Perhaps Cytori Therapeutics (CYTX - Get Report) is the best proxy for making an educated guess about how well Mela will perform commercially in Europe. Cytori has a CE Mark for its Celution System device, which extracts stem cells from fat tissue for use in reconstructive surgery. Cytori has not been able to gain FDA approval for Celution System, however, because the company hasn't yet conducted the clinical trials FDA requires.
Cytori has convinced a smattering of European cosmetic surgeons to purchase and use Celution System, but nowhere near the levels required to make Europe a profitable business opportunity.
Mela lacks the infrastructure, expertise and funds to sell an unproven medical device in Europe. My best guess is that Mela, just like Cytori, will find it difficult to generate significant revenue in Europe. I see no reason to change my bearish fundamental view of the company and its stock.
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