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Hansen Medical and Philips Team up on Robotics for Invasive Procedures

HANSEN, a provider of flexible robotics and the developer of robotic technology for 3D control of catheter movement, announced it has entered into patent and technology license agreements, with Philips to allow them to develop and commercialize the non-robotic applications of Hansen Medical's Fiber Optic Shape Sensing and Localization (FOSSL) technology.

FOSSL is a disruptive visualization technology that employs a fiber optic sensor to allow physicians to identify both the shape and position of catheters and other tools used in invasive procedures.

The new catheter vascular robotic system is under development at Hansen Medical. Commercialization of the technology is planned in the U.S. and Europe in 2011, according to company officials. Hansen Medical will receive payments of $29 million in connection with these arrangements and will be eligible to receive up to an additional $78 million in future payments associated with the commercialization or licensing by Philips of products containing FOSSL technology.

The FOSSL technology enables efficient and precise control and continuous tracking of flexible tools used in these procedures. The technology will provide visual information in 3D with reduction in the use of x-ray. FOSSL is being developed by Hansen Medical and Luna Innovations, who are jointly advancing its use in medical applications.

As stated in the agreement, Philips has the exclusive right to develop and commercialize the FOSSL technology in the non-robotic vascular, endo-luminal and orthopedic fields. Both companies have amended their previous joint development agreement to allow Philips to increase certain fees to be paid by Hansen Medical based on the future sales of the currently investigational flexible catheter vascular robotic system.

“Today's announcement is an important milestone in the history of Hansen Medical,” said Bruce Barclay, president and CEO of Hansen Medical, in a statement. “As a result of the hard work by our talented employees, we have made tremendous strides evolving our business strategy and focusing on new market opportunities to create a proprietary mode of safe and effective imaging.”

According to Robert Mittendorff, vice president of Marketing and Business Development at Hansen Medical, the new agreements represented a considerable step forward in the relationship between Hansen Medical and Philips Healthcare in bringing innovative technology solutions to patients and physicians in multiple medical fields from orthopedics to interventional procedures.

FOSSL is a potentially disruptive visualization technology that employs a fiber optic sensor designed to allow physicians to identify both the shape and position of catheters and other tools used in minimally invasive procedures. FOSSL has the potential to enable more efficient and precise control and continuous tracking of flexible tools used in these procedures. Unlike traditional visualization methods, FOSSL is designed to provide visual information in 3D with significant reduction in the use of x-ray. FOSSL is being developed by Hansen Medical and Luna Innovations, Inc. which are jointly advancing its use in medical applications.

Under the terms of the agreements, Philips has the exclusive right to develop and commercialize the FOSSL technology in the non-robotic vascular, endo-luminal and orthopedic fields. In addition, the parties have amended their previous joint development agreement to allow for Philips to potentially extend and increase certain fees to be paid by Hansen Medical based on the future sales of the currently investigational flexible catheter vascular robotic system now under development at Hansen Medical with planned commercialization in the US and Europe in 2011. Hansen Medical will receive upfront payments of $29 million in connection with these arrangements and will be eligible to receive up to an additional $78 million in future payments associated with the successful commercialization or licensing by Philips or its collaborators of products containing FOSSL technology.

"Today's announcement is an important milestone in the history of Hansen Medical," said Bruce Barclay, President and CEO of Hansen Medical. "As a result of the hard work by our talented employees, we have made tremendous strides evolving our business strategy and focusing on new market opportunities to create a proprietary mode of safe and effective imaging. We are pleased to expand our relationship with Philips, and are now in a position to further develop and commercialize this technology which has the potential to improve clinical outcomes for future medical products, including to significantly reduce the amount of harmful radiation generated in interventional procedures, all to the benefit of patients, physicians and hospital staffs. Finally, these agreements allow us to significantly enhance our cash position and strengthen our balance sheet without incurring a dilutive event for our shareholders."

"These agreements represent a considerable step forward in the relationship between Hansen Medical and Philips Healthcare in bringing innovative technology solutions to patients and physicians in multiple medical fields from orthopedics to interventional procedures. We are delighted to be moving forward with Philips on both the application of the FOSSL technology outside of robotics and on the advancement of our robotics technology for vascular procedures," said Robert Mittendorff, M.D. Vice President of Marketing and Business Development at Hansen Medical.

While minimally invasive procedures have advanced significantly in the past 30 years, their potential is still limited by imaging and localization, which remain critical elements to knowing where flexible tools are in the body. Since the incision is so much smaller than typical open surgery and direct visualization is not possible, physicians have to rely on X-ray imaging or localization to know where their instruments are and the shape of the instruments they are manipulating. Significant radiation exposure to the patient and physician is often the result, and usually provides two dimensional information only. With FOSSL enabled devices, the potential benefits to patients and the physicians that treat them are substantial, including increased efficiency, control and reduced use of radiation in minimally invasive procedures.

Hansen Medical, Inc.'s Sensei® system and its Sensei X Robotic Catheter System 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 and Sensei X systems for use with cardiac ablation catheters in the treatment of cardiac arrhythmias, including atrial fibrillation (AF), have not been established during EP procedures, such as guiding catheters in the treatment of AF. In the European Union, the Sensei and the Sensei X systems are cleared for use during EP procedures, such as guiding catheters in the treatment of AF.

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