Vascudyne, Inc. products

Synthetic vascular grafts currently used in clinic have poor long term outcomes and low patency rates. Hyperplasia, calcification, foreign body immune response, infection, and atheroma formation are commonly encountered limiting the use of synthetic grafts, with none available for small diameter applications like coronary bypass.

Bioprosthetic heart valves may have addressed some of the limitations of mechanical valves but still carry their own: gradual degeneration such as pannus growth, leaflet fibrosis and calcification, delamination of the connective tissue, and emergence of ruptures and perforations all eventually lead to valve failure (Kostyunin et al, 2020). While structural valve degeneration is under ongoing investigation, long term immune rejection and atherosclerosis-like tissue remodeling are emerging as potential causes. TRUE Heart Valve has been specifically designed to address these limitations. Non-calcific, non-immunogenic, 100% biological without any synthetic raw materials, and with tunable mechanical properties that mimic native valve performance, TRUE Heart Valve has been shown to support somatic growth in animal models as published in peer-reviewed publications.

Our proprietary TRUE Tissue technology platform is currently available for investigational use only. TRUE Tissue developed from cells isolated from donor tissue and is 100% biological. There are no synthetic materials or chemical fixation used, and implanted tissues are completely cell-derived and acellular. That’s how we make tissues that are TRUE to Nature.

Tissue patches are routinely used in surgery for soft tissue repair and reconstruction throughout the body in cardiovascular, orthopedic, abdominal and thoracic wall applications. Current therapies are predominantly xenogeneic, allogeneic or synthetic biomaterials such as bovine pericardium, ePTFE, small intestinal submucosa, and dermal grafts. However, issues persist: incomplete tissue remodeling, mechanical mismatch, and reduced vascularity.