MOUNTAIN VIEW, CA--(Marketwire - November 30, 2010) - Hansen Medical, Inc. (NASDAQ: HNSN), a global leader in flexible robotics and the developer of robotic technology for accurate 3D control of catheter movement, today announced the opening of its new European headquarters in London that will serve as the hub for its commercial, training and physician support activities for its business outside the U.S., including the planned launch next year of the company's currently investigational flexible catheter vascular robotic system.
The London location, which is a short train ride from Heathrow Airport, was chosen because it is easily accessible from anywhere in Europe and is near several hospitals where the Hansen robotic technology is currently used in a growing number of procedures, noted Bruce Barclay, President and CEO of Hansen Medical. Both resident and visiting clinical support professionals and physicians will be able to use the training and product demonstration features at the new center.
Barclay commented, "Commercial execution does not begin and end with a robotic system purchase order. Both pre- and post-sale support and training are vital to adoption and, more importantly, the growing utilization of any new technology. Our ongoing programs in the EP lab, including the roll out of the Lynx™ ablation catheter in Europe, as well as the anticipated success of our flexible catheter vascular robotic system launch will be aided by this new center and our increased focus on customer and sales support."
Hansen Medical recently embarked on a limited European commercial rollout of its Lynx™ catheter, an innovative flexible, irrigated catheter that includes a proprietary therapy delivery system for the treatment of atrial arrhythmias, including atrial fibrillation.
"The new London center will make an excellent platform for increasing our international business," said Roland Peplinski, PhD, General Manager for EMEA, Asia Pacific and Canada. "Not only is the London facility easy to access for physicians from across Europe, but Hansen has multiple installed Sensei® robots in nearby hospitals, and so London has become a very active location for robotic ablation therapy. Our new center will give prospective physician partners a variety of training resources, from experienced mentors to technology resources unavailable anywhere else in Europe. We look to the London training center as a key element in our new commercial strategy."
The European center will serve as an important hub for the expected mid-2011 commercial launch of the company's currently investigational flexible catheter vascular robotic system. The vascular market is estimated to be more than 10 times the size of Hansen Medical's current addressable market and presents the company with a new set of physician customers. To that end, the company recently announced the successful completion of its First in Man Study which highlighted the potential of the vascular robotic system to improve the ability of physicians to safely, effectively and efficiently treat vascular disease while exposing the patient, physician and hospital staff to less radiation.
"The opening of this office is another important step in our plan to build on our growing presence in Europe and other countries outside the U.S., which is strategically significant for Hansen Medical in large part because of the anticipated 2011 commercialization of our currently investigational vascular robotic system," Barclay continued. "Our goal is to complement our talented sales team by offering a commercialization and training center that a customer or clinician anywhere in Europe can easily access in a day."
The 3,300-square-foot center is located on Eastbourne Terrace, directly across from Paddington Station in Central London.
About Hansen Medical, Inc.
Hansen Medical, Inc., based in Mountain View, California, develops products and technology using robotics for the accurate positioning, manipulation and control of catheters and catheter-based technologies. The company's Sensei® system and its Sensei X Robotic Catheter System were cleared by the U.S. Food and Drug Administration for manipulation and control of certain mapping catheters in electrophysiology (EP) procedures. This robotic catheter system is compatible with fluoroscopy, ultrasound, 3D surface map and patient electrocardiogram data. In the United States, the Sensei System is not approved for use in guiding ablation procedures; this use remains experimental. The U.S. product labeling therefore provides that the safety and effectiveness of the Sensei and Sensei X systems for use with cardiac ablation catheters in the treatment of cardiac arrhythmias, including atrial fibrillation (AF), have not been established during EP procedures, such as guiding catheters in the treatment of AF. In the European Union, the Sensei and the Sensei X systems are cleared for use during EP procedures, such as guiding catheters in the treatment of AF. The vascular robotic system requires regulatory filings and approval and is not commercially available. Additional information can be found at www.hansenmedical.com.
This press release contains forward-looking statements that involve risks, uncertainties, assumptions and other factors which, if they do not materialize or prove correct, could cause Hansen's results to differ materially from those expressed or implied by such forward-looking statements. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including statements containing the words "expected," "anticipated," "potential," "goal," "estimate" and similar words. Hansen Medical intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Exchange Act and the Private Securities Litigation Reform Act of 1995. Examples of such statements include statements about the expected timing of commercialization of our investigational vascular robotic system, expectations regarding effects on clinical procedures, effects of improved pre-and-post sales support, accessibility of our training center and success of the flexible catheter vascular robotic system launch. Important factors that could cause actual results to differ materially from those indicated by forward-looking statements include, among others, potential safety and regulatory issues that could delay, suspend or terminate clinical studies, regulatory approvals or sales, challenges in designing, engineering and manufacturing systems to function as intended, uncertain timelines, costs and results of clinical trials and development of new products, our ability to plan and manage cost-reduction or operational efficiency initiatives, the scope and validity of intellectual property rights applicable to products being developed, and our ability to remediate material weaknesses in internal controls over financial reporting. These and other risks are described in greater detail under the heading "Risk Factors" contained in our periodic SEC filings, including our Quarterly Report on Form 10-Q filed with the SEC on November 9, 2010. Given these uncertainties, you should not place undue reliance on the forward-looking statements in this press release. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available.
Hansen Medical, Heart Design, Hansen Medical & Heart Design, and Sensei are registered trademarks, and Artisan and Lynx, are trademarks of Hansen Medical, Inc. in the United States and other countries.