Human Acellular Vessels
Our first product candidate, the HAV, is made by seeding vascular cells from a qualified cell bank onto a polymer mesh in a bioreactor bag. Over weeks, the cells grow and create new tissue, forming a tube-shaped vessel structure. 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. 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.
How it Works
Potential Benefits Of Investigational HAVs
The HAV is designed to solve key problems with the current limitations of vessel tissue repair and replacement:
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 over 80,000 sq. feet of on-site, 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.