SOURCE: Hansen Medical, Inc.

Hansen Medical, Inc.

October 30, 2014 08:30 ET

Hansen Medical Announces Global Launch of the Sensei X2® Robotic System

MOUNTAIN VIEW, CA--(Marketwired - Oct 30, 2014) - Hansen Medical, Inc. (NASDAQ: HNSN), a global leader in intravascular robotics, today announced the Sensei X2 Robotic System is commercially available in the U.S. and European Union. Sensei X2 is a technological leap forward; featuring faster processing speeds, enhanced image integration, and a lower profile design. Launch of Sensei X2 is a key milestone as Hansen continues to deliver on its pipeline of innovative robotic platforms for electrophysiology procedures.

"Sensei X2 incorporates insights from years of technical and clinical experience with the Sensei Robotic System in electrophysiology procedures," said Will Sutton, Hansen Medical's Chief Operating Officer. "With the growing body of evidence in over 26 clinical studies, we believe Sensei X2 will continue to aid electrophysiologists in improving patient outcomes."

"The introduction of the Sensei X2 Robotic System to the US and European markets demonstrates Hansen's commitment to electrophysiology," said Cary Vance, Hansen Medical President and Chief Executive Officer. "The advancements with Sensei X2 represent Hansen's ability to continually deliver on a robust, new product pipeline."

The Sensei X2 is the third generation Sensei system. The technology has been used in over 14,000 procedures. Sensei has also been the subject of 26 clinical studies, with data collected from more than 2,700 patients. Evidence confirms low complication rates, high average contact force, catheter stability, and reduced fluoroscopy time when compared with manual procedures.

The Sensei X2 Robotic System is an advanced technology used during electrophysiology procedures to remotely navigate a robotic catheter in the heart atria. Sensei technology offers catheter stability, accuracy, and access to hard-to-reach areas of the atria. Sensei's remote workstation integrates multiple imaging sources used by the physician during electrophysiology procedures. Use of Sensei has been demonstrated to reduce fluoroscopy radiation exposure during left atrial electrophysiology procedures.1

1. Kaplan, A. Three-Year Experience with the Robotic Catheter System. EP Lab Digest. May 2013.

About Sensei® Robotic Catheter System

Sensei Robotic System combines advanced levels of 3D catheter control and 3D visualization to remotely navigate a catheter for electrophysiology procedures. Sensei's robotically controlled arm allows for catheter navigation, stability and positioning within the patient's heart atria. This unique, state of the art technology has been used in over 14,000 patients and 26 studies with over 2,700 patients studied.

Indications for Use in the United States: The Hansen Medical Sensei® Robotic System and Accessories are intended to facilitate manipulation, positioning and control of Hansen Medical's robotically steerable catheters for collecting electrophysiological data within the heart atria with electro-anatomic mapping and recording systems, using the following percutaneous mapping catheters: the Polaris-Dx™ Steerable Diagnostic catheters made by Boston Scientific Corporation and the Livewire™ Electrophysiology catheters made by St. Jude Medical.

The safety and effectiveness of this device for use with cardiac ablation catheters, in the treatment of cardiac arrhythmias including atrial fibrillation, have not been established in the United States.

Indications for Use in the European Union: The Sensei® Robotic System, control catheters and accessories are intended to facilitate manipulation, precise positioning and control of percutaneous catheters within the atria of the heart.

About Hansen Medical, Inc.

Hansen Medical, Inc., based in Mountain View, California, is a 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, 9Fr Magellan™ Robotic Catheter, Magellan™ 6Fr Robotic Catheter, and related accessories are intended to facilitate navigation to anatomical targets in the peripheral vasculature and subsequently provide a conduit for manual placement of therapeutic devices. The Company's mission is to enable Cardiac Arrhythmia and Endovascular Procedures and to improve patient outcomes through the use of Intravascular Robotics. Additional information can be found at www.hansenmedical.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. 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 other 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 regarding the potential benefits of our robotic systems for hospitals, patients and physicians. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, among others: factors relating to engineering, regulatory, manufacturing, sales and customer service challenges in developing new products and entering new markets; potential safety and regulatory issues that could slow or suspend our sales; the effect of credit, financial and economic conditions on capital spending by our potential customers; the rate of adoption of our systems and the rate of use of our catheters; our ability to manage expenses and cash flow, and obtain adequate financing; and other risks more fully described in the "Risk Factors" in our annual report on Form 10-K for the year ended December 31, 2013, as updated from time to time by our quarterly reports on Form 10-Q and our other filings with the Securities and Exchange Commission. 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.

"Artisan Extend," "Hansen Medical," "Hansen Medical (with Heart Design)," "Heart Design (Logo)," "Sensei," "Lynx," "Artisan," "Instinctive Motion," "Fine Force Technology," "IntelliSense" are registered trademarks, and "Magellan" and "Hansen Medical Magellan" are trademarks of Hansen Medical, Inc. in the U.S. and other countries.