Our restorative cell therapy platform is comprised of innovative bioengineering, advanced proprietary materials sciences as well as molecular and cellular biology technologies that can be utilized individually or in a variety of combinations to create opportunities to broaden our pipeline and /or expand geographically. Specifically, our RCT platform includes:
Cell Processing: Our cell processing technologies involve the handling of a biopsy specimen in our own cGMP facilities, cell extraction from the biopsy and the isolation and expansion of cells in our segregated cell culture facility. These steps effectively return such cells to their juvenile phenotype where they may once again grow and expand into mature cartilage cells. Our proprietary process is currently optimized for, but not limited to, cartilage cell culturing.
Three-Dimensional Scaffolds (Biomaterials): Scaffolds are structures capable of supporting three-dimensional tissue formation and providing an environment for the cells that are needed to form the tissue. Our proprietary, scaffold structures, including our honeycomb collagen scaffolds, are designed to produce cartilage-like tissue. The term “honeycomb” describes the shape of the pores inside of the scaffold. The honeycomb structure is important because it allows cartilage cells to line up vertically throughout the scaffold so that they organize as they normally would in native cartilage. Our proprietary three-dimensional scaffolds can support and deliver a variety of cell types and are biocompatible, biodegradable and non-toxic.
Tissue Engineering: Tissue engineering refers to applications that repair or replace portions of or whole tissues such as cartilage, bone, blood vessels and skin. Our proprietary tissue engineering processors (TEPs) incubate our cell- and scaffold-based implants under conditions designed to mimic the conditions found in the knee, including pressure changes and low oxygen levels. We believe our proprietary TEP technology is unique to the tissue repair market and is one of the reasons patients receiving a NeoCart implant in our Phase 1 and Phase 2 clinical trials recovered more quickly and realized positive long-term outcomes as compared to patients receiving microfracture surgery.
Bioadhesive: Our proprietary bioadhesive, CT3, secures the NeoCart in the defect and eliminates the need for complicated suturing that may be required during other cartilage repair treatments. CT3 is biodegradable, non-toxic and comprised of three components: methylated collagen, activated polyethylene glycol (PEG) and a simple salt buffering solution that acts as a curing component. The curing component enables the physician to rapidly control the adhesive set-time, which, we believe both simplifies and expedites the procedure relative to other autologous cartilage repair treatments. We believe CT3 also contributes to the quick recovery and the positive long-term outcomes seen in our Phase 1 and Phase 2 clinical trials.
We believe we can leverage this platform and our long history of manufacturing capabilities to develop NeoCart for additional indications such as the repair of cartilage defects in the ankle and hip and create collaborations to commercialize NeoCart in markets outside of North America.