Bacterial nanocellulose (BNC) has gained significant scientific interest during last few years as an emerging biomaterial for applications as vascular grafts, scaffolds for bone regeneration, cartilage tissue repair surgical meshes and skin substitute. The unique combination of good biocompatibility with good mechanical properties makes BNC attractive for variety of applications in tissue engineering and regenerative medicine. Successful commercialization of BNC medical devices requires however reproducible device biofabrication processes and extensive preclinical in vitro and in vivo evaluation to guarantee safety and performance of this new biomaterial. Each processing step has to be developed for full-scale production in a cGMP environment. Although successful FDA approval for simple devices may be based on 510 k process, more advanced devices may require clinical trials. There is only very limited literature data on BNC long term performance in preclinical studies and only one report on clinical performance of BNC in the human body. There is also very limited literature on the effect of the purification processes on endotoxin content, tissue integration and biomechanical performance. Collaborative efforts from the BNC scientific and corporate community are highly desirable in order to promote broad use of BNC as implants and biomaterials for regenerative and reconstructive surgery.

Innovative bacterial nanocellulose medical devices: From incubator to human body

245th National Meeting (2013)

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