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part of the New Drug Application (NDA) process. In addition to this
clinical report, BioForm Medical's partner, Kreussler, is completing
manufacturing documentation for a newly expanded manufacturing
facility. The final manufacturing documentation is expected to be
completed and submitted to FDA before the end of calendar year 2008,
consistent with BioForm Medical's previously reported expected timeline
for completion of the NDA submission.
-- RELAXED EXPRESSIONS(TM): As previously announced on April 30, 2008,
BioForm Medical acquired from ACI a minimally invasive bi-polar
radiofrequency 510(k) medical device (renamed "Relaxed
Expressions(TM)") cleared to selectively reduce nerve function. The
Company has recently received an additional 510(k) clearance for a new
treatment profile software upgrade designed to improve outcomes of
procedures with the device. The Company has filed an Investigational
Device Exemption (IDE) with the FDA to conduct clinical studies
specifically intended to support an FDA application seeking clearance
to market this product for the treatment of frown lines. The Company
expects to also seek a CE Mark and certain other international
registrations of the Relaxed Expressions device for aesthetics
indications.
-- BIOGLUE Aesthetic(TM) Medical Adhesive: The Company and its partner,
CryoLife, Inc. announced in June 2008 the receipt of a CE Mark for
BioGlue Aesthetic(TM) Medical Adhesive for browplasties in Europe.
Pre-launch activities continue on a limited basis with early users, to
help the Company in its evaluation and development program to identify
and optimize uses of BioGlue Aesthetic adhesive. In the United States,
BioForm has completed a 30-patient
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| SOURCE BioForm Medical, Inc. Copyright©2008 PR Newswire. All rights reserved |