Bio-Knit Innovation Transforming Tissue Regeneration for Heart Valve Replacement

Over 12,500 people every year in the UK alone require heart valve replacements as the only effective form of treatment. Worldwide the figure is 300,000, with the total global heart valve market estimated to exceed £7bn by 2024, and increasing with an aging population. The replacement of a defective heart valve results in significant improvements in both the patient's survival and their quality of life. However, currently the available valve substitutes have significant drawbacks, due to the fact that they are not living tissues. Surgical complications include clotting and bleeding, structural failure, and limited durability. Furthermore, if the patient is a child, the existing valve replacements do not allow for growth of the valve, meaning multiple surgeries with added risks are required as the child grows.

The net result is that the existing valve replacements still do not match the longevity and quality of life of the general population. The only remedy for these problems is producing a "living" valve by tissue engineering, which is the purpose of this project.

Existing valve replacements are transplanted from human (limited) or porcine donors, which can also raise ethical and religious issues.

Our project would create a polymeric bioabsorbable scaffold which attracts and accommodates host cells from blood circulation. The scaffold's microstructure instructs the cells to lay down matrix (collagens, elastin and others) and develop into living tissue. Once suitably colonised with the patient's own tissue, the scaffold then dissolves, leaving the patient with a natural valve their own body has produced. This will grow with paediatric patients, and should ensure longevity and quality of life equivalent to the general population.

Being successful in this endeavour would ensure that UK and Germany remain world leaders in the frontier of the regenerative medical device industry, and provide a long-term sustainable addition to UK and German revenue and the overall economy.

This project aims to produce a unique, acellular, off-the-shelf valve which will rapidly remodel into a living valve in the patient. This breakthrough technology will improve the patients' life expectancy and quality of life, which will therefore make it a more affordable solution to the healthcare systems than the medical device industry can currently provide. Upon regulatory approval, it will address the worldwide existing unmet need.