One Step Closer: HeartWorks Partners with SmartCella to Advance Cardiac Cell Delivery
At HeartWorks, we’re working to develop personalized cardiac cell therapies using a patient’s own cells, with the goal of strengthening weakened heart muscle and creating new treatment options for people living with congenital heart disease (CHD). Over the past several years, our team has made significant progress in collecting patient skin samples, manufacturing cardiac cells, and advancing the science behind these potential therapies. But even though we can successfully manufacture beating heart cells in the lab, our original method of cell delivery involved a major surgical procedure. We’ve worked hard to identify a less invasive manner for cell administration to reduce risk to the patient. Today, HeartWorks took an exciting step toward that milestone.
Introducing Our Partnership with SmartCella
HeartWorks has entered into a licensing agreement with SmartCella, a Sweden-based drug delivery company, to use its innovative Extroducer® delivery platform in our clinical trials. The Extroducer is a minimally invasive, catheter-based technology designed to deliver therapeutic agents directly to targeted tissues using the body’s blood vessels as access routes. Developed from research at Sweden’s Karolinska Institutet, the technology offers a potential approach to reaching heart muscle without the need for open-heart surgery.
For HeartWorks, this partnership brings together two important pieces of the puzzle: our personalized cardiac cell therapies and a delivery technology that reduces risk to the patient during cell delivery.
“For patients with the most severe forms of congenital heart disease, the challenge has never been developing promising cell therapies alone. It has been delivering them safely and precisely into the heart. The Extroducer’s ability to reach the myocardium through the vasculature, without open-heart surgery, is exactly the kind of innovation we need to bring autologous cardiac cell therapies to more patients.”
— Dr. Tim Nelson, CEO and Co-Founder of HeartWorks
Why This Matters for People Living with CHD
For individuals born with complex congenital heart defects — particularly those living with single-ventricle conditions such as hypoplastic left heart syndrome (HLHS) — a series of surgeries can help manage blood flow and improve survival. However, these procedures do not replace or regenerate weakened heart muscle. HeartWorks is working to change that by developing therapies designed to strengthen the heart using cells created from a patient’s own skin sample.
A minimally invasive delivery approach could be especially meaningful for individuals who have already undergone multiple heart surgeries. Rather than requiring another open-heart procedure to deliver a potential therapy. The Extroducer platform has FDA 510(k) clearance for certain peripheral tissue applications, but its use for delivering HeartWorks’ cardiac cells to the heart requires additional development and evaluation.
Putting Our Cells to the Test
Before committing to a delivery device, our team needed to assess the impact of passing cells through a long, narrow catheter would damage the cells. The HeartWorks and Smartcella teams partnered to conduct laboratory testing to evaluate how our cardiac lineage cells responded to different delivery conditions. The results were encouraging, our cells maintained high viability and integrity across the flow conditions tested, demonstrating their resilience during the delivery process. This data will be central to obtaining FDA authorization to incorporate this delivery device into our clinical studies.
Moving Closer to Patients
In 2026, HeartWorks celebrated reaching our first 100 participants in the Skin Punch Biopsy Sample Collection Study. Each participant has helped establish the foundation for manufacturing personalized cardiac cells, bringing us closer to our goal of developing treatments for those living with CHD. Now, with continued progress in manufacturing and a delivery technology identified, we’re advancing another critical piece of the process.
Our partnership with SmartCella reflects something we believe strongly at HeartWorks: meaningful innovation happens through collaboration. By working with organizations that bring different technologies and expertise to the table, we can move promising discoveries forward more efficiently and focus on what matters most — creating new treatment options for patients.
There’s still important work ahead, including additional testing, clinical development, and regulatory evaluation. But each milestone brings us closer to the day when personalized cardiac cell therapies could become an option for children and adults living with congenital heart disease.
We’re not just working to build beating heart cells. We’re working to get them where they’re needed most.
