Stereotaxis
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S-1/A
STEREOTAXIS, INC. filed this Form S-1/A on 06/17/2004
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including new magnet designs, catheter and guidewire designs, remote control systems, systems integration and automation and software development.

Overview of the Stereotaxis System

       Our proprietary Stereotaxis System provides the physician with precise remote digital instrument control through user friendly “point and click” and/or joystick-operated technology, which can be operated either from beside the patient table, as in traditional interventional procedures, or from a room adjacent to the patient and outside the x-ray fluoroscopy field. The NIOBE cardiology magnet system navigates disposable interventional devices to the treatment site through complex paths in the blood vessels and chambers of the heart to carry out treatment using computer controlled, externally applied magnetic fields to directly govern the motion of the working tip of these devices, each of which has a magnetically sensitive tip that predictably responds to magnetic fields generated by our system. Because the working tip of the disposable interventional device is directly controlled by these external magnetic fields, the physician has the same degree of control regardless of the number or type of turns, or the distance traveled, by the working tip to arrive at its position in the blood vessels or chambers of the heart, which results in highly precise digital control of the working tip of the disposable interventional device while still giving the physician the option to manually advance the catheter.

       Through our alliances with Siemens, Philips and J&J, this precise digital instrument control has been integrated with the visualization and information systems used during interventional cardiology and electrophysiology procedures in order to provide the physician with a fully-integrated and automated information and instrument control system. We have integrated our Stereotaxis System with Siemens’ digital x-ray fluoroscopy system, and we are in the process of integrating with Philips’ digital x-ray fluoroscopy system. In addition, we are integrating the Stereotaxis System with J&J’s 3D catheter location sensing technology, to provide accurate real-time information as to the 3D location of the working tip of the instrument, and with J&J’s ablation tip technology. We believe that the combination of these features will provide more effective instrument control and therapy delivery.

       Under the joint integration programs with each of Philips and J&J, we have completed the products definition phase, establishing detailed descriptions and technical specifications for the integrated products. We have established separate joint development teams with each of these collaboration partners, and the teams are working toward the implementation of the joint integrated product specifications and developing engineering, marketing and clinical programs. We expect the initial commercial introduction of Stereotaxis Systems integrated with J&J’s 3D catheter location sensing technology and with Philips’ digital x-ray fluoroscopy system to occur in 2005.

       The components of the Stereotaxis System are identified and described below:

 
Systems

       NIOBE Cardiology Magnet System. Our NIOBE cardiology magnet system utilizes two permanent magnets mounted on articulating or pivoting arms that are enclosed within a stationary housing, with one magnet on either side of the patient table, inside the cath lab. These magnets generate magnetic navigation fields that are less than 10% of the strength of fields typically generated by MRI equipment and therefore require significantly less shielding, and cause significantly less interference, than MRI equipment.

       NAVIGANT Advanced User Interface. The NAVIGANT advanced user interface is an integrated information and control center that consolidates the key information sources used by interventional cardiologists and electrophysiologists and allows these physicians to provide instrument control directions to precisely govern the motion of the working tip of disposable interventional devices.

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