Development of a bioengineered basement membrane to enhance the performance of blood-contacting devices

Each year, over 10 million of transitory and permanent blood-contacting devices are implanted worldwide, playing a crucial role in addressing cardiovascular diseases and providing life-sustaining support. However, despite their widespread use, sub-optimal biocompatibility still represents a major challenge, compromising safety, efficacy, and durability. Up to 70% of patients experience device-related hemocompatibility issues, significantly affecting their quality of life. To mitigate these risks, antithrombotic drugs are commonly prescribed, yet these systemic treatments come with severe complications, including postoperative bleeding, stroke, and hemorrhage. To address these limitations, material surface modification strategies have been explored to improve the hemocompatibility of blood-contacting devices, with a particular emphasis on promoting stable endothelialization. Among these approaches, physical modifications, such as surface patterning, are considered superior to biological and chemical functionalization because they offer a long-lasting performance, without degrading or losing functionality over time, unlike conventional surface coatings. Despite the continued interest from both industrial and academic research, there are no clinically available bioengineered substrates that integrate mesoscale and microscale surface features able to promote and maintain stable device endothelialization that can ensure long-term resistance to thrombus formation. In this proposal, we aim to optimize and validate HemoStratum, a bioengineered substrate fabricated by our proprietary processing technology. By integrating electrodeposition and photolithography, HemoStratum leverages on both microfibers and meso-patterns identified to promote endothelial cell proliferation and structural organization. This notion represents a radical innovation that can enhance hemocompatibility of a broad spectrum of blood-contacting devices while ensuring long-term stability, and durability.