Currently, the Company has two main product lines: breast implants for aesthetic plastic and reconstructive surgery; and scar management products.
The Company’s primary product line is breast implants. The Company has a strategy of establishing or acquiring manufacturing and distribution capabilities for this product line. Historically, the Company acted as a distributor in the United States for breast implant products manufactured by a third-party manufacturer. In May 2004, the Company agreed to purchase and in July 2004 it closed on the acquisition of Eurosilicone. Based on the Company’s evaluation of available industry data, Eurosilicone is the third largest breast implant manufacturer in the world.
Prior to May 2000, through its III Acquisition Corp. subsidiary, which does business under the trade name PIP.America, the Company distributed in the United States pre-filled saline breast implants manufactured by PIP, on both a direct and a consigned inventory basis. As of May 2000, the FDA notified PIP.America and PIP that further direct sales to customers by PIP.America would be suspended until the FDA reviewed and approved the clinical study being conducted by PIP. Pursuant to a voluntary withdrawal from the market, sales of PIP.America products ceased in November of 2002 pending final PMA clearance.
In April 2002, the Company agreed to acquire substantially all of assets of another privately-held United States breast implant distributor whose principal product line consists of inflatable saline breast implants. As in the case of PIP\'s products, these were also available in the U.S. prior to May 2000. The closing of this asset acquisition is conditioned upon the distributor acquiring necessary governmental approvals for commercialization in the United States of the products to be distributed. At June 30, 2004 the Company recorded a reserve against all acquisition advances due to various uncertainties related to this third-party distributor. During the quarter ended September 30, 2004, the Company received various communications from this distributor which raise significant uncertainty about the likelihood or timing of a successful commercialization of these products.
The Company’s subsidiary, HPL Biomedical, Inc., which does business under the trade name Biodermis, manufactures and sells products in the specialty field of scar management and post-operative care products. In the United States, Biodermis distributes its products to dermatologists, dermatological surgeons, aesthetic plastic and reconstructive surgeons and Obstetric/Gynecologists through a combination of a direct sales force and a distributor. Internationally, Biodermis distributes to the same fields of medicine through approximately 70 distributors in about 50 countries, including Canada and Mexico. Biodermis\' core product line consists of products indicated for use in the prevention and management of excessive or abnormal masses of visible scar tissue known as keloid and hypertrophic scars. In the United States, the products are distributed under the names EpiDermTM silicone gel sheeting and XeragelTMsilicone ointment. Internationally, the same products are also marketed under the names TopiGelTM and DermaSofTM.
Biodermis\' secondary product lines consist mainly of two products, EPIfoamTM and HydroGOLDTM. EPIfoam is a silicone backed, polyurethane foam utilized post-lipectomy to assist in recovery and enhance the overall aesthetic appearance following liposuction. HydroGOLD is a hydrogel-based product for use in reducing the pain, discomfort and burning sensation frequently associated with procedures of the skin typically aimed at reducing fine lines and wrinkles and to eliminate or reduce the signs of aging, such as laser resurfacing, chemical peels and micro-dermabrasion.