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Posted: November 17, 2009
American Biotech Labs Receives FDA Clearance for New Prescription Wound Dressing Gel
(Nanowerk News) American Biotech Labs, LLC (ABL), developer of a new class of products based on the company's patented nano-catalytic SilverSol Technology®, today announced that the company has obtained clearance by the U.S. Food and Drug Administration (FDA) to market its ASAP Antibacterial Silver Wound Dressing Gel as a prescription 510(k) medical device throughout the United States. Clifton Mining Company is a major shareholder in American Biotech Labs.
The FDA 510(k) medical device clearance enables ABL to market its ASAP Antibacterial Silver Gel "for use in the management of 1st and 2nd degree burns, stasis ulcers, pressure ulcers, diabetic ulcers, lacerations, abrasions, skin tears, surgical incision sites, device insertion site wounds, graft sites and donor sites." In addition, according to the draft package insert, the new product "has in laboratory tests been shown to inhibit the growth of microorganisms such as (Staph...E. coli...MRSA and VRE as well as fungi such as Candida albicans."
The product utilizes ABL's innovative SilverSol Technology®, which has garnered multiple patents in the U.S. and several countries throughout the world, including a broad-use patent that provides the company with exclusive rights to use its silver-based products to combat many of the world's most destructive pathogens. ABL has performed extensive anti-microbial studies against bacteria, yeast, fungus and other pathogens. Information about these studies is available at research section of the ABL Website, www.americanbiotechlabs.com/researchprotected/researchmenu.html.
"The FDA's decision to grant clearance for the ASAP Antibacterial Silver Wound Dressing Gel as a prescription device is an extraordinary validation for our company and its patented processes and uses," said Dr. William Moeller, a Managing Director of American Biotech Labs. "This is a major step forward in our mission of using our products to improve lives by combating many of the world's most deadly pathogens."
This is the second ABL product to obtain FDA clearance; in April the company's ASAP Wound Dressing Gel received clearance as a 510(k) over-the-counter medical device.
About American Biotech Labs
American Biotech Labs, founded in 1998, utilizes patented processes and SilverSol Technology® to create singularly powerful and effective nano-catalytic silver products. In extensive testing performed by a variety of respected laboratories and researchers, ABL's silver hydrosol has consistently demonstrated the ability, without any known toxic side effects, to destroy a wide range of bacteria, viruses, yeast, and molds. ABL products have been approved by the Environmental Protection Agency (EPA) as a disinfectant for dental water lines, and as a surface disinfectant for bacteria, yeast and mold in hospital, residential, commercial and industrial settings; and has been cleared by the U.S. Food and Drug Administration (FDA) for wound care. The company's products have been the subject of multiple peer-reviewed articles in professional journals. The company's products are sold worldwide as EPA approved disinfectants, FDA cleared wound care products, cosmetics, and also supplements. The supplement and cosmetic products are sold nationally at health food stores and by medical professionals under the Silver Biotics® and ASAP Solution® brands, and through a variety of private labels.