Fresh off of a $32 million funding round, Lombard Medical Technologies (LON:LMT) said it won pre-market approval from the FDA for the Aorflex delivery system used with its Aorfix stent graft for treating abdominal aortic aneurysms.
The British medical device company said it plans to use the cash to support the U.S. rollout of the Aorfix device.
The newly-minted product is designed to work with the Aorfix flexible stent graft, which won a PMA nod from the FDA in February. Lombard touts the stent as the only graft system in the U.S. indicated to treat challenging neck angulations from the range of 0°-90°.
"The recent funding allows the company to launch aggressively in the U.S., hiring 15 new reps to add to the 2 who were supporting clinical trials in the region," Canaccord Genuity analyst Julie Simmonds wrote in a note to investors. "These reps are to be sited in areas with the highest density of specialist EVAR hospitals. We expect expansion of the both the sales team and hospitals targeted in 2014 and 15."
"The approval of the accompanying Aorflex delivery system by the FDA is a tactically important achievement that will help ensure that clinicians deploy our stent graft most effectively," Lombard CEO Simon Hubbert said in prepared remarks. "This in turn should increase clinician adoption of Aorfix as the stent graft of choice, especially in patients with AAAs that present with more challenging anatomies."