Key Milestone Toward Expected Commercial Launch in Mid-2011
MOUNTAIN VIEW, CA, Oct 04, 2010 (MARKETWIRE via COMTEX) -- Hansen Medical, Inc. (NASDAQ: HNSN), the global leader in flexible robotics, today announced the completion of its First in Man Study, during which 20 peripheral endovascular procedures were successfully performed with the Company's new flexible catheter vascular robotic system. The vascular robotic system features a flexible catheter with remotely steerable distal tips designed to simplify and enhance catheter navigation and therapeutic intervention. The study demonstrated the potential of the system to improve the ability of physicians to safely, effectively and efficiently treat vascular disease -- while exposing the patient, physician and hospital staff to less radiation.
The 20 endovascular procedures, many of which included complex and diseased anatomy, were performed at the University Medical Centre in Ljubljana, Slovenia, by Borut Gersak, M.D., Ph.D, and Milenko Stankovich, M.D., from the University Medical Centre, and Alan Lumsden, M.D., and Jean Bismuth, M.D., from the DeBakey Heart & Vascular Center in Houston, Texas. Dr. Gersak and Dr. Lumsden are the study's principal investigators.
Dr. Lumsden noted that the Hansen Medical vascular robotic system's superior performance, even in complex and diseased anatomy, has the potential to standardize catheter navigation and make procedures safer and more predictable.
"The Hansen Medical vascular robotic system navigated safely and very efficiently through a variety of anatomies and lesions, including diffuse disease and chronic total occlusions," Dr. Lumsden said. "This technology required minimal learning curve for me and I believe it will allow for predictable navigation of complex anatomies. If combined with advanced imaging, such as 3D mapping and image fusion, the vascular robotic system has the potential to improve the way vascular surgeons and interventionalists perform endovascular procedures, by enabling precise multidimensional robotic control at the catheter tip. I am convinced this technology will empower physicians to perform safer, faster and more efficacious catheter interventions, while operating remotely, in a comfortable environment, free from harmful radiation."
Dr. Gersak added: "Based on these initial, successful patient outcomes, the Hansen Medical vascular robotic system has the potential to provide new capabilities to substantially simplify and enhance vascular procedures. Even in these challenging patients included in our initial cases, the vascular robotic system demonstrated the potential to take the complexity out of these procedures. The robotic sheath and leader catheter performed particularly well, and the control the robot provides at the catheter tip enables physicians to quickly and safely navigate difficult anatomy. Overall, these results show that the flexible robotic technology developed by Hansen Medical has the potential to improve the performance of interventionalists and other clinicians."
The results of these cases, which followed a successful pre-clinical study completed under the guidance of Dr. Lumsden and Dr. Bismuth, provide a key confirmation of the safety and technical efficacy of the new vascular robotic system. Prior pre-clinical studies published in the Journal of Vascular Surgery in April 2010 showed that flexible robotics from Hansen Medical has the potential to reduce procedure time by 80 percent and reduce the number of catheter movements per procedure, which may reduce the risk of dissection and embolization.
Dr. Bismuth said, "The First in Man Study has affirmed what we saw in our initial preclinical studies, which is that the Hansen Medical robotic system is able to navigate a variety of anatomy with great ease and safety, and has the potential to open the door to a new frontier in endovascular therapy."
In the U.S. the Company expects to seek approval from the U.S. Food and Drug Administration (FDA) for 510K clearance to market the system, and in Europe through the CE Mark process.
"Thanks to the hard work and dedication of many talented people our initial clinical study with the new vascular robotic system was very successful, and demonstrated significant potential of the system for endovascular procedures," said Hansen Medical President and CEO Bruce Barclay. "Successful completion of this key milestone is an important next step in the extension of our flexible robotics technology to the larger vascular market."
"The physician investigators and everyone at Hansen Medical are encouraged by these initial results because they demonstrate the potential value of our technology for millions of vascular patients around the world," continued Barclay. "Our entrance into the vascular market is a key strategic milestone for Hansen Medical as it is more than 10 times the size of our current addressable market and a new set of physician customers. Based upon this successful study, we expect, subject to regulatory approval, to be commercialized in the U.S. and Europe by this time next year."
The vascular market is large and rapidly growing, driven in large part by an aging population, the prevalence of diabetes and obesity and an increase in disease awareness. Of the more than 2 million vascular procedures done each year, approximately one-third to one-half of them are potentially addressable by Hansen Medical's vascular robotic system.
About Hansen Medical, Inc. Hansen Medical, Inc., based in Mountain View, California, develops products and technology using robotics for the accurate positioning, manipulation and control of catheters and catheter-based technologies. The company's Sensei(R) 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. The flexible robotic platform is compatible with fluoroscopy, ultrasound, 3D surface map and patient electrocardiogram data. 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. 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. Additional information can be found at www.hansenmedical.com.
Forward-Looking Statements This press release contains forward-looking statements. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including statements containing the words "plan," "expects," "believes," "goal," "estimate," and similar words. Hansen Medical intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Exchange Act and the Private Securities Litigation Reform Act of 1995. Examples of such statements include statements about the potential effects of our vascular robotic system on the vascular procedures and the timing of commercializing our vascular robotic system. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, among others, potential safety and regulatory issues that could delay, suspend or terminate future clinical studies or regulatory approvals, challenges in designing, engineering and manufacturing systems to function as intended, uncertain timelines, costs and results of clinical trials, and the scope and validity of intellectual property rights applicable to products being developed. These and other risks are described in greater detail under the heading "Risk Factors" contained in our periodic SEC filings, including our Quarterly Report on Form 10-Q filed with the SEC on August 6, 2010. 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.
Hansen Medical, Heart Design, Hansen Medical & Heart Design, and Sensei are registered trademarks of Hansen Medical, Inc. in the United States and other countries.
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SOURCE: Hansen Medical, Inc.