Corgel® BioHydrogel biocompatible, patented hyaluronan hydrogel

Corgel^? BioHydrogel

Corgel? BioHydrogel is a biocompatible, patented hyaluronan hydrogel based on di-hydroxyphenyl linkages of tyramine substituted sodium hyaluronate (NaHy). Lifecore has licensed this technology from the Cleveland Clinic and has completed ISO 10993 safety and toxicity studies on this patented technology.

The resulting Corgel? has a wide range of physical properties depending on the tyramine substitution (TS) percentage and the tyramine substituted hyaluronan (TS-NaHy) concentration. Hydrogels formed from TS-NaHy solutions of 6.25 - 100 mg/mL display a spectrum of physical properties that include those of a weak gel, a paste, or a fractile solid.

• Corgel? Kits are available with 1%, 3%, or 5% TS of the NaHy.

• Depending on the targeted TS-NaHy concentration, Corgel? Kits yield a total of between 5 and 50mLs.

Corgel? Advantages

Potential Corgel? Applications

CORGEL INSTRUCTIONS

Corgel?Kits are available with 1%, 3%, or 5% tyramine substitution.

Depending on the targeted TS-NaHy concentration, Corgel?Kits yield a total of between 5 and 50mLs. Please see the Instructions for proper use.

DETAILED EXPLANATION OF THE CHEMISTRY OF CORGEL

Corgel? is for RESEARCH USE ONLY, NOT FOR HUMAN USE.

Both the functional groups, and the resulting cross-linked structures, have unique photometric properties that allow for easy evaluation of the degree of substitution and cross-linking. Importantly, the degree of substitution required for using Corgel is very low (1% - 5%), maintaining the native sodium hyalruonate structure.

A benefit of the Corgel technology is that this proprietary hydrogel can be formed under physiologic conditions. This allows for the direct inclusion of cells or bioactive agents prior to, during cross-linking, or alternatively, cross-linking directly adjacent to living tissue, maintaining cell and tissue viability.

Attached is a video showing Corgel's ability to occlude flow. This is just one potential example of Corgel's possible uses in transcatheter applications. The gel in the video was colored for viewing purposes only.

Publications Referencing Corgel?

• Darr, A., Calabro, A. Synthesis and characterization of tyramine-based hyaluronan hydrogels. J Mater Sci: Mater Med 2009; 20: 33-44

• Fumoto, H., Takaseya, T., Shiose, A., Saraiva, R.M., Arakawa, Y., Park, M., Rao, S., Dessoffy, R., Chen, J-F., Zhou, Q., Calabro, A., Banbury, M., Fukamachi, K. Mitral Annular Remodeling to Treat Functional Mitral Regurgitation: A Pilot Acute Study in a Canine Model. The Heart Surgery Forum 2010; 13(4): E247-E250

• Chin, L., Calabro, A., Rodriguez, E.R., Tan, C.D., Walker, E., & Derwin, K.A. J Mater Sci: Mater Med 2011; Printed online May 2011

• Chin, L., Calabro, A., Walker, E., & Derwin, K.A. Mechanical properties of tyramine substituted-hyaluronan enriched fascia extracellular matrix. Journal of Biomedical Materials Research Part A 2012; Printed online January 11, 2012

General Information on the FDA's Position on Cell/Scaffold Products

• McCright, B., et al. Synopsis of the Food and Drug Administration-National Institute of Standards and Technology Co-Sponsored "In Vitro Analyses of Cell/Scaffold Products" Workshop. Tissue Engineering: Part A 2009; 15: 1-6

General Information Discussing Hyaluronan-Based Hydrogels

• Hilborn, J. In vivo injectable gels for tissue repair. Wiley Interdisciplinary Reviews: Nanomedicine and Nanobiotechnology 2010; Published online July 21, 2011

• Jatav, V.S., Singh, H., & Singh, S.K. Recent Trends on Hydrogel in Human Body. International Journal of Research in Pharmaceutical and Biomedical Sciences, 2011; 2(2); 442-447

Corgel? BioHydrogel Pricing

One Corgel? Kit includes 250 mg of Tyramine-Substituted Sodium Hyaluronate (TS-NaHy), 25 mL Horseradish Peroxidase (HRP) in PBS (10 U/mL), and 5mL Hydrogen Peroxide (H₂O₂) in PBS (1.0%).

Corgel? Kit Pricing

Corgel? Sampler Pack includes one Kit of each substitution

• Part #85 Corgel? Kit 1%

• Part #85 Corgel? Kit 3%

• Part #85 Corgel? Kit 5%

• Total: $400 (an 11% savings)

Corgel? Powder includes 250 mg powder, Tyramine-Substituted Sodium Hyaluronate (TS-NaHy)

Plus $25 per order for special handling.

RESEARCH USE ONLY, NOT FOR HUMAN USE.