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.
The purpose of this study is to Generate autologous iPSC in a manner compliant with requirements for future clinical use and reduce manufacturing time when patients are identified as eligible to receive product discussed in Bioengineered Cardiac Tissue Trial.
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.
This study aims to create a database of members medical journey data to inform future clinical innovation and design of clinical trials which address the needs of the members.
The knowledge generated from this study will help advance the care of CHD patients.
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:
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.
The Co-op will be a major contributor to the heart community and to HeartWorks transforming patient care for CHD patients and their families.
Become a member of The Co-op here.
HeartWorks and Mayo Clinic launch a clinical trial that involves surgically injecting lab-grown cardiac tissue—sourced from the patients’ skin cells—in people with congenital heart disease.
At HeartWorks, our mission is centered on building stronger hearts and more memories for individuals and families affected by congenital heart defects. Recently, we had the privilege of being the
At HeartWorks, our mission is driven by the relentless pursuit of advancing treatments and finding a cure for Congenital Heart Defects (CHD). Every initiative we undertake, every event we organize,
We are thrilled to share the success of the third annual Callie’s Giving Heart Foundation Pool Party, which took place on Saturday, July 27, 2024, at the Versailles Community Pool
“I’m confident that in the decade ahead, we will be able to rebuild hearts and cure congenital heart disease with this technology. It is laborious work but a labor of
Ashley is proud to partner with HeartWorks through the support of Ashley’s President and CEO, Todd Wanek and his wife Karen. Their philanthropic contributions have helped accelerate the expansion of