Hansen Medical (Hansen Medical) Risk Assessment

Hansen Medical Inc, formerly known as AutoCath Inc, was incorporated in Delaware in 2002. The Company completed its initial public offering on February 28, 2014. The Company develops, manufactures and sells medical robotics designed for accurate positioning, manipulation and stable control of catheters and catheter-based technologies. Its products include Sensei Robotic Catheter System, Magellan Robotic System, Artisan catheter, Lynx catheter, Magellan Robotic Catheter, and CoHesion 3D Visualization Module. Sensei Robotic Catheter System, or Sensei system, is designed to allow physicians to navigate flexible catheters with solid stability and control in interventional procedures within the atrial heart chambers. This system enables physicians to direct the movements of a robotic catheter like the Company's Artisan Control Catheter and Artisan Extend Control Catheter, or Artisan catheters, and Lynx Robotic Ablation Catheter, or Lynx catheter, to an anatomical location. The Sensei system is comprised of two modules: a physician control console and a patient-side module that can be connected to procedure tables. The control console can be located inside the Electro-Physiology Laboratory, or EP lab, and close to the patient or outside the EP lab in a separate location shielded from radiation. The Company's Magellan Robotic System is a peripheral vascular interventional platform that, used in combination with the Magellan Robotic Catheters, has the potential to provide endovascular specialists with vessel navigation, catheter stability during the manual delivery and placement of therapeutic devices, reduced procedural radiation exposure and fatigue, and precise robotic control of distal catheter tips. Magellan Robotic System is comprised of two modules: a physician control console and a patient-side robotic arm that can be connected to procedure tables. The Artisan catheter is a disposable catheter and guide catheter assembly that consists of a telescoping set of control catheters that are integrated to provide the desired motion of the tip of a diagnostic or therapeutic catheter that is inserted through the center lumen of the Artisan catheter. This is designed to accurately control the movement of a third party catheter chosen by the physician. CoHesion 3D Visualization Module, or CoHesion Module, is a software interface between Sensei system and the St. Jude Medical EnSite System for EP procedures. It is designed to provide physicians with 3D visualization to augment their ability to move a catheter throughout the atria, as well as increase control over placement of the catheter in specific locations. The Company markets, sells and supports its products in the United States through a direct sales force of regional sales employees, supported by clinical account managers who provide training, clinical support and other services to customers. Outside the United States, in the European Union, it uses a combination of a direct sales for