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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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