanoplast Duo is a sterile, dual-layer (with tri-layer and quad-layer configurations available) dehydrated amniotic membrane allograft developed by BioXtek. It is derived from human placental tissue and processed to preserve the native extracellular matrix (ECM) structure while removing cellular components to minimize inflammatory risk. Sanoplast Duo is designed to serve as a protective wound covering and biological scaffold, supporting tissue regeneration and wound healing in applications such as diabetic foot ulcers, burns, and other complex wounds. Although commercialized as an HCT/P (Human Cells, Tissues, and Cellular and Tissue-Based Product) under Section 361 of the PHS Act, the FDA issued a warning letter to BioXtek in late 2025, classifying Sanoplast Duo as an unapproved new drug and unlicensed biological product due to therapeutic marketing claims that exceed homologous use.
- Brand names
- Sanoplast Duo
- Other names
- Multi-layer amniotic membrane allograftQuad-layer amnion-chorion allograftTri-layer amnion-chorion allograft
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