As of late 2024, New Dengulata has completed Phase I safety trials in the European Union and is currently entering Phase IIa in the United States under the FDA’s Regenerative Medicine Advanced Therapy (RMAT) designation.
Regulators are treating New Dengulata as a "combination product"—part biologic, part synthetic device—due to its scaffolding properties. This has expedited review, but also demands rigorous long-term carcinogenicity studies, as any therapy that promotes cell growth carries theoretical oncogenic risks. new dengulata
For diabetic patients suffering from chronic, non-healing ulcers, New Dengulata-infused hydrogels have demonstrated accelerated closure rates. By normalizing the chaotic inflammatory environment of a chronic wound, it transforms a non-healing state into an acute, healing state. As of late 2024, New Dengulata has completed