SBIR-STTR Award

Tissue Genesis® (TGI) is proposing to develop a highly portable, easy to use, low-cost, point-of-care, adipose-derived stem cell (ASC) isolation device that fully integrates the process from fat extraction to cell product. This next generation system addresses current technology limitations including: sterility breaks, acquisition and process time, complexity of operation, and cost. The convenient and rapid recovery of millions of regenerative cells will fill the unmet need as a readily available source of adult stem cells for therapeutic use across multiple military trauma needs, such as wound healing, tissue and nerve repair, orthopedic injury repair, plastics and aesthetics, ophthalmology, and otolaryngology. The proposed system addresses current technology, cost, and convenience shortfalls and allows for a rapid translation of regenerative stem cell therapeutics into the clinic.

Keywords:
adipose stem cell, cell processing, cell harvesting, regenerative medicine, cell therapy, personalized medicine

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 company’s 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.