Prince Sultan Cardiac Center - Al Ahsa Represents Hansen Medical's First Sensei® X Robotic Catheter System Install in Middle East

Hospital Joins Growing List of Leading Global Heart Centers in Adopting Robotic Catheter Navigation

MOUNTAIN VIEW, CA--(Marketwire - June 13, 2012) - Hansen Medical, Inc. (NASDAQ: HNSN), a global leader in flexible robotics and the developer of robotic technology for accurate 3D control of catheter movement, and the Prince Sultan Cardiac Center - Al Ahsa (PSCCH), Kingdom of Saudi Arabia, today announced that PSCCH has become the first hospital in the Middle East to adopt the Sensei® X Robotic Catheter System for the treatment of cardiac arrhythmia.

"PSCCH's catchment area covers approximately 25 percent of Kingdom of Saudi Arabia, as well as neighboring Gulf nations," said Prof. Abdullah Alabdulgader, CEO and leading Electrophysiologist of PSCCH. "With life expectancy increasing in the region, the incidence of arrhythmia is increasing drastically. It is therefore important for our institution to make significant investments into our electrophysiology business line. This will enable us to deliver care to those patients who previously would have traveled to Europe or the United States in order to receive similar treatments."

"The adoption of robotic catheter navigation through the acquisition of the Sensei X is the cornerstone of our EP strategy," said Prof. Abdullah Alabdulgader. "Artisan's catheter stability, as well as the ability to know the contact force applied by the catheter tip on the heart wall, are major factors for us in adopting Hansen's intravascular robotic platform. As we complete our initial clinical cases, we are discovering additional benefits, such as reduced radiation and improved comfort for physicians during long EP procedures."

"Hansen Medical is honored that Prince Sultan Cardiac Center - Al Ahsa has chosen the Sensei X Robotic Catheter System as the cornerstone of their EP business strategy," said Bruce Barclay, Hansen Medical's President and CEO. "We continue to see increasing momentum in the adoption of the Sensei X Robotic Catheter System by electrophysiologists in the emerging markets, such as Prof. Abdullah Alabdulgader, who are eager to embrace new and innovative solutions in their EP laboratories so that their patients can receive the same level of high quality care which has previously been available only in leading heart centers in Europe and the United States."

"There is growing clinical evidence demonstrating the benefits derived from increased operator experience and the adoption of best practices with the Sensei X System, and it is important to replicate these successes in other centers through improved training and the sharing of best practices. As our company continues to improve our world class education and training program, more and more hospitals all over the world will be able to benefit from the extraordinary benefits provided by Hansen's flexible robotic technology," Barclay concluded.

 

About Sensei® X Robotic Catheter System
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 is powered by a highly accurate, robotically-controlled arm that allows for catheter navigation, stability and positioning within the patient's heart, allowing for the following system advantages:

·   Catheter Stability with Force-Sensing

·   Instinctive and Precise Catheter Placement Control

·   Reduced Radiation for Physician

 

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® 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 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 X System and Artisan Control Catheter for use with cardiac ablation catheters in the treatment of cardiac arrhythmias, including atrial fibrillation (AF), have not been established. In the European Union, the Sensei X System and Artisan Control Catheter are cleared for use during EP procedures, such as guiding catheters in the treatment of AF, and the Lynx® Robotic Ablation Catheter is cleared for the treatment of AF. 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.

 

Additional information can be found at www.hansenmedical.com.

 

Forward-Looking Statements
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," 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 on the vascular procedures and the timing and results of commercializing our Magellan Robotic System. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, among others: engineering, regulatory and sales challenges in developing new products and entering new markets; potential safety and regulatory issues that could slow or suspend our sales; the uncertain timelines, costs and results of pre-clinical and clinical trials; 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; the effect of credit, financial and economic conditions on capital spending by our potential customers; our ability to manage expenses and obtain additional financing; and other risks more fully described in the "Risk Factors" section of our Quarterly Report on Form 10-Q for the quarter ended March 31, 2012 filed with the SEC on May 7, 2012 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), and Sensei are registered trademarks, and Magellan is a trademark of Hansen Medical, Inc. in the United States and other countries.

 

Investor Contacts:
Peter J. Mariani
Chief Financial Officer
Hansen Medical, Inc.
650.404.5800

FTI Consulting, Inc.
Brian Ritchie
212.850.5683
brian.ritchie@fticonsulting.com

John Capodanno
212.850.5705
john.capodanno@fticonsulting.com

 

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