VERIDIEN CORPORATION STARTS 30-DAY CLINICAL TRIALS FOR NEW CHEMICAL COLD STERILANT
VERIDIEN CORPORATION STARTS 30-DAY CLINICAL
TRIALS FOR NEW CHEMICAL COLD STERILANT
SARASOTA, Fla., Jan. 20 /PRNewswire/ -- Veridien Corporation, a health care company with headquarters in Sarasota, Fla., announced today that it is beginning 30-day clinical tests this week for its new chemical cold sterilant. The clinical testing will be conducted with major universities and medical institutions and their Institutional Review Boards, in accordance with the FDA's Investigational Device Exemption (IDE) regulations.
The company recently received a letter from the FDA identifying data needed to complete its pending Premarket Notification Submission (510|k~ application) for the new cold sterilant. The sterilant would be marketed to hospitals and physicians' and dentists' offices for sterilizing surgical and other medical instruments, including dental handpieces and burrs, if approved by FDA.
The company's FDA application claims that the new sterilant kills spores, bacteria, viruses, and tuberculosis in minutes at room temperature. By contrast, sterilants now on the market take from 6 to 10 hours. The Veridien chemical cold sterilant also differentiates itself from the present market of glutaraldehyde products because it is a non-glutaraldehyde-based sterilant.
Veridien's sterilant formulation is based upon a proprietary, biochemically-engineered technology that adds a single ingredient to its hospital-grade disinfectant. This disinfectant is fast-acting, highly efficacious, easy to use and low in toxicity, and has already received EPA registration. Veridien plans to market a product line that includes both the sterilant and the hospital-grade disinfectant.
"The clinical tests beginning this week are intended to further corroborate the usefulness of our product, the efficacy of which has already been tested in the laboratory," said Robert E. Yaw II, chairman and chief executive officer of Veridien. "We're moving quickly and hope to measure these tests in weeks, not months."
The Veridien chemical cold sterilant and disinfectant are infection control products in a category currently being reviewed by FDA. Recently, several competitive glutaraldehyde-based products under the Sporicidin brand name were subject to a seizure order by FDA for lack of efficacy.
Veridien, formerly Viral Control Technology, is a Delaware corporation quoted on the OTC Electronic Bulletin Board under the symbol "VERD."
/CONTACT: Lauren Letellier of Burson-Marsteller, 212-614-5253, for Veridien Corporation/
(VERD) CO: Veridien Corporation ST: Florida IN: MTC SU: SM -- NY046 -- 1488 01/20/92 15:10 EST