Device Automation of an FDA-cleared CD-Microfluidic Platform for Rapid Tissue Microsizing

ABSTRACT There is a need in the market for a true platform technology that automates the tissue processing experience. Syntr Health Technologies has dedicated the last nine years to developing the technology that can streamline tissue processing. Our FDA-cleared SyntrFuge System and SyntrFPU360, is a platform technology that can process a variety of different tissue types such as cancer tumors of kidney, liver, brain, and breast tissue by dissociating them into single cells to better understand tumor tissue heterogeneity, of which the single cell analysis market is valued at $3.3 Billion and expected to grow to $6.3 Billion by 2026. Additionally, our platform can be used to microsize autologous adipose tissue to be used for reinjection back into the patient to treat medical conditions of the aging population such as diabetic foot ulcers, knee osteoarthritis, and breast cancer reconstruction surgery. Syntr Health successfully completed an SBIR Phase I grant where we utilized microsized adipose tissue to heal diabetic ulcers in an animal model. This study had an important role in developing a treatment modality that translated successfully into humans. Preliminary human clinical data shows significant diabetic foot ulcer wound closure within 28 ± 4 days using autologous adipose tissue processed in our platform. The diabetic foot ulcer market is currently valued at $1.98 Billion with a CAGR of 8.2%. This high growth potential is attributed to the increase of the diabetic population. Moreover, the use of microsized adipose tissue is showing great promise in intra-articular injections to knee joints for the treatment of osteoarthritis (OA). The knee OA market in North America is currently valued at $5.9 Billion and growing at a CAGR of 8.8%. Over 88% of individuals with OA are 45 or older. The high growth potential of this market is largely attributed to the increase of the aging population along with the increase in obesity rates. Our platform technology for the rapid processing and/or microsizing of tissues can disrupt these markets in a major way. The full automation and market readiness of this technology in this Phase II SBIR is paramount to increase favorability in the adoption of this much needed technology in various medical fields..