Handheld Adipose Stem Cell Processor for Point of Care Application

Tissue Genesis (TGI) is developing a low-cost, highly portable, fully automated adipose-derived stem cell (ADSC) isolation device that addresses current technology limitations including sterility breaks, process time, complexity, and cost. It is an outpatient cell recovery system that prioritizes cell yield, viability, and purity by using novel processes with improved biomaterials. The Phase I SBIR has successfully shown the feasibility of the new technologies being employed in the device, and has defined the path for prototype development. Phase II will take a prototype through iterative design and testing cycles, arriving at a matured product design that will produce high purity ADSCs suitable for all clinical applications. By leveraging ongoing FDA IDE trials and approvals, subsequent efforts will be structured to demonstrate equivalence with the companys industry leading TGI Icellator Cell Isolation System, thereby fast-tracking commercial introduction and use of the new device. In aggregate, this development will produce a commercially viable device that makes access to ADSCs simple, rapid, and cost effective, thereby making therapies using adult stem cells feasible in mainstream medicine for both warfighters and civilians worldwide.