SmartCella Licenses Extroducer Endovascular Delivery Platform to HeartWorks for iPSC-Derived Cardiac Cell Therapies
HeartWorks is developing autologous iPSC-derived cardiac cell therapies for congenital heart disease and sponsors the only active clinical study of such cells for this indication.
Key Points
- SmartCella has signed a non-exclusive license agreement giving HeartWorks rights to use the Extroducer endovascular delivery platform for certain cell therapies, covering clinical development and commercialization.
- HeartWorks is a nonprofit biotechnology organization developing autologous cell therapies for congenital heart disease and sponsors the only active clinical study using autologous iPSC-derived cardiac cells for this indication.
- The Extroducer is FDA 510(k)-cleared for use in peripheral (including abdominal) tissues and is designed for catheter-based localized delivery to hard-to-reach organs and tissues.
SmartCella Holding AB has signed a non-exclusive license agreement with HeartWorks, Inc., a biotechnology organization founded to advance and commercialize autologous cell therapies for congenital heart disease. The agreement gives HeartWorks the right to use SmartCella’s Extroducer platform for the delivery of certain cell therapies, covering both clinical development and commercialization.
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The Extroducer is SmartCella’s modality-agnostic endovascular delivery platform designed for localized drug delivery to hard-to-reach organs, tumors, and tissues. Developed at Karolinska Institutet and FDA 510(k)-cleared for use in peripheral (including abdominal) tissues, it enables minimally invasive, catheter-based delivery using arteries and veins as natural access routes for localized injection of therapeutic agents into target tissues.
HeartWorks is a US-based nonprofit biotechnology organization dedicated to advancing regenerative therapies for congenital heart disease (CHD). Founded in 2020, HeartWorks develops personalized heart cell therapies designed to regenerate damaged heart muscle using a patient’s own cells. As the sponsor of the world’s only active clinical study using autologous iPSC-derived cardiac cells for congenital heart disease, HeartWorks is advancing regenerative therapies toward clinical translation.
Congenital heart disease is the most common birth defect, affecting approximately 1 in every 100 babies born and an estimated 2.4 million people in the US. For patients with complex single-ventricle heart defects such as hypoplastic left heart syndrome, today’s surgeries help patients survive but cannot replace or regenerate damaged heart muscle. As many patients develop heart failure later in life, transplantation often becomes the only remaining treatment option.
Dr Tim Nelson, CEO and co-founder of HeartWorks, says: ”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.”
Niklas Prager, CEO at SmartCella, comments: “We are thrilled to team up with HeartWorks, they are a truly purpose-driven organization and determined to find a cure for univentricular congenital heart disease. Knowing that our Extroducer® has a role to play in this vital work, and in the lives it has the potential to change, means a lot to us.”
The agreement reflects a long-term partnership that also covers other cardiovascular indications and supports both parties’ strategic ambitions. It follows SmartCella’s business model, with revenue generated across multiple streams throughout the partnership, including development and commercial milestones, royalties and product sales. The agreement is on similar general terms to previously announced agreements.
About SmartCella
SmartCella is a drug delivery company focused on targeted therapies. The Extroducer is currently in clinical investigation for additional indications. SmartCella commercializes the Extroducer through licensing agreements with biotech and pharma companies, enabling application across all development phases. The company also offers a proprietary stem cell platform for the delivery of mRNA therapeutics, featuring a proof-of-concept program focused on osteoarthritis.
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