Theregen's primary corporate objective is the clinical development and approval of Anginera. Anginera initially will be used to treat patients with Ischemic Heart Disease manifesting as refractory angina.
Anginera is an epicardial cell-based therapy similar to Dermagraft™, an FDA-approved wound management product. Anginera patches are applied directly to the surface of the heart (epicardium) during surgery. Preclinical and clinical studies suggest that Anginera promotes arteriogenesis (mature blood vessel development) when placed onto the surface of a damaged heart. Anginera's technology platform uses human fibroblast cells cultured and grown on a three-dimensional bioabsorbable scaffold material to create a viable tissue. When applied as an epicardial patch to an ischemic area of the heart, the living tissue provides more than 20 cytokines and growth factors needed to induce arteriogenesis and tissue repair. Preclinical studies provide evidence that Anginera supports improved function in a chronically ischemic heart model. A major benefit of Anginera treatment may be the improvement of blood flow to areas of the heart that are not treatable by standard surgical or pharmaceutical treatments (e.g., CABG, PCI, optimal medical therapy).