Development of a High-Hydrostatic Pressure Device for Pigmented Nevus Tissue Inactivation and Dermal Regeneration

The high-hydrostatic pressure device uses high pressure to destroy all cells in tissue while preserving its structure. The target disease is congenital giant pigmented nevus，a benign skin tumor. We have begun investigating a new treatment method that involves killing all cells contained in the excised nevus and then regenerating the dermis through reimplantation. After confirming its efficacy in preclinical trials and conducting a first-in-human clinical trial，we initiated a physician-initiated clinical trial aimed at obtaining medical device approval. This trial confirmed that skin regeneration is possible using pressurized nevi and cultured epidermis. Currently, we are conducting basic research to apply this device to inactivate malignant bone tumors and facilitate reimplantation.