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BioNeutral Group, Inc., a specialty life science technology-based company, announces that it has received approval and registration from the Environmental Protection Agency (EPA) in response to the company's regulatory application for its Ygiene 206.
In order to obtain regulatory approval for its hospital and industrial-grade line of products to be used as high-level disinfectant and sterilants, in August 2010, following several years of research and development under the direction of BioNeutral chief scientist Andrew Kielbania, PhD, and in collaboration with Philip Tierno, PhD, chairman of its scientific advisory board, BioNeutral submitted an extensive EPA application along with the required independent GLP laboratory testing results.
After an intensive six month review of the nearly 1,500-page document, the EPA has granted its approval and registration (Reg No: 81242-1) for BioNeutral's Ygiene 206.
This regulatory approval represents the addition of a significant new weapon being deployed in the ongoing effort to combat healthcare-acquired infections (HAIs). HAIs account for a high number of illnesses each year, resulting in what could otherwise be avoidable fatalities. Coupled with appropriate infection control programs, Ygiene is expected to help reduce infections thereby not only potentially saving lives, but also redirecting scarce healthcare resources to overall improved medical care.
"The EPA's approval of BioNeutral's Ygiene disinfectant is very welcome news," says Tierno, director of clinical microbiologyÂ and immunology at New York University Langone Medical Center and clinical professor of microbiology and pathology at New York University School of Medicine. "Ygiene will now give hospitals a far more powerful, yet much safer alternative to bleach, and to fight the ever increasing array of super-bugs in their environment."
"We are all extremely pleased," says Kielbania. "This EPA approval is a milestone in the validation of our Ygiene technology and all of the various product lines it encompasses. We are now well positioned to proceed with vigor in making both of our complementary platforms Ogiene and Ygiene products available to all."Â