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Imagenetix seeks to be a leader in conducting cutting edge scientific studies on its proprietary, natural-based bioceutical products. Where appropriate, those Imagenetix products that are proprietary and substantial enough to participate in multi-million to multi-billion dollar markets will be subjected to professionally designed clinical studies. Imagenetix begins by focusing on an existing large-scale consumer need or issue. Science is developed around a clearly identified need or challenge that already exists on a global basis. The Company identifies and develops natural-based products that may provide a solution to that challenge. Studies are designed that could produce insight into such important issues as toxicity and effectiveness. Top laboratories, universities, and clinics are utilized. Recognized doctors and researchers with published backgrounds are selected to oversee the studies. By involving top caliber professionals, the Company is able to quickly gain confidence in determining whether or not to proceed with ongoing studies. If the Company proceeds with studies, and if the results are positive, the findings by these professionals are likely to receive support throughout the industry. By utilizing this process, the Company has automatically increased its odds of getting its scientific findings published While conducting tests, Management focuses on three main ways in which its scientifically tested products might ultimately be marketed: First: The majority of the Company’s research will lead to products that will quickly find their way to market as oral or topical natural-based products and where the Company can make structure/function claims for the oral products, or OTC drug claims or cosmetic claims for the topical products. Effective scientific results will allow distributors to market and consumers to buy products with confidence. With solid science, many distribution channels can be utilized. Second: Under certain circumstances, health claims can be applied to natural-based products that are sold over the counter, i.e., on a non-prescription basis. This occurs when it can be clinically demonstrated that the product is efficacious in addressing a specific health issue. In such a case, toxicity studies must be conducted and a filing must be made to the FDA. Upon approval by the FDA, these products can be marketed through the same distribution channels mentioned above, but they would have the added marketing advantage that a health claim could be expressed and used in advertisements when marketing these products. Imagenetix is currently proceeding with product studies that it plans to bring through this process. Being able to make health claims would clearly distinguish Imagenetix from many competitors in the natural product area. Third: Although Imagenetix is not in the drug development business, the Company seeks to conduct studies and develop science that is clear and compelling and that could catch the interest of pharmaceutical companies. Positive scientific results from Imagenetix studies coupled with the ability to gain patent protection may provide an opportunity for the Company to enter into licensing agreements with pharmaceutical companies. Because management believes that licensing of select products is a realistic possibility, both scientific studies and patent applications of products will involve well-respected professionals. Professionals with solid experience and strong reputations provide comfort and proper information to pharmaceutical companies interested in the licensing process. With a licensing agreement in place, it would become the responsibility of the pharmaceutical company to spend the money and conduct studies that would turn the product into an approved and marketable drug. Imagenetix is in the early stages of moving down this path with one of its products. Scientific Bibliography Scientific Presentations: 1. Kraemer WJ, Ratamess NA, Anderson JA, Tiberio DP, Joyce ME, Messinger BN, French DN, Sharman MJ, Rubin MR, Gomez AL, Volek JS, Hesslink R Jr. (2003) The effects of cetylated fatty acid cream on pain, range of motion and quality of life of patients with osteoarthritis. American College of Sports Medicine, San Francisco, CA. 2. Ratamess NA, Kraemer WJ, Anderson JA, Tiberio DP, Joyce ME, Messinger BN, French DN, Sharman MJ, Rubin MR, Gomez AL, Volek JS, Hesslink R Jr. (2003) The effects of a cetylated fatty acid cream on functional mobility and performance in patients with osteoarthritis. American College of Sports Medicine, San Francisco, CA. 3. Islam A, Gallaher C.M., and Gallaher D.D. (2003) Absorption and metabolism of a cetylated fatty acid. Experimental Biology, San Diego, CA. 4. Gallaher D.D., Gallaher C.M., Hesslink R. Jr. (2002) Digestion and metabolism of cetylated fatty acids in rats. Experimental Biology, New Orleans, LA. 5. Hesslink R.L., and Sprouse S. (2002) The effects of a cetylated fatty acid complex on canine osteoarthritis. 2nd International Symposium on Rehabilitation and Physical Therapy in Veterinary Medicine, Knoxville, TN. 6. Barathur R.R., Bookout J.B., Sreevatsan S, Freedland E.S. and Hesslink Jr., R.L. (2001). A fatty acid ester (CMC) improves quality of life outcomes in osteoarthritis (OA) patients. Experimental Biology, Orlando, FL. Publications: 7. Kraemer W.J., Ratamess N.A., Anderson J.A., Maresh C.M., Tiberio D.P., Joyce M.E., Messinger B.NB., French D.N., Sharman M.J., Rubin M.R., Gomez A.L., Volek J.S. and Hesslink, Jr., R.L. (2003) The effects of a cetylated fatty acid topical cream on functional mobility and quality of life of patients with osteoarthritis. In review, J. Rheumatology. 8. Hesslink Jr. R.L., Armstrong III D.A., Nagendran M.V., Sreevatsan S, and Barathur R. (2002) Cetylated fatty acids improve knee function in patients with osteoarthritis. J Rheumatology, 29:1708-1712. 9. Islam A, Gallaher C.M., and Gallaher D.D. (2003) Absorption and metabolism of a cetylated fatty acid. FASEB J. 17(4): A341. 10. Gallaher D.D., Gallaher C.M., Hesslink R. Jr. (2002) Digestion and metabolism of cetylated fatty acids in rats. FASEB J. 16 (4): A365. 11. Barathur R.R., Bookout J.B., Sreevatsan S, Freedland E.S. and Hesslink Jr., R.L. (2001). A fatty acid ester (CMC) improves quality of life outcomes in osteoarthritis (OA) patients. FASEB J. 15(4): A265. Technical Reports: 12. Bacterial reverse mutation Ames test screening. (2002) MDS Pharma, Les Oncins, France. 13. Evaluation of topical cetylated fatty acid application to psoriasis patients. (2002) Dermatologist Medical Group of North County, Inc. 14. The acute toxicology of oral cetylated fatty acid gavage CD-1 mouse model. (2001) Perry Scientific, Inc., Study No. 00-1075. 15. Evaluation of a topical
cream containing cetylated fatty acids
using hairless
mouse model. (2000)
Perry Scientific, Inc., Study
No. 00-1076. |
