Drug intelligence / Profile preview

Regentys Extra-Cellular Matrix Hydrogel

Development stage
Preclinical
Lead developer
Generex Biotechnology
Modality
Tissue Cells → Other Cell Types → Cell Therapies, Hydrogel Systems → Drug Delivery Systems, Stem Cell Therapies → Cell Therapies
Administration
Rectal
01

Overview

Regentys Extra-Cellular Matrix Hydrogel (ECMH) is a first-in-class, non-pharmacologic regenerative medicine therapy developed by Regentys Corporation (formerly Asana Medical) for the treatment of Ulcerative Colitis and other inflammatory bowel diseases. The product consists of a proprietary, porcine-derived small intestine submucosa (SIS) extracellular matrix (ECM). Administered rectally as a powder reconstituted with saline, it gels at body temperature to form a "liquid bio-bandage" that coats the mucosal lining of the gastrointestinal tract. Unlike traditional immunosuppressive therapies, ECMH functions as a bio-scaffold that protects damaged tissue from fecal waste and provides a structural framework to recruit endogenous stem cells, thereby promoting natural tissue healing and regeneration. The FDA has indicated that the product can be approved through the Office of Device Evaluation via a 510(k) de novo application.

Brand names
Regentys Extra-Cellular Matrix Hydrogel
Other names
porcine-derived small intestine submucosa extracellular matrixSIS-ECMliquid bio-bandagebio-scaffold bandage

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