Hansen Medical, Inc. (NASDAQ: HNSN), based in Mountain View, Calif, was founded in 2002 by Fred Moll, M.D., who was joined by Rob Younge and Dan Wallace as co-founders. The company’s initial public offering took place in November 2006. Today there are approximately 190 employees working for Hansen Medical.
The company was formed on the premise of developing a new generation of medical robotics for the accurate positioning, manipulation and stable control of catheters and catheterbased technologies during cardiac procedures. Hansen’s mission is to establish a standard of cardiovascular care by enabling a new class of percutaneous procedures using advanced, electromechanical technology. Electrophysiology (EP), the initial market to benefit from this new technology, includes procedures for the identification of abnormal heart beats in the upper chambers of the heart. It is estimated that approximately 160,000 of these procedures occur within the United States each year.
Hansen’s research and development has resulted in the new Sensei™ Robotic Catheter System and Artisan™ Control Catheter, designed to allow physicians to place mapping catheters in hard-to-reach anatomical locations within the heart easily and with stability during the diagnostic phase of cardiac arrhythmia treatment. Although the Sensei system is being developed initially for EP, there may be applications for the technology in catheter-based procedures outside of this market. Compatible with fluoroscopy, ultrasound, 3D surface map and patient electrocardiogram data, the new system is adaptable to any existing EP procedure room.
The Sensei system operates in conjunction with the Artisan catheter, which contains a through lumen to accommodate percutaneous catheters. The Artisan catheter is capable of movement with six degrees of freedom, which facilitates placement of percutaneous catheters in locations that are difficult to reach. The mobile workstation is placed away from direct radiation and allows the physician to remain seated throughout the procedure, which may reduce radiation exposure and operator fatigue.
Physicians who have used the Sensei System for EP procedures say the system has the potential to change the way cardiac procedures are performed to a more standard approach for complex diseases. Hansen Medical anticipates this proprietary technology will enhance the speed and safety of catheter-based procedures by offering physicians accurate and efficient control over catheter placement, which is difficult to achieve with existing manual interventional techniques. Additional information can be found at www.hansenmedical.com.
The open architecture provided by the Sensei System, which allows the use of pre-approved catheters from third-party manufacturers, requires a labeling addition from the FDA. The addition is intended to remind physicians that the safety and effectiveness of the system for use with cardiac ablation catheters in the treatment of cardiac arrhythmias, including atrial fibrillation, have not been established.
This backgrounder contains forward-looking statements that are subject to a number of risks and uncertainties, including statements about the potential for success and timing of sales in the United States and Europe of the Sensei System and Artisan Control Catheter. Actual results may differ materially from those set forth in this backgrounder due to the risks and uncertainties inherent in our business, including potential safety issues; the scope of potential use of our products; the scope and validity of intellectual rights applicable to our products; competition from other companies; our ability to obtain additional financing to support our operations; our ability to successfully launch and market our product; and other risks detailed in the “Risk Factors” contained in our periodic SEC filings, including our Annual Report on Form 10-K filed with the SEC on February 28, 2008. Given these uncertainties, you should not place undue reliance on these forward-looking statements. 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,” “Sensei,” ”Artisan,” ”Hansen Artisan,” as well as the Hansen Medical “heart design” logo are trademarks of Hansen Medical, Inc.
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