Wednesday, June 18, 2014
QT Vascular
QT Vascular: CIMB discusses highlights from meetings and calls with various stakeholders. CIMB points out that FDA doesn’t “approve” medical devices, it “clears” them for sale. On average it takes around 5 months for FDA to review and clear a medical device 510(k) application.
On schedule of next wave of products, CIMB feels the “holy grail” is the drug coated/ eluting balloon (DEB) space. QTV’s drug coated Chocolate (DCC), its version of DEB is in the pipeline. CIMB suspects the FDA 510(k) application for DCC will be made as soon as 1Q15, meaning that QTV has a leg up in the coronary business, which is important as a growth element.
On M&A, Johnson & Johnson could be pressured to look hard at QTV to enter the DEB game as Medtronic-Covidien looks poised to take a big chunk of the DEB market as two of their DEB products targets FDA clearance and commercialization in the near future.
CIMB has a high conviction on QT Vascular with an Add rating with TP of $0.73
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