"CRITERION'S loath to crow, but he's long maintained the most promising aspect of this one is its PolyNovo skin-repair arm, rather than its notorious peptide AOD9604.
Now PolyNovo's NovoPore foam dressing has won fast-track FDA assent, opening the way for the company to sell into a US market worth about $US300m ($334m) annually.
Aimed at treating bed sores, the topical negative-pressure dressing promotes skin regeneration by applying a vacuum through a dressing put in the wound cavity.
PolyNovo chief Laurent Fossaert says that, under the fast-track approval, PolyNovo only had to convince the regulator the product was just as effective as the existing device.
As it happens the incumbent product, KCI's GranuFoam, has been subject to FDA concerns about infection from residual foam fragments.
Fossaert says PolyNovo will pursue a distribution deal.
We had Calzada as a spec buy at 6.9c last July, when AOD9604 was embroiled in the Essendon Football Club's drugs saga.
We maintain the call in anticipation of real revenues from NovoPore and in the vague hope Calzada can extract value from AOD9604, which failed fat-busting trials but remains popular with body builders and sports scientists."
