BUSINESS WIRE - 44 Montgomery St, 39th Floor, San Francisco, CA 94104; Tel: (415) 986-4422; FAX: (415) 788-5335 BW URL: http://www.hnt.com/bizwire - BW1095 DEC 20,1995 9:12 PACIFIC 12:12 EASTERN
The study was funded by Steril-Med Inc. (TM) of Houston, which is affiliated with Cooley & Cooley Ltd., manufacturer of Copalite (R) dental products for worldwide distribution.
Dr. William D. Welch, Medical Discoveries' president, said that current sterilizing methods used by dental and medical professionals include autoclaving and treatment of instruments with ethylene oxide. Welch emphasized that autoclaving requires a minimum of 20 minutes excluding the labor involved in preparing and removing such sterilized instruments.
"Our first phase evaluation clearly demonstrates the ability of MDI-P to kill highly resistant microorganisms in three minutes or less," Welch said, adding that continued autoclaving of instruments damaged them and ultimately resulted in high replacement costs. Ethylene oxide is a biohazardous toxic gas used primarily by large hospitals for the sterilization of heat sensitive instruments or materials such as plastics.
Welch estimated that the annual cost of repairing and replacing handpieces for the approximately 130,000 dentists in the U.S. is about $17,000 per dentist, labor costs not included. "Our MDI-P procedure would be extremely cost competitive with these two traditional sterilizing methods."
The principal trial investigators were Drs. Welch and Robert Kolstad. Kolstad is professor of dentistry and chief of the sterilization and monitoring department at Baylor. Their initial experiments were designed to assess the ability of MDI-P to kill specific concentrations of Bacillus subtilis spores, a highly resistant test microorganism recommended by the FDA for such evaluations. Controls were included to prove that no accidental killing of these spores had occurred. When the initial testing was concluded, no viable spores were detected after a three minute exposure period.
"These unequivocally successful preliminary trials encourage us to believe that the further studies required for FDA premarket notification (510K) submission will also be successful. With appropriate funding, these additional studies should be completed by late 1996," Welch concluded.
Medical Discoveries Inc. has also developed a treatment that appears to have the ability to kill viruses and bacteria. The company has filed several patent applications with the U.S. and Trademark Office, covering the application of its product, known as MDI-P, to a variety of human diseases including AIDS. The company has already received patents with respect to the application of MDI-P to multiple sclerosis and cardiomiopathy. Medical Discoveries has submitted a pre-IND application to the FDA for the use of MDI-P as a new treatment for HIV positive patients.
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CONTACT: Medical Discoveries Inc., Salt Lake City Marlin Toombs, 801/273-7388
or
The Cavior Organization Inc., New York Warren J. Cavior, 212/687-6070
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