M&A status: A juicy target in 2013. Canaccord Genuity analyst Jason Mills and others predicted previously that HeartWare International ($HTWR) was ripe for M&A activity, having gained a CE mark for its ventricular assist system. That hasn't happened yet. But analysts such as Matt Dolan of Roth Capital Partners say the company remains desirable. Earlier in 2012, HeartWare gained expanded European approval for its ventricular assist system. In the U.S., HeartWare is full speed ahead with clinical trials testing the device as both a bridge-to-transplant and destination therapy. The company is confident enough in gaining PMA approval that it boosted spending in the 2012 third quarter to ramp up corporate infrastructure and expand operations so it will be ready. An FDA panel of experts in April 2012 already voted to support the device, which bodes well for a PMA signoff. More than 2,500 patients have successfully received the company's ventricular assist system so far, HeartWare notes.
Likely acquirers: Rival Thoratec ($THOR) tried and failed to buy the company in 2009 after the FTC challenged the deal. Could Thoratec try again? It is not out of the question that Thoratec might take another shot at merging to strengthen its long-term prospects. But Thoratec itself is thought to be an acquisition target this time. Some of the major device companies could step in and bid this time around, seeking to gain a chunk of the ventricular pump market that could surpass $700 million in the U.S. alone, Mills told Bloomberg.
HeartWare Q3 losses rise, but so do EU HVAD sales
HeartWare's HVAD implant wins expanded European approval
FDA panel widely supports HeartWare's LVAD
Analysts: Medical device M&A will heat up in 2013