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

number of ongoing programs evaluating new forms, applications and

indications of its patent protected RADIESSE dermal filler technology.

The first new commercial product derived from these efforts is expected

to be a form of RADIESSE dermal filler with Lidocaine which may improve

comfort for patients and flow characteristics for physicians, and is

expected to be launched in the United States and Europe in calendar

year 2009.

-- RADIESSE(R) Dermal Filler Post-Market Studies: The Company has

completed and submitted to FDA the results of two post-approval studies

for RADIESSE filler -- a three-year post-approval open-label follow-up

to the pivotal nasolabial fold study to evaluate the long-term safety

and duration of effect with RADIESSE filler, and a study to assess the

safety of RADIESSE dermal filler in nasolabial folds in persons of

color. In the three-year study in nasolabial folds, more than 30% of

treated nasolabial folds were rated by the treating investigator as

improved in patients who were two to three years from their last

injection. No long-term product related adverse events or

delayed-onset adverse events were reported in the study. In the

persons of color study, observed adverse events were typical of dermal

fillers such as redness, swelling, and bruising, and the study found

that RADIESSE dermal filler is safe for use in persons of color. These

studies were conducted pursuant to the requirements of the FDA

associated with the approval for RADIESSE dermal filler for facial

folds and wrinkles.

-- POLIDOCANOL: As announced in a separate press release today, positive

results from the Phase III clinical trial of Polidocanol (European

trade name Aethoxysklerol(R)), a sclerotherapy product for the

treatment of spid
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SOURCE BioForm Medical, Inc.
Copyright©2008 PR Newswire.
All rights reserved

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