Pt 2: Why HeartWorks Exists: Building a Better Way to Develop CHD Therapies

A New Model for CHD Innovation

Developing a new medical therapy takes far more than a scientific discovery.

It requires researchers, manufacturing experts, regulatory specialists, clinicians, engineers, and patients working together through every stage of development. For congenital heart disease, that challenge becomes even greater because there has never been a simple solution.

As HeartWorks founder Dr. Tim Nelson advanced groundbreaking work in regenerative medicine, one thing became increasingly clear: bringing these therapies to patients would require more than a traditional academic research program.

It would require an entirely new platform.

That realization led to the creation of HeartWorks, a nonprofit organization built specifically to accelerate innovation for congenital heart disease.

Today, HeartWorks brings together research and discovery, GMP manufacturing, preclinical testing, clinical operations, patient engagement, and data science under one mission: advancing therapies for congenital heart disease.

Instead of operating as independent pieces, these teams work together every day, helping move ideas from the laboratory toward patients more efficiently than traditional models often allow.

This integrated approach allows HeartWorks to focus on what matters most: developing new therapies, preparing them for clinical use, and ensuring every step is centered around the needs of patients and families.

HeartWorks wasn’t created simply to do research.

It was created to build the future of congenital heart disease care.

This article is Part 2 of our HeartWorks 101 educational series. Next, discover how a small skin biopsy can become bioengineered heart muscle cells through regenerative medicine.

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