Humacyte, Inc

The Potential of Our Investigational Human Acellular Vessels

Behind the rigor of our research methods, our scalable production process, and our well-planned clinical trials, we have a guiding goal: Lifesaving and long lasting vascular access or replacement for patients with End Stage Renal Disease. Our investigational human acellular vessels (HAVs) make this goal possible. Subject to future clinical trials and regulatory approval, our vessels have the potential to offer patients and vascular surgeons the opportunity for significant advances for vascular access:

How We Produce Our Investigational HAVs

At Humacyte, we currently manufacture HAVs for investigational use through a unique bioreactor cell culture process followed by a multi-step decellularization process which (according to presently-available data) removes cellular components from the tissue-engineered vessel. We have also developed a scalable, functionally-closed manufacturing process using automation and plastic-based bioreactors.

Following further development and regulatory approval, our goal is to design and create a manufacturing process to produce commercial quantities of our investigational HAVs and conduit products in a scalable, cost-effective manner.

Our ongoing research and development activities include pilot scale operations in our current Humacyte cGMP manufacturing space as well as plans to transition to large scale campaign production. We have already produced Phase I and II clinical supplies in our current space, and anticipate continued evolution of our broader scaled system in 2016 and beyond.