The Problem

​Congenital Heart Defects (CHD) affect 1 in 100 births world-wide, with ~40,000 new cases every year in the USA.

These birth defects are usually the result of inadequate heart muscle development, leaving the child with a suboptimal heart that requires lifelong surgical treatments and medical management. 

There are currently no effective long-term treatments for the most severe and rare forms of CHD- new products are needed. Academic research is not focused on product development and biotechnology industry is unable to justify the investment in such a small market. Thus, current standard of care, in even the most successful medical institutions, remain stuck in a palliative rather than curative mindset.    

Our Solution

​We plan to build heart muscle that will be tested in many different shapes and sizes of CHD with a single purpose to repair the defect- thus providing a curative approach for CHD. We build hearts.

Hearts born with a “manufacturing defect” need to be biologically rebuilt, not just surgically repaired as we have been doing for decades.

Current technology with stem cells and regenerative medicine provides a pathway forward to bioengineer new heart muscle that is genetically identical to the individual with a congenital heart defect- thus eliminating the need for immunosuppression drugs.

About the HLHS Consortium

The Todd and Karen Wanek Family Program for HLHS at Mayo Clinic created the HLHS Consortium and HeartWorks to improve access to clinical trials and allow researchers to pool scientific knowledge with top cardiovascular programs around the country. The consortium helps decrease the amount of time from research and discovery to the clinical application of innovative cell-based therapies.​ The HLHS Consortium has regional centers across the U.S. to fund the development of cell-based, innovative research opportunities that can transform the lives of people living with HLHS and CHD (Congenital heart disease).

This national network aligns and regional centers to accelerate the completion of clinical trials and develop a financial model to sustain a continuous pace of HLHS and CHD research and innovation.

About HeartWorks

HeartWorks was created in June 2020 to advance the product development pioneered by the Todd and Karen Wanek Family Program for Hypoplastic Left Heart Syndrome (HLHS), founded at Mayo Clinic in 2010.

HeartWorks is laser focused on CHD research and creating positive outcomes for people born with congenital heart defects. Through our revolutionary platform, we tap the best ideas and advance them through trials and onto therapies that give children and adults with CHD an opportunity to live fulfilling lives.

What is HLHS?

Hypoplastic left heart syndrome (HLHS) is a birth defect that affects normal blood flow through the heart. As the baby develops during pregnancy, the left side of the heart does not form correctly. Hypoplastic left heart syndrome is one type of congenital heart defect. Congenital means present at birth.

What is CHD?

Congenital heart disease (CHD) is one or more problems with the heart's structure that exist since birth. Congenital means that you're born with the defect. Congenital heart disease, also called congenital heart defect, can change the way blood flows through your heart. Some congenital heart defects might not cause any problems. Complex defects, however, can cause life-threatening complications


HLHS Consortium Partners