The First Beat of a Cure Begins Here

For decades, the story of congenital heart disease has been one of survival. Surgeries reconstruct tiny hearts. Procedures extend lives. Medications manage what surgery cannot fix. For families navigating this diagnosis, those advances have meant everything:  more birthdays, more milestones, more time.

But survival is not a cure. And for the children and adults living with congenital heart disease (CHD), the work of healing is never finished.

HeartWorks was built to change that. And right now, we are closer than we have ever been.

What Current Treatment Can and Cannot Do

Today, children born with CHD often face a lifetime of intervention: multiple open-heart surgeries, progressive heart failure, declining cardiac function, and limited options as they grow older. For many, transplantation becomes the final path forward.

Current treatment helps patients survive. It does not restore the heart itself.

That distinction, between repair and restoration, is at the center of everything HeartWorks is working toward.

A New Kind of Medicine: The Your Heart Program

The Your Heart Program is built on a question that once belonged only to science fiction: what if damaged heart tissue could be rebuilt using the patient’s own cells?

The process begins with something deceptively simple: a small skin biopsy. From that single sample, scientists isolate fibroblast cells and reprogram them into induced pluripotent stem cells (iPSCs) — cells capable of becoming virtually any tissue in the human body. Those stem cells are then carefully guided through multiple stages of development until they become living, beating cardiac cells.

Those cardiac cells are then prepared for reintroduction into the patient’s heart, with the goal of strengthening damaged muscle tissue and improving how the heart functions.

This is personalized, autologous therapy. Created from the patient, for the patient. No donor match required. No foreign tissue. Just the patient’s own biology, redirected toward healing.

“From temporary repair to biological restoration. From managing disease to rebuilding function. From extending survival to creating the possibility of long-term healing.”

Why This Takes Time and Why That Matters

Transforming a skin biopsy into viable human cardiac tissue is one of the most sophisticated processes in modern medicine. While collecting the biopsy takes only minutes, creating treatment-ready heart cells requires approximately nine months of highly controlled laboratory development for each individual patient.

During that process, cells must be safely reprogrammed, carefully guided through developmental stages that mirror how the human heart naturally forms, repeatedly tested for genetic stability and purity, and allowed to mature into authentic cardiac tissue before they are ever considered for human treatment.

This cannot be mass produced. Every therapy is individually developed for a specific patient. Every stage requires precision. Every milestone requires validation.

The science cannot be rushed  because the patients cannot afford uncertainty.

Where We Are Right Now

HeartWorks has received the world’s first FDA approval to move this therapy toward human application in congenital heart disease. That milestone alone marks a turning point in the history of this field. But we haven’t stopped there. We have already:

– Enrolled 100 adult congenital heart disease patients

– Collected skin biopsies from each participant

-Advanced patient cells through manufacturing

-Demonstrated promising preclinical outcomes

Now, for the first time, we are approaching human treatment.

The patients in our current cohort often have limited options remaining. Many are no longer candidates for additional surgery and may never qualify for transplantation. For them, regenerative therapy may represent the first truly new treatment pathway in decades.

The Campaign: $3.7 Million to Treat the First Patients

HeartWorks is seeking $3.7 million in philanthropic investment to complete the first phase of the Study Ready Cohort and move regenerative cardiac therapy into human application.

To date, $1.8 million has already been secured and will be fully deployed by September 2026 to support biopsy collection, stem cell development for 25 patients, and cardiac cell production for the first 3 treatment-ready patients. The additional $3.7 million will carry us through to the completion of this critical phase.

By the end of 2028, our goal is for all 100 enrolled patients to have personalized cardiac stem cell lines established and for 10 adult CHD patients to have received regenerative cardiac cell therapy.

At the center of this effort is a clear measure of impact: $100,000 funds one patient’s complete, personalized heart cell therapy. Every dollar of that goes directly toward creating that patient’s treatment – because our annual operational costs are already covered.

Meaningful participation is possible at every level:

-$100,000 funds one complete patient therapy

-$50,000 supports 50% of a patient treatment

-$25,000 supports 25% of a patient treatment

Every contribution advances the same goal: moving regenerative heart therapy from the laboratory into the lives of patients.

What Success Makes Possible

The Your Heart Program begins with adults because they face the most immediate need and can help establish clinical feasibility. But the ultimate vision reaches far beyond this first patient population.

Success in adults creates the pathway toward earlier intervention, pediatric treatment applications, and improved lifelong outcomes for children born with congenital heart disease. Most importantly, it creates the possibility that future children may someday grow up without facing a lifetime of surgeries and decline.

That is the vision HeartWorks was built to pursue. And we are closer to it now than at any point in history.

“There are rare moments in medicine when years of research, innovation, and urgency converge into a single opportunity to change what is possible. This is one of those moments.”

Be Part of This Moment

The science is ready. The patients are waiting. Now, philanthropy must help carry this breakthrough across the finish line.

To learn more about the Your Heart Program or discuss a giving plan, contact Kimera Way directly at kimera@webuildhearts.org. 

The first beat of a cure begins here.