Singapore, Mar 11, 2009: Pasture Nanotechnology, a division of Pasture Pharma with activities in the R&D of bio-nanotechnology products received the Food and Drug Administration (FDA) approval for the use of its 2 respirators.
The respirators, intended for use by general public, can help reduce the user’s exposure to airborne germs during a public health medical emergency, such as an influenza or bird flu pandemic. Pasture Pharma, a Singapore based company is the second manufacturer in the world that has received FDA clearance for the specific use of such respirators in a public health emergency.
The new Pasture F550G and Pasture A520G respirators differ from the conventional NIOSH certified N95 respirators, which are meant only for occupational use and requires training and “fit testing” for employees. FDA’s approval process for the new respirators required Pasture Pharma to conduct clinical studies that show how these respirators fit “untrained” adults with a variety of facial sizes and contours. This is achieved by having users follow clear and comprehensive instructions provided for wearing the respirator, in order to meet standards of safety and effectiveness.
“When an influenza outbreak such as bird flu pandemic occurs, most people will not know which respirators (masks) to purchase or use to lower the risks of being infected. Not anymore! The development of, and now approval by FDA, of not just one, but two models of respirators, is a watershed for the company. More than it being the second in the world, it is a significant contribution to the health of the community in helping to reduce exposure to airborne germs” said Mr Lloyd Soong, CEO of Pasture Pharma Singapore.
“The Singapore Economic Development Board is greatly encouraged by the success of Pasture Pharma, as it represents a homegrown company that has made innovative use of a cutting edge nanotechnology and is doing well in the world market. As Singapore continues to build its technology capabilities, we look forward to companies such as Pasture Pharma developing novel and impactful applications,” said Mr Jonathan Kua, Director of the New Businesses Group at EDB.
Pasture Pharma has appointed a Tulsa-based company, chaired by the Former US Health and Human Services Secretary Mr Tommy Thompson, to represent its interests in North America. And it is in discussion with many distributors globally to make available the new respirators for consumer use in their respective countries.
In a report published in 2008, the US Institute of Medicine, the National Academy of Sciences, stated that the US alone requires 5.3 billion respirators for stockpile against pandemic influenza, but has only fulfilled 0.2% of it. In view of the current economic and financial situations, personal protection equipment (PPEs) like respirators are a more economical choice and stop-gap alternative, complimenting vaccines and drugs. Thus non-pharmaceuticals countermeasures are increasingly being considered.