California surgical robotics maker Hansen Medical (NSDQ:HNSN) won FDA clearance for a smaller version of its Magellan catheter for use in peripheral vascular interventions.
HNSN stock soared on the news, rising 20.2% to $2.68 as of about 12:40 p.m. today.
The FDA win trigged the mandatory exercise of $14 million in Series A warrants that were issued in July 2013 in a private placement funding round, Hansen reported. The company further issued $11 million in Series B warrants priced at $1.50 apiece and Series C warrants at $2 apiece, both due in August 2015 and not subject to mandatory exercise.
Hansen’s Magellan catheters are part of the Magellan robotic surgery platform, which in June 2012 won FDA clearance for use during peripheral vascular interventions, providing navigation to anatomical targets and a conduit for manual device implantation while keeping physicians away from a potentially harmful radiation source.
The newly cleared Magellan 6Fr features 2 independent bend sites in a single catheter, compared with the 9Fr version’s use of 2 independently controlled catheters. Hansen initiated a limited launch of the 6Fr catheter, expecting to begin wider distribution later this year.
The Magellan system has applications for use by interventionalists, cardiologists, radiologists and endovascular surgeons, according to Hansen, and many of the centers performing peripheral vascular interventions today have also bought into Intuitive Surgical’s (NSDQ:ISRG) da Vinci robot-assisted surgery system.
Hansen has faced some recent legal turmoil amid an SEC investigation of former senior vice president Christopher Sells, accused of participating in a scheme to artificially inflate sales figures, and an $8.5 million settlement tied to a shareholder lawsuit over the company’s 2009 financial restatement.
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