Message #23 From:
NewsBot Date: December 1, 2006 05:00:00 AM
EMFP News Emergency Filtration Products Issues Update on NanoMask(R) FDA and Australian TGA Process
HENDERSON, Nev.--(BUSINESS WIRE)--Emergency Filtration Products, Inc. (EFP) (OTCBB: EMFP) today issued the
following update concerning its 510k application for its NanoMask®
with the Food and Drug Administration (FDA).
In early September 2006, the company filed an application with the FDA
to have its NanoMask® classified as a Class
II, FXX, Surgical Mask. EFP received comments from the FDA and has been
working diligently to provide the agency with additional information.
The information requested by the FDA led EFP to conduct a battery of
additional tests concerning sensitivity, irritation and toxicity.
The company also had to develop testing protocols simulating the
aerosolization of challenge organisms to the mask and filters because
there were no previously existing protocols for nanotechnology-enhanced
filter media. EFP has already completed an initial series of efficacy
tests and is currently conducting further efficacy tests against
bacterial, viral and fungal challenges. Other tests that are planned to
be performed will address concerns about nanoparticle migration,
leaching, and product stability.
In Australia, EFP is complying with all information requests from the
Therapeutic Goods Administration (TGA) concerning the audit of the
NanoMask’s® Class I
medical device status.
“The FDA registration process has been
exacting, and we have been using our best efforts to comply with the
agency’s information requests,”
said Douglas K. Beplate, President and CEO, EFP. “While
there is no assurance that our NanoMask® will
be approved by the FDA, we are working through the process to build the
best possible case to have our NanoMask®
products classified as Class II, FXX.” Mr.
Beplate added, “In Australia, we expect to
supply the TGA in the near future with what we currently believe to be
the last informational request in seeking a successful review.”
EFP's nanoparticle-enhanced environmental mask, the NanoMask®
relies on the company's core 2H Technology™
filtration system, which utilizes a combination of hydrophobic and
hydrophilic filters able to capture, isolate and or eradicate bacterial
and viral microorganisms with efficiencies of 99.999%.
About Emergency Filtration Products, Inc.:
EFP is an air filtration products manufacturer whose patented 2H
Technology™
(http://emergencyfiltration.com/Technology/2HTechnology.htm) filter
system has produced filtration efficiencies of 'greater than 99.99%' at
a particulate size of 0.027 microns. EFP's initial products were
developed for the medical market: the Vapor
Isolation Valve™
(http://emergencyfiltration.com/Products/VIV.htm) and
RespAide®
(http://emergencyfiltration.com/Products/RespAide.htm) CPR Isolation
Mask used for resuscitation of respiratory/cardiac arrest cases; and 2H
Breathing Circuit Filter for ventilators, respirators and anesthesia
circuitry. Each has received FDA approval. The Company also markets an
Automated External Defibrillator Prep Kit featuring RespAide; and the
NanoMask®,
(http://emergencyfiltration.com/Products/NanoMask.htm) a nanotechnology
enhanced environmental mask. In addition to filtration products, the
company supplies Superstat®,
(http://emergencyfiltration.com/Products/Superstat.htm) a modified
hemostatic collagen, to the U.S. Military for surgery and extreme wound
care.
Safe Harbor Statement
This release may contain statements that are forward looking. Such
statements are made based upon current expectations that are subject to
risk and uncertainty. EFP does not undertake to update forward-looking
statements in this news release to reflect actual results of and changes
in assumptions or changes in other factors affecting such
forward-looking information. The actual future results of the company
could differ significantly from such forward-looking statements.
Specifically, approvals from the FDA and/or the TGA, if attained, may
not translate into significant sales of EFP's products. Sales may be
dependent on the success of future marketing campaigns, and both the
perceived need for EFP's products and the competitive performance of
such products in the marketplace.