Company Profile: Isolagen, Inc. (ILE)

Isolagen, Inc., founded in 1995 and located in Houston, Texas, has become an emerging force in biotechnology by specializing in the development and commercialization of its autologous cellular system (ACS) technology.

With four secured patents and an additional patent pending, the Isolagen Process represents a unique breakthrough in ACS technology in the overall approach to cosmetic and medical therapy. Specifically, the Isolagen Process has applications in cosmetic dermatology, cosmetic surgery, periodontal disease, and reconstructive dentistry, among other therapies.

The Isolagen Process is a novel process whereby a patient’s own collagen-producing cells (fibroblasts) are extracted, reproduced, and then re-introduced by injection back into the patient’s treatment area. Unlike other collagen development companies, Isolagen uses only the patient’s unique, living cells to produce the patient’s own collagen. There is no foreign substance utilized in this treatment protocol, and the results are significantly longer lasting than other techniques. Isolagen’s vision is to be the industry leader in the research, development, and commercialization of ACS tissue regeneration.

The U.S. Food and Drug Administration ("FDA") began regulating the science of biologics. Biologics, in contrast to drugs that are chemically synthesized, are derived from living sources (such as humans, animals, and microorganisms) like ACT and the Isolagen Process. The Company is pursuing the FDA approval process in collaboration with FDA consulting firms. Present interpretation of the published regulations places the Isolagen process under the Center for Biological Evaluation and Research ("CBER"). The regulations define manipulation of autologous cell therapies at various levels. The present understanding is that the Isolagen process falls within the legislation for minimally regulated products. Isolagen filed an investigational new drug application ("IND") covering the Isolagen Process with the FDA. Isolagen has commenced a retrospective study of its extensive patient database to answer specific FDA related issues prior to submission of an amended IND.