

Theregen's primary corporate objective is the clinical development and approval of Anginera. Anginera initially will treat heart failure associated with ischemia. This heart failure is often caused by diffuse small vessel disease.
Anginera is an epicardial cell-based therapy similar to Dermagraft™, an FDA-approved wound management product. This heart therapy may require two or more Anginera patches applied directly to the surface of the heart (epicardium) during conventional bypass surgery. Preclinical studies suggest that Anginera promotes angiogenesis and arteriogenesis (small blood vessel development) when placed onto the surface of a damaged heart. Animal studies in heart failure also showed improved heart pumping function. 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 a source of the cytokines and growth factors needed to induce angiogenesis and tissue repair. The preclinical studies have also provided evidence that Anginera supports improved function in a chronic 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 conventional revascularization therapies (e.g., CABG and stents).