Skinvisible's Patent Pending Hand Sanitizer Approval Extended for Ten Years
Skinvisible Prepares to Obtain Authorization for DermSafe® Through-out Europe
Las Vegas, NV– May 16, 2014 - Skinvisible Pharmaceuticals, Inc. (SKVI:OTCBB & OTCQB) has received notification from the Federal Public Service (FPS) Health, Food Chain Safety and Environment in Belgium that it has extended the registration of DermSafe, its unique antimicrobial hand sanitizer, for an additional ten years; until December 31, 2024. This replaces the previous authorization which was granted for only two years. DermSafe is regulated in accordance with Biocidal Product Regulation (EU) No. 528/2012. BPR regulates the marketing and use of biocidal products and has put into place regulations to improve the use and safety of biocidal products marketed by member states in the European Union.
DermSafe's approval in Belgium will act as the "Reference Member State" which will be leveraged for further authorization through-out Europe. This is a straight-forward process which involves notification in most countries. The entire EU authorization process is expected to be completed within five months.
"This extended authorization by the FPS in Belgium has provided Skinvisible with the opportunity to market DermSafe in Europe over a much greater period of time than previously granted", stated Mr. Terry Howlett, President and CEO. "We believe DermSafe is a product that can help prevent the spread of debilitating and fatal germs in hospitals, at home, at work and in the military and we are eager to make it available through-out Europe through distributors and licensees."
DermSafe is a non-alcohol hand sanitizer made with 4% chlorhexidine gluconate which has demonstrated persistent protection of both gram-negative and gram-positive bacteria and viruses through independent laboratory studies. Successful studies were performed against Methicillin-resistant Staphylococcus aureus (MRSA) and Escherichia coli (E. coli) as well as the Influenza A viruses H5N1 and H1N9. Skinvisible is currently investigating further testing of DermSafe against the (Middle East Respiratory Syndrome Coronavirus (MERS-CoV); a SARS-like virus and a new avian influenza A virus called H7N9.
DermSafe is currently available from Alto Pharmaceuticals in Canada. Skinvisible is seeking additional licensees in select territories for commercial and/or retail markets.