Hansen Medical, a California-based manufacturer of surgical robotics for the positioning, manipulation, and control of catheter, has won clearance from the U.S. Food and Drug Administration (FDA) for its smaller diameter Magellan 6Fr Robotic Catheter that’s used for peripheral vascular interventions.
The FDA clearance triggers the mandatory exercise of $14 million of Series A Warrants that were issued as part of the private placement of stock and warrants announced on July 31, 2013. The Company issued approximately 11 million Series A warrants with a per share exercise price of $1.23 as part of the private placement transaction.
Hansen’s Magellan catheters are part of its Magellan robotic surgery platform used during peripheral vascular interventions to provide navigation to anatomical targets and a conduit for manual device implantation while keeping physicians away from a potentially harmful radiation source. The Magellan 6Fr Robotic Catheter is the latest catheter with several advances, including dual-bend technology that allows in dependent robotic control of two separate bend sites on a single catheter.
Hansen is planning a limited release of the Magellan 6Fr Robotic Catheter in the coming months to collect clinical and procedure data, while a more wide-scale release will occur later in 2014.
Hansen stock soared 30 percent after receiving the clearance. Healthcare analyst Sean Williams of The Motley Fool says Hansen now has another product “to improve sales and reduce its cash burn rate.”
Williams continues, “recent growth in Hansen’s top line has been practically nonexistent, so the hope from shareholders is that this new product approval will help jump-start Hansen Medical back in the right direction again. As for me, while I appreciate the technology, I’m still lost as to how Hansen gets anywhere near profitability with its current lineup of products. In fact, with only $42 million in cash as of last quarter and a cash burn rate of $40 million annually, I’d be concerned about the potential for share dilution here. It’s a company I’d suggest safely monitoring from the sidelines.”
Hansen had accumulated a deficit of $340.8 million at the end of its September quarter. It lost $13.2 million on sales of $5 million. Hansen will release its financial and operating results for the fourth quarter and full year ended December 31, 2013 on Feb. 20, 2014.
Chris Lowe Named Interim CEO
Hansen also announced that Feb. 9, 2014 was Bruce Barclay’s last day as chief executive officer (CEO), a position he held since 2010. Current board member Chris Lowe has been named interim CEO.
Lowe has been with Hansen since 2006 when he came aboard as a director. The Board of Directors has retained Russell Reynolds Associates to conduct a search for a new CEO
“We thank Bruce for his many contributions to Hansen Medical. Bruce’s leadership has helped position the company as a leader in intravascular robotics,” said Mike Eagle, chairman of the Board of Directors. “The Board looks forward to supporting Chris and the management team through this transition.”