From vascular advancements to visions of organ transplants, our regenerative innovations are harnessing the body’s own ability to heal.
Humacyte’s platform technology has the potential to change the lives of countless people around the world by overcoming the current limitations in existing standards of care. We are leveraging our scalable technology platform to develop bioengineered human tissues for use in the treatment of diseases and conditions across a wide range of clinical needs. We are initially using our technology to bioengineer and manufacture human acellular vessels, or HAVs, in varying sizes to address the significant unmet needs across multiple potential indications in vascular repair, reconstruction and replacement. HAVs are currently being investigated across multiple clinical trials in vascular trauma, AV access for hemodialysis, and peripheral arterial disease. Our pipeline vision is to evolve the utility of the HAV technology and develop future opportunities for coronary artery bypass grafting, pediatric heart surgery, the delivery of cellular therapies- including transplant of islet cells to treat Type 1 diabetes patients, and one day engineered solutions for complex tissue systems and organ transplants.
Esophagus2 of 9
Dialysis AV Access4 of 9
Peripheral Arterial Disease (PAD)5 of 9
Coronary Artery Bypass Grafting (CABG)6 of 9
Lung7 of 9
Pancreas8 of 9
Urinary Conduit9 of 9
Groundbreaking Manufacturing Infrastructure
Humacyte has developed a novel paradigm for manufacturing human tissues that is intended to mimic key aspects of human physiology. We have an 80,000+ square foot bioprocessing facility housing our modular manufacturing process with the ability to manufacture HAVs and future products at commercial scale. The platform technology is supported by manufacturing infrastructure, a proprietary cell bank, and proprietary biomanufacturing processes operating at a commercial scale.
Our headquarters in Durham, N.C., features state-of-the-art cGMP manufacturing space, capable of an anticipated annual production capacity of over 40,000 HAVs with our LUNA200 bioreactor system. By managing the manufacturing process end-to-end, we are able to modularly scale the production capacity while retaining a high level of process uniformity. The facility is also home to our Research & Development, Process Development, and Quality Control laboratories, along with our Business, Clinical, and Regulatory operations.
Bioengineering Human Vessels
Our first product candidate, the HAV, is made by seeding vascular cells from a qualified cell bank onto a biocompatible, biodegradable polymer mesh in a bioreactor bag. Over weeks, the cells grow and create new tissue, forming a tube-shaped vessel structure while the polymer mesh degrades. The resulting bioengineered vessel is then decellularized to create the HAV: an extracellular matrix that retains the biomechanical properties of the vessel but is cleansed of cellular components that could induce an immune response. The HAV in the bioreactor bag can then be shipped, stored, and immediately available when needed. We are currently conducting Phase II and Phase III trials of our 6-millimeter HAV across two therapeutic indications, vascular trauma and AV access for hemodialysis, as well as continuing long-term follow up of patients in our Phase II PAD studies. The HAV is supported by robust clinical efficacy and safety data in 430+ patients and is the first product to receive Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration, and has also received FDA Fast Track designation for the creation of vascular access for performing hemodialysis.
How it Works
The HAV is a true breakthrough in regenerative medicine. Here’s why.
The Future of Engineered Tissues
Type 1 diabetes, caused by auto-immune destruction of insulin-producing beta cells in the islets of the pancreas, is a devastating disease affecting more than 1.25 million people in the United States. Research shows that less than one third of Type 1 diabetes patients achieve consistent target blood sugar levels. The Biovascular Pancreas (BVP) is a modification of the Humacyte HAV product, leveraging the properties of the HAV to transplant therapeutic cells into proximity of the bloodstream to support islet graft oxygenation and vascularization. Our early scientific studies show that the BVP can normalize blood glucose in a Type 1 diabetic model, leading us to believe that scaling to human islet delivery should be feasible. We are working with potential partners to bring the human BVP into clinical testing and believe this will be one of the foundations for the development of more complex tissue systems.
Trailblazing the Development of Whole Organs
End-stage lung disease is the fourth leading cause of death in the United States, and lung transplantation remains severely limited by donor organ shortages. Our CEO, Dr. Laura Niklason’s laboratory at Yale University has pioneered the development of using decellularized native lungs, with targeted recellularization of the lung scaffolds, to produce whole lungs that are capable of exchanging gas. Early studies have demonstrated gas exchange for several hours in small animal models. Efforts to scale-up the technology to human-sized organs are ongoing, further evolving the potential of regenerative medicine. Humacyte believes that our platform technology could have an immense impact on the development and realization of engineering whole replacement lungs, advancing the future of organ transplantation today.
“Readily Available Tissue-Engineered Vascular Grafts”1 of 7 Lancet 2016
“Bioengineered Human Acellular Vessels for Dialysis Access in Patients with End-Stage Renal Disease: Two Phase 2 Single-Arm Trials”2 of 7 Science 2019
“Bioengineered Human Acellular Vessels Recellularize and Evolve into Living Blood Vessels after Human Implantation”3 of 7 TACS 2019
“Clinical Implementation of the Humacyte Human Acellular Vessel: Implications for Military and Civilian Trauma Care”4 of 7 Science 2020
“Bioengineered Human Blood Vessels”5 of 7 JVS 2020
“Arterial Reconstruction with Human Bioengineered Acellular Blood Vessels in Patients with Peripheral Arterial Disease”6 of 7 Learn More
Explore the Humacyte publications library7 of 7