MOUNTAIN VIEW, CA — (Marketwired) — 04/29/13 — Hansen Medical, Inc. (NASDAQ: HNSN), a global leader in intravascular robotics, today announced that it will showcase its Sensei® X Robotic Catheter System with the new Artisan Extend® Catheter at the Heart Rhythm Society-s (HRS) 34th Annual Scientific Sessions from May 8-11, 2013 in Denver, CO. The Company will be exhibiting the Sensei X System at Booth 616.
Hansen Medical-s Artisan Extend Catheter includes a simplified flush design that can improve physician workflow during complex electrophysiology procedures, and allows for lower manufacturing costs. The Company completed a limited release of the new catheter in January, and it is now in full release in both the U.S. and Europe.
“We are encouraged by our growing EP business, as evidenced by the record procedures and catheter sales we delivered in 2012. We have experienced six consecutive quarters of procedure growth, and look forward to building on this positive momentum at HRS,” said Bruce Barclay, President and CEO of Hansen Medical. “Our record EP procedures and the greater than 10,000 clinical cases performed to date are a testament to the continued market adoption and clinical relevance of our Sensei X System and the value that it delivers to patients, physicians, hospitals, and payers. The initial clinical results from our Artisan Extend Catheter have been positive, which is important because the success of this catheter, as well as our Lynx® Ablation Catheter in Europe, are key elements of our EP business growth strategy.”
Other highlights of the HRS Scientific Sessions include:
Dr. Luigi Di Biase, Senior Researcher at the Texas Cardiac Arrhythmia Institute, will discuss his clinical experience with the Sensei X Robotic Catheter System in Room 304 on Thursday, May 9, from 12:55 pm – 1:15 pm.
Dr. Antonio Dello Russo, Cardiac Arrhythmia and Heart Failure Research Center, Catholic University of the Sacred Heart, San Camillo-Forlanini Hospital, Rome, Italy, will present multi-center research on robotic contact force sensing. The abstract will be displayed in the Exhibit Hall Thursday, May 9, from 2:00 pm – 5:00 pm.
Dr. Rahul Doshi from the University of California and Fullerton Cardiovascular Medical Group, will speak about the Sensei X Robotic Catheter System in Room 205 on Friday, May 10, 5:00 pm – 5:30 pm.
Dr. J. Michael Mangrum, Associate Professor of Medicine and Director of the Atrial Fibrillation Center at the University of Virginia, will present research on Endosense contact force sensing and the Sensei X Robotic Catheter System. The abstract will be displayed in the Exhibit Hall Friday, May 10, 2:00 pm – 5:00 pm.
More information about each of these Scientific Sessions may be found at .
Through continued advancement of medical robotics, Hansen Medical has developed a next generation minimally-invasive, robotic catheter system, the Sensei X Robotic Catheter System which combines advanced levels of 3D catheter control and 3D visualization. This unique, state of the art technology has been used in over 10,000 patients, and is powered by a robotically controlled arm that allows for catheter navigation, stability and positioning within the patient-s heart atria, allowing for the following system advantages:
Catheter Stability with Force-Sensing
Instinctive 3D Control
Reduced Fluoro Time for Physician
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, Magellan 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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