August 2, 2004.
Theragenics Corporation(R) (NYSE: TGX), the Georgia-based manufacturer and marketer of TheraSeed(R), the premier palladium-103 cancer treatment device, today announced that it has been granted an Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration to initiate its TheraSight(TM) clinical trial. The TheraSight(TM) Trial is designed to evaluate the safety and feasibility of the TheraSight(TM) Ocular Brachytherapy System for the treatment of subfoveal choroidal neovascularization associated with exudative (wet) age-related macular degeneration (AMD). This is a pilot study of three doses of radiation delivered to thirty patients at up to six clinical sites. Favorable results of this study may be used to expand to a larger trial designed to test the safety and effectiveness of the TheraSight(TM) System.
Thomas A. Ciulla, M.D., Retina Specialist at Midwest Eye Institute in Indianapolis, and Principal Study Investigator for the TheraSight(TM) Trial, commented, "I'm extremely pleased that Theragenics(TM) is evaluating the role of brachytherapy for exudative AMD. I'm optimistic that there is a potential role for the TheraSight(TM) device for some forms of wet AMD, and perhaps those ineligible for other treatments, refractory to other treatments, or in combination with other AMD therapy to improve outcomes."
Commenting on the IDE approval, Ms. M. Christine Jacobs, Chairman, CEO and President, stated, "We are thrilled with this important development. Blindness due to this disease is devastating to family and patients alike. We are hopeful our device may alleviate this condition. The trial will also aid us in evaluating palladium-103 for other disease states. Additionally, this trial brings us another step closer to diversifying the Company through the design of new medical devices based on our expertise with the palladium-103 isotope."
Age-related Macular Degeneration (AMD) is the leading cause of blindness in the United States. There are two types of macular degeneration, dry and wet. The TheraSight(TM) system is designed to treat the wet form of the disease. With wet AMD, abnormal blood vessels form beneath the macula and leak a fatty fluid that causes the macula to bulge, distorting central vision. While the wet form accounts for only ten percent of cases of macular degeneration, it is responsible for almost 90 percent of the severe vision loss associated with AMD. Each year approximately 200,000 new cases of wet AMD are diagnosed in the U.S.
Theragenics Corporation(R) is committed to being a leading provider of brachytherapy treatment devices for prostate cancer and other degenerative disease states. The Company is the manufacturer and marketer of the palladium-103 device TheraSeed(R) and I-Seed, an iodine-125 based device. Both devices are used in the treatment of localized prostate cancer in one-time, minimally invasive procedures. Theragenics(TM) is the world's largest producer of palladium-103 and is involved in research and development utilizing palladium-103 and other isotopes for the treatment of a wide variety of diseases, including vascular disease and macular degeneration. For additional information on the Company, call Theragenics'(TM) Investor Relations Department at (800) 998-8479. The Company's common stock is traded on the New York Stock Exchange under the symbol TGX. Additional information can be found on the Company website: www.theragenics.com.
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