FDA Approves Supplemental Trial - Analyst Blog


FDA Approves Supplemental Trial

Brian Marckx, CFA

On Tuesday (5/8/12) SANUWAVE ( SNWV ) 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.

We cover SANUWAVE with an Outperform rating and $2.00/share price target.   

To view a free copy of our most recent research report on SNWV or subscribe to our daily morning email alert, visit Ken Nagy's coverage page at http://scr.zacks.com/ .


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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of The NASDAQ OMX Group, Inc.

This article appears in: Investing , Business , Stocks

Referenced Stocks: SNWV



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