There seem to be several misconceptions or maybe just different opinions about the ability for Cytori to protect the IP, which went into the designing- and engineering of the Celution range of products. Thereto different opinions about the technical superiority of the same system. I do not think the following write-up will eliminate differences of opinion, but provides sufficient additional information to provide a clearer picture.
Presently we have the Celution 700 system designed specially for the US- this in respect of the clarity to convey the individual "approved" predicate devices- is awaiting FDA approval still.
The FDA 510K application was filed several times- the approval denied as many times, but those decisions were appealed and are going in front of a court in April 2012, which is NOT FDA prejudiced.