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THERAPEUTIC SILICONE TECHNOLOGIES, INC.

ABOUT US	OFAS has created a clinical research division, Therapeutic Silicone Technologies, Inc. (TST), specifically for the development of therapeutic purified silicones. Clinical trials will include patients suffering from cutaneous complications of various conditions, including diabetes and the human immunodeficiency virus (HIV). TST does not manufacture or sell the therapeutic products it develops; however, it licenses the proprietary technology for commercial distribution, using proceeds to fund on-going clinical trials, research, and development.
OUR MEDICAL DEVICES	Silikon® 1000 for use as prolonged retinal tamponade In 1997, TST’s predecessor (Richard-James, Inc.) received approval from the US Food and Drug Administration for Silikon 1000, a purified polydimethylsiloxane indicated for use as a prolonged retinal tamponade in selected cases of retinal detachment. Since 1997, Silikon 1000 has been used safely and efficaciously, preserving sight and quality of life that would have otherwise been lost in tens of thousands of patients. Silikon 1000 is manufactured and distributed by Alcon Laboratories, Inc., Fort Worth, TX. For more information, please see www.silikon1000.com. Podiasil™ for prevention of ulcers in the diabetic foot TST is finalizing the protocol for a multi-center, 275-patient clinical trial to evaluate the safety and efficacy of PodiaSil, a purified polydimethylsiloxane, for preventing ulcers in the diabetic neuropathic foot. Pre-clinical evidence and well-controlled clinical evaluations indicate that PodiaSil reduces the occurrence of diabetic foot ulcers, the leading cause of non-traumatic lower extremity amputation in the US. In the US the cost of diabetes management was $132 billion in 2002. Of that amount, 10% is attributed to costs associated with complications of lower extremity wounds. PodiaSil, a compliance-free therapy that significantly reduces the frequency of such ulcers, will substantially reduce the total cost of diabetes-related health care and significantly improve the quality of life of diabetics susceptible to foot ulceration. SilSkin™ for rhytids, depressions, and HIV-associated lipoatrophy In October 2001, TST obtained approval from both the US FDA and Health Canada to commence clinical studies to evaluate the safety and efficacy of SilSkin, a 1000-centistoke, highly purified polydimethylsiloxane, for augmenting facial wrinkles and depressions. A multi-center study was successfully completed in 2004. In 2005, TST received approval from the US FDA to initiate a clinical study evaluating the safety and efficacy of SilSkin to treat HIV-associated lipoatrophy, or facial wasting. Lipoatrophy presents significant psychosocial challenges for affected patients and can impair compliance with anti-viral drug regimens. TST is currently in the process of licensing the intellectual property associated with SilSkin.
CONTACT US	Licensing Opportunities Anna-Sophia Leone, Vice President 212/606-0840 asleone@therasil.org Quality Assurance Bernardita Calinao, PhD 212/606-0830 bcalinao@therasil.org General Information Raeanne Sanders, Coordinator 212/606-0828 rsanders@therasil.org