MOUNTAIN VIEW, CA — (Marketwired) — 04/08/13 — Hansen Medical, Inc. (NASDAQ: HNSN), a global leader in intravascular robotics, today announced that its Magellan Robotic System was featured in broadcast on the French national news on Sunday, April 7. The robotic procedure included in the broadcast, a contralateral approach to a left iliac lesion, was successfully performed at Hôpital Civil Strasbourg in Strasbourg, France by Professor Nabil Chakfé, M.D. A link to the broadcast is available in the “Investor Relations” section of Hansen Medical-s website at or may be found at .
“We are very pleased to receive the increased visibility in France afforded by this national news segment featuring our Magellan Robotic System,” said Bruce Barclay, President and CEO of Hansen Medical. “Our Magellan Robotic System has been installed at Hôpital Civil Strasbourg since November 2012 and has been utilized in numerous successful cases since that time. We have a large and growing pipeline of clinical interest in our robotic technology, and cases such as the one performed by Professor Chakfé provide additional opportunities for clinicians and patients worldwide to view the significant benefits provided by the Magellan System.”
“The procedure culminated with a successful patient outcome and a positive experience for the physicians and hospital staff,” said Professor Chakfé. “This case helped to further demonstrate the real-world medical utility of Hansen Medical-s robotic catheters and how the Magellan Robotic System can significantly enhance endovascular procedures.”
Hansen Medical-s Magellan Robotic System is based upon the flexible robotic technology incorporated in the Sensei-X® Robotic Catheter System currently sold in the U.S. and Europe, which has been used in over 10,000 patients, but includes a number of key enhancements. In particular, the Magellan Robotic System:
Provides solid catheter stability for placement of therapeutic devices.
Is designed to enable predictable procedure times and increased case throughput.
Allows for independent, individual robotic control of the distal tips of both the outer sheath and the inner leader catheter, as well as robotic manipulation of standard guidewires.
Is designed to allow for sufficient extension inside the body to access hard to reach peripheral anatomy.
Preserves the open architecture featured in the Sensei System to allow for the subsequent use of many 6F therapeutic devices on the market today.
Is designed to potentially reduce physician radiation exposure and fatigue by employing a remote physician workstation.
Hansen Medical, Inc., based in Mountain View, California, is the global leader in intravascular robotics, developing products and technology designed to enable the accurate positioning, manipulation and control of catheters and catheter-based technologies. The Company-s Magellan Robotic System, NorthStar Robotic Catheter and related accessories, which are intended to facilitate navigation to anatomical targets in the peripheral vasculature and subsequently provide a conduit for manual placement of therapeutic devices, have undergone both CE marking and 510(k) clearance and are commercially available in the European Union, and the U.S. In the European Union, the Company-s Sensei® X Robotic Catheter System and Artisan Control Catheter are cleared for use during electrophysiology (EP) procedures, such as guiding catheters in the treatment of atrial fibrillation (AF), and the Lynx® Robotic Ablation Catheter is cleared for the treatment of AF. This robotic catheter system is compatible with fluoroscopy, ultrasound, 3D surface map and patient electrocardiogram data. In the U.S. the Company-s Sensei X Robotic Catheter System and Artisan Control Catheter were cleared by the U.S. Food and Drug Administration for manipulation and control of certain mapping catheters in EP procedures. 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 X System and Artisan Control Catheter for use with cardiac ablation catheters in the treatment of cardiac arrhythmias, including AF, have not been established. Additional information can be found at .
This press release contains forward-looking statements regarding, among other things, statements relating to goals, plans, objectives, milestones and future events. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including statements containing the words “plan,” “expects,” “potential,” “believes,” “goal,” “estimate,” “anticipates,” and similar words. These statements are based on the current estimates and assumptions of our management as of the date of this press release and are subject to risks, uncertainties, changes in circumstances and other factors that may cause actual results to differ materially from the information expressed or implied by forward-looking statements made in this press release. Examples of such statements include statements about the potential benefits of our Magellan Robotic System for hospitals, patients and physicians, expectations of shipments and installations of our robotic systems, catheter sales, and procedures, expectations of gross margins and operating expenses for 2013, the sufficiency of the company-s cash resources for supporting the Company-s operations, expected efficiencies from cost saving initiatives, and the anticipated timing of commercially launching a 6F vascular catheter. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, among others: engineering, regulatory, manufacturing, sales and customer service challenges in developing new products and entering new markets; the commercial viability of our products in the vascular markets; potential safety and regulatory issues that could slow or suspend our sales; the effect of economic conditions on capital spending by our potential customers; the uncertain timelines for the sales cycle for newly introduced products; the rate of adoption of our systems and the rate of use of our catheters; the scope and validity of intellectual property rights applicable to our products; competition from other companies; our ability to recruit and retain key personnel; our ability to maintain our remedial actions over previously reported material weaknesses in internal controls over financial reporting; our ability to manage expenses and cash flow, and obtain additional financing; and other risks more fully described in the “Risk Factors” section of our Annual Report on Form 10-K for the year ended December 31, 2012 filed with the SEC on March 18, 2013 and the risks discussed in our other reports filed with the SEC. 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 (Logo), Hansen Medical (with Heart Design), Sensei and Lynx are registered trademarks, and Magellan and NorthStar are trademarks of Hansen Medical, Inc. in the United States and other countries.
Peter J. Mariani
Chief Financial Officer
Hansen Medical, Inc.
650.404.5800
Brian Ritchie
212.850.5683
John Capodanno
212.850.5705
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