Congenital heart disease (CHD) is caused by defects in the heart structure that occur at birth and affect bloodflow through the heart and the rest of the body. CHD affects around 10 out of 1,000 live-born children, 25% ofwhich will need an intervention or surgery within their first year of life. Circa 1 million children and 1.4 millionadults live with CHD in the US, and over 182,000 heart valve replacements are performed every year. Currently,available heart valve prostheses do not perform as native cardiac tissue and have several limitations related totheir durability and ability to support tissue regeneration. In addition, they have been associated withcomplications such as clots, increased risk of thrombosis and thromboembolism, calcification, and infection.Replacement of bioprosthetic valves often requires complex and high-risk operations and poses an economicburden of $1.7B in the US per year to the healthcare system.Neoolife aims to overcome these major drawbacks in CHD therapy by developing tissue engineered heartvalves (TEHVs) that are fabricated using scaffolds that mimic human tissue. Through endogenous tissue growth,Neoolife's biomimetic pulmonary heart valves are extensively augmented or eventually replaced, leavingautologous and functional leaflets that grow with the CHD pediatric patient that are durable and non-thrombogenic. These biomimetic valves do not require life-long blood thinner treatments and are resistant tocalcification and infection. In this STTR Phase I project, Neoolife will modify its proprietary Double ComponentDeposition (DCD) technology to obtain a more homogeneous biomimetic scaffold deposition. Biomimeticpulmonary heart valve prototypes (n=10) will be fabricated using a new multiple stage processing setup. Theprototypes will be tested in vitro for their mechanical and functional properties and assessed in vivo (n=5, 180days) to evaluate polymer degradation, cellularization, biomechanics, and valve function.In Phase II, further in vitro and in vivo studies will be performed to provide sufficient technical information todemonstrate that Neoolife developed pulmonary heart valve qualifies for obtaining a Humanitarian DeviceExemption (HDE) designation for the treatment of pediatric CHD.
Public Health Relevance Statement: PROJECT NARRATIVE
Congenital heart disease (CHD) is the most frequent birth defect that comes with a high risk of requiring life-
saving surgery within the first year of the newborn's life. The most common procedure for CHD is pulmonary
heart valve replacement, but current valve solutions are inadequate with over 20% of cases needing reoperations
within 5 to 15 years of implant. This STTR project will address the limitations of current bioprosthetic valves by
developing a biomimetic pulmonary heart valve that successfully mimics human tissue, which will increase the
quality of life and decrease the risk of reoperations for pediatric CHD patients.
Project Terms: <21+ years old><0-11 years old><0-4 weeks old> | 