FDA Approves Supplemental Trial
Brian Marckx, CFA
On Tuesday (5/8/12)
announced that the FDA approved its IDE Supplement for an
additional clinical trial for dermaPACE. Aside from being
smaller than the than the initial 206-patient trial and also
incorporating treatment "boosts", the trials will be very
similar. The statistical methods (Bayesian) apply sequential
analysis allowing for the supplemental data to build on the
positive results from the initial larger study. Importantly,
the FDA typical approves Bayesian methods when there's already
compelling data to build upon (the totality of which will
presumably show statistical significance on the primary endpoint).
As we've noted previously, the pivotal trial data already indicated
dermaPACE was effective in healing diabetic foot ulcers - the
hurdle to clear hitting the primary endpoint (100% wound closure),
while not attained in the pivotal study, may very well be able to
cleared with additional dermaPACE treatments. Safety was also
excellent in the initial study, which was obviously a consideration
of the FDA in allowing for more aggressive (i.e. - treatment
"boosts") treatment with dermaPACE.
SANUWAVE believes the new trial can be completed (including data
analysis) in as early as 20 months following initiation.
Enrollment is projected at 90 patients (~45 treatment / ~45
control). Similar to the initial study, the treatment group
will receive four dermaPACE procedures during the first two
weeks. In order to improve on the efficacy from the initial
trial (which just missed statistical significance on the primary
endpoint) up to four treatment "boosts" can be delivered during
weeks four and ten. The primary endpoint, 100% wound closure
at week-12, will be the same. Assuming statistical
significance is met on the primary endpoint, the data will support
an amendment to SANUWAVE's existing PMA which could potentially
happen sometime in early-to-mid 2014 with FDA approval possible
before the end of that same year.
SANUWAVE hopes to initiate enrollment in the coming weeks.
They are currently finalizing selection of clinical sites and
getting IRB approvals. As we noted previously SANUWAVE will
also need to raise additional capital to fund the trial, which is
another prerequisite to full initiation of this study - which we
assume is also in the works.
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