Hansen Medical, Inc. (NASDAQ: HNSN)
Corporate Headquarters:
800 E Middlefield Rd.
Mountain View, Calif., 94043
650.404.5800
www.hansenmedical.com
§European Subsidiary:
Hansen Medical UK Ltd.
30 Eastbourne Terrace
Paddington, London
W2 6LE United Kingdom
+44 207 393 1900
Founded: 2002
IPO: November 2006
Business Objective: Hansen Medical, Inc. (NASDAQ: HNSN) was founded in 2002 to develop products and technology using robotics for the accurate positioning, manipulation and stable control of catheters and catheter-based technologies.
Total Number of Employees as of July 1, 2011: Approximately 175
Products and Intended Use:
The Magellan™ Robotic System: The Magellan Robotic System and the NorthStar™ Robotic Catheter were created to improve the ability of physicians to efficiently perform endovascular procedures, and to enable new procedures, while exposing the physician to less radiation. The system will enable remote and predictable manipulation of low-profile robotically steerable catheters. The catheters are designed to simplify catheter navigation and therapeutic intervention with minimal learning curve. The Magellan system was CE Marked in the European Union in July 2011 and received FDA clearance in June 2012. The indication for use is to facilitate navigation to anatomical targets in the peripheral vasculature and subsequently provide a conduit for manual placement of therapeutic devices.
The Sensei® X Robotic System: The Sensei X Robotic Catheter System and Artisan® Control Catheter allow physicians to instinctively navigate flexible catheters with great stability and control during interventional procedures. The Sensei X system was cleared by the US FDA and CE Marked in 2009 for manipulation and control of certain mapping catheters in electrophysiology (EP) procedures. The Sensei system was cleared by the US FDA and CE Marked in 2007 for use during EP procedures, such as guiding catheters in the treatment of atrial fibrillation.
Media Resource:
Bruce J Barclay, president and CEO
Hansen Medical
The safety and effectiveness of the Sensei® X Robotic Catheter System for use with cardiac ablation catheters in the treatment of cardiac arrhythmias, including atrial fibrillation, have not been established.
The NorthStar™ Robotic Catheter - Not yet CE marked.
Magellan™ Robotic System and NorthStar™ Robotic Catheter - 510(k) Pending. Not available for sale in the U.S.
Forward-Looking Statements
This fact sheet 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 forwardlooking 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.
Media and Investor Contacts:
Brian Ritchie
212.850.5683
brian.ritchie@fticonsulting.com
John Capodanno
212-850-5705
john.capodanno@fticonsulting.com
www.hansenmedical.com/investor-relations/...tor-fact-sheet.php