Who We Are
Who We Are
We build, test, and deliver new therapies to cure congenital heart defects, allowing families to live full, enriching lives.
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Our Work
Our Work
HeartWorks builds, tests, and delivers new therapies to cure congenital heart defects giving these families the opportunity to live full, enriching lives.
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For Families
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HeartWorks relies on our community to help fund the research and clinical trials that hope to find cures for congenital heart defects (CHD). Discover ways that you can help.
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Clinical Trials
Clinical Trials
Learn about upcoming, ongoing, and previous CHD clinical trials being done with our consortium partners.
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The Co-op
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We Build Hearts

HeartWorks has created a first-of-its-kind clinical platform to treat more patients and create more therapies.

Our Goal

Treating children & adults with CHD using novel stem cell therapies that delay the need for
a heart transplant forever.

HeartWorks has designed a first-of-its-kind platform that brings together physicians, 
scientists, and engineers to find and develop treatments for the most severe forms 
of congenital heart defects (CHD) to further advance research in genetics, stem cell biology, clinical trials, and cell-based manufacturing.

We get treatments out of the lab and into clinical trials to be conducted simultaneously in collaboration with a consortium of world-class medical institutions. Our vision is that our therapies will become a cure so children and adults born with CHD will no longer
have to live with CHD. Below are our revolutionary products.

our products

Bioengineered Cardiac Tissue

Bioengineered Cardiac Tissue produces contracting heart muscle cells that are genetically identical to the patient’s own body; a “seed” that can be planted in a failing heart to help rebuild the weak muscle.

Visit Clinical Trial Page

CardiaCord

CardiaCord is an autologous (self) cell-based product derived from the umbilical cord that has been shown in pre-clinical settings to stimulate native heart muscle cells to grow faster, stronger and larger.

Visit Clinical Trial Page

The Co-Op at HeartWorks

We are on a mission to create the world’s largest database of CHD patients. This will help us design clinical trials for the current CHD population and allow us to connect members of the co-op with clinical trial opportunities. 

Become A Member

what we are working on today

At HeartWorks, critical advances in medicine start with foundational research, paving the way for innovative and effective therapies. Our Research and Development (R&D) team is at the forefront of this journey, driving our efforts to enhance and refine our bioengineered cell therapies.

A central focus of our R&D team is the in-depth characterization of cells used in our cardiomyocyte-based therapies. We begin with patient skin cells, which are converted into induced pluripotent stem cells (iPSCs). These iPSCs are then selectively differentiated into functional cardiomyocytes, or heart muscle cells. This process is intricate and involves creating bioengineered cell products that include various sub-types of cardiomyocytes.

Our R&D team has developed advanced methods to analyze these cell sub-types, gaining insights into their molecular characteristics and clinical potential. In 2023, we introduced two key approaches to advance this work:

  • Gene Sequencing: We analyze which genes are activated or deactivated during the conversion and differentiation processes, providing a detailed understanding of gene expression in our cell preparations.
  • Electrical Properties Analysis: We measure the electrical properties of cardiomyocytes, which are crucial for understanding how these cells contribute to heart function in patients.

The ultimate goal of our genetic and electrical studies is to develop patient-specific cardiomyocyte preparations that optimize heart muscle function and enhance therapeutic outcomes. Through these advancements, HeartWorks is committed to pushing the boundaries of medical research and delivering cutting-edge solutions to improve patient care.

HeartWorks innovative bioengineered cell therapies rely heavily on our exceptional manufacturing team. This team is essential in executing the intricate, multi-step processes required to transform patient skin cells into induced pluripotent stem cells (iPSCs), expand these stem cells, and then differentiate them into functional cardiomyocytes (heart muscle cells) for our therapies.

Our manufacturing processes have evolved continuously, with the development of robust, FDA-approved procedures crucial for our clinical trials. The achievements of our manufacturing team in 2023 reflect substantial progress, as demonstrated by the dramatic increase in cardiomyocyte yield:

2015

2017

2019

2023

future

     

100K

4M

300M

3B

++

 

This impressive scaling of production capacity highlights the innovation, productivity, and quality of our manufacturing operations. In 2023, our team enhanced batch sizes by increasing the number of vessels used for each sample, proving to be more effective than altering vessel sizes or designs. Additionally, we optimized productivity through refined synchronization of manufacturing activities.

Looking ahead, as patient numbers and clinical trials increase, we plan to incorporate bioreactors. These advanced systems will provide optimized conditions for producing cardiomyocytes, further advancing our ability to meet growing demand and continue delivering groundbreaking therapies.

Our manufacturing team’s dedication is a cornerstone of HeartWorks’ success, enabling us to push the boundaries of medical research and provide cutting-edge treatments to patients.

Our Co-Op program addresses key challenges in managing patient records by providing a centralized, patient-controlled database. This system securely aggregates medical records from all providers, if the patients choose, making it easier for CHD patients and their families to access and manage their health information for their care and for use by HeartWorks and potentially other researchers.

    • Empowering Patients and Enhancing Research: The Co-Op empowers patients by simplifying access to their complete medical history and facilitating its sharing with any chosen medical providers. For researchers and clinicians, it provides crucial data to design better clinical trials and develop targeted therapies.
    • A Valuable Resource: In addition to patient records, the Co-Op also contains information on ongoing protocols and previous research, supporting our continuous efforts to improve CHD care and advance research. In addition to patient records, the Co-Op will expand its patient resource content to include information on ongoing protocols and previous research, supporting our continuous efforts to improve CHD care and advance research.

The Co-Op will be a major contributor to the heart community and to HeartWorks transforming patient care for CHD patients and their families.

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