MOUNTAIN VIEW, CA — (Marketwire) — 10/28/11 — Hansen Medical, Inc. (NASDAQ: HNSN), a global leader in flexible catheter robotics and the developer of robotic technology for accurate 3D control of catheter movement, today announced that it will release its financial and operating results for the third quarter and nine months ended September 30, 2011 after market close on Wednesday, November 2, 2011.
Bruce Barclay, President and Chief Executive Officer, will host a conference call at 5:00 p.m. ET (2:00 p.m. PT) on November 2, 2011 to discuss the company-s results. The call may be accessed by dialing 877-941-2069 (480-629-9713 for international callers) and via the Internet in the Investor Relations section of Hansen Medical-s website at . Please go to the website at least 15 minutes early to register, download and install any necessary audio software. Following the call, a webcast replay will be available on Hansen Medical-s website, and an audio replay will also be available by calling 877-870-5176 (858-384-5517 for international callers) and entering the access code 4485113. The audio replay will be available through November 9, 2011.
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, the 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 conformity assessment and CE marking and are commercially available in the European Union. In the U.S., the Magellan Robotic System, the NorthStar Robotic Catheter and accessories are the subject of a current filing with the FDA and are not commercially available. Additional information can be found at .
This press release contains 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 “plan,” “potential,” “believes,” and similar words. Examples of such statements include statements about the potential benefits of our Sensei system in the treatment of patients, and statements about the potential benefits of our vascular robotic system on the vascular procedures and the timing of commercializing our vascular robotic system. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, among others, potential safety and regulatory issues that could delay, suspend or terminate future clinical studies or regulatory approvals, challenges in designing, engineering and manufacturing systems to function as intended, uncertain timelines, costs and results of clinical trials, and the scope and validity of intellectual property rights applicable to products being developed. 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 August 8, 2011. 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 of Hansen Medical, Inc. in the United States and other countries.
Peter J. Mariani
Chief Financial Officer
Hansen Medical, Inc.
650.404.5800
Sharrifah Al-Salem, CFA
415.293.4414
John Capodanno
212.850.5705
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