I believe that one doesn't need a (human) clinical trial for a Class II wound dressing. 3-D Matrix is being used in GI endoscopy, which is considered 'external'application that does not require an approval as a surgical hemostat. If 3-D can build a business with this indication, 3-D's users will eventually publish their experience in retrospective studies. Clinical experience and commercial history will trump published studies.
Both AC5 and Purastat may not be particularly effective in high volume, high prressure bleeds (AC5 was tested in a trial in a dermatology bleed with saline as a control; pretty weak) other reports are interesting but anecdotal. Bleeding encountered in GI endoscopy is a low flow, low preessure bleed. Both products would seem to be effective in this indication. There are millions of endoscopies annually, with andenomas and polyp removals which cause a little bleeding.
Point here is not to state that Purastat is better than AC5, or vice versa. Both products seem to be roughly equivalent (business reason for patent suit) in efficacy. Question is, Why is 3-D making a push forward and ARTH waiting? Has anyone seen the FDA cleared AC5 product commerce in the US? It was cleared by FDA in December.
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