If we are to look at the application submitted to the FDA it...

If we are to look at the application submitted to the FDA it becomes quite apparent why cardiocel hasn’t been able to penetrate the market and why the share price has been declining over the last 6 months. Quite frankly its because it could be said that cardiocel is not materially different from its competitors.

CardioCel is manufactured from glutaraldehyde crosslinked bovine pericardium,
which is the same material used for the predicate devices. CardioCel is considered to
be substantially equivalent to the predicates for the following reasons:
* Same raw material.
" Same intended use.
" Used in the same patient population.
" Used in the same clinical environment.
" Manufactured using the same principles of crosslinking with glutaraldehyde.
* Used in the same anatomical region (cardiovascular system).
" Intended to perform as a long term implant, maintaining the integrity of the
area repaired.
* Operates using the same fundamental scientific technology.
* Supplied in several sizes.
" Similar manufacturing process
* Similar sterilisation method to one predicate.
* Similar packaging and labelling

I’m up in the air as far as HSV2 vaccine goes who knows there's been many an attempt to create this kind of vaccine without success.

http://www.accessdata.fda.gov/cdrh_docs/pdf13/k130872.pdf