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BioForm Reports Financial Results for the Fourth Quarter and Full Fiscal Year Ended June 30, 2008
Date:9/4/2008

er and reticular veins, have been submitted to FDA as

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

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