SOURCE: Emergency Filtration Products, Inc.
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September 28, 2007 06:00 ET
Emergency Filtration Products Issues FDA Update
LAS VEGAS, NV--(Marketwire - September 28, 2007) - Emergency Filtration Products, Inc. (EFP)
(PINKSHEETS: EMFP) today announced that it has withdrawn the Company's
510(k) notification (510(k)) for its NanoMask product from current FDA
review. EFP originally filed its initial 510(k) in 2006. The FDA review
had been suspended pending EFP response to various FDA requests for
additional information, some of which required the company to commission
additional scientific testing. The deadline for responding to the FDA
requests is October 5, 2007. However, EFP learned recently that the
required testing will not be completed by that time.
EFP management believes that the company has made substantial progress in
2007 toward completing all of the additional scientific testing necessary
to respond to the FDA information request. EFP in conjunction with Applied
Nanoscience Inc. (ANI) (PINKSHEETS: APNN), the company with which EFP has
announced a merger, has initiated all required testing and analyses. EFP
has also retained well-known scientific and medical experts to ensure
thorough scientific response to the FDA's information request. ANI has
been assisting the funding of the ongoing testing and expects to continue
to assist funding EFP to enable EFP to finalize the required testing in
order to resubmit a 510(k) notification.
EFP intends to submit a new 510(k) notification as soon as the company is
satisfied that all of the information requested by FDA staff is available
and is scientifically sound. The schedule for completion of all required
testing and preparation of a new FDA notification is imprecise due to the
nature of the testing required. However, management currently estimates
that a complete new 510(k) notification will be ready for submission to FDA
around the middle of December.
"EFP's initial 510(k) submission to the FDA, which was made by the
Company's former management, gave rise to significant comments by the FDA,"
said Philip Dascher, CEO, EFP. "As a result, EFP, in tandem with ANI, had
to develop new testing protocols and perform testing at independent
laboratories in order to satisfactorily answer the FDA's comments. Since
we are braving new ground, working with emerging technologies, we have had
to originate new ways of testing our product -- which have been reviewed by
the FDA -- in order to verify its safety and effectiveness. This process
has taken considerably more time than originally anticipated, but we expect
to complete our testing and file a new 510(k) with the FDA before the end
of the year if possible. Obviously, we want to complete the current
testing and file our new FDA notification as soon as we possibly can.
However, we will not rush this filing or the underlying scientific testing
and analyses. We will file again with FDA just as soon as we are confident
that we can provide all of the information they requested with a first-rate
scientific basis."
For further information about Emergency Filtration Products, please visit:
www.emergencyfiltration.com
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 and AN do 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 plans and results of the companies could
differ significantly from such forward-looking statements.