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Hansen Medical Announces First Ever Public Exhibit of Its Vascular Robotic System at Key European Meeting of Vascular Surgeons


March 31, 2011 - Mountain View, CA

Hansen Medical, Inc. (NASDAQ: HNSN), a global leader in flexible robotics and the developer of robotic technology for accurate 3D control of catheter movement, today announced it will exhibit its Vascular Robotic System at the 33rd Annual Charing Cross International Symposium from April 9-12 in London, U.K. The Company will be exhibiting its Vascular Robotic System at Stand 415.

"The Vascular Robotic System from Hansen Medical has the potential to improve the way endovascular treatments are performed," said Professor Nicholas Cheshire, M.D., of St. Mary's Hospital, part of the Imperial College Healthcare NHS Trust, in London, who has been pioneering the use of flexible robotics in vascular interventions. "Our research to date has shown the potential benefit of flexible robotics to enable new procedures, reduce endovascular procedure time and lessen radiation exposure. We are looking forward to gathering even greater clinical experience with the System once it becomes commercially available."

The Hansen Medical Vascular Robotic System is based upon the leading flexible robotic technology incorporated in the Sensei-X® Robotic Catheter System currently sold in the U.S. and Europe, and which has been used successfully in more than 5000 patients with cardiac arrhythmia, but with a number of key enhancements. First, the Vascular System allows for complete, individual robotic control of the distal tips of both the outer sheath and the inner leader catheter, as well as robotic manipulation of standard guidewires. Further, the catheter is expected to be available in multiple lengths and has a low profile with significant flexibility to be compatible with most 6F treatment catheters currently used today. Also, the System is designed to allow for sufficient extension inside the body to better access hard to reach peripheral anatomy. Finally, the System preserves the open architecture featured in the Sensei system to allow for the subsequent use with most therapeutic catheters on the market today. In 2010, the Company announced the completion of its First in Man study in Europe during which 20 endovascular procedures were successfully performed with an earlier version of the Vascular Robotic System, demonstrating its potential to improve the ability of physicians to safely, effectively and efficiently treat Peripheral Vascular Disease -- while exposing the patient, physician and hospital staff to less radiation. In Europe, the Vascular Robotic System requires CE mark and is not available for sale, nor can it be marketed until the CE mark is received. In the U.S., the System requires regulatory filings and approval and is not commercially available.

"We chose the 33rd Annual Charing Cross International Symposium for the initial public exhibition of our Vascular Robotic System because of the world class faculty and physicians expected to be in attendance," said Bruce J Barclay, President and CEO of Hansen Medical. "Many top physicians have been expressing interest in our development program, and giving the physicians attending the Symposium the chance to experience the System will provide us with additional feedback on its potential in their everyday practice. We are looking forward to exhibiting this new platform with vascular surgeons and interventionalists at this important Symposium."

Close by the Symposium in London is also the home of Hansen Medical's European headquarters and Education Centre and the hub for the commercial, training and physician support activities for its business outside the U.S. When the vascular system is available commercially, resident and visiting physicians and other clinical professionals will be able to use the training and product demonstration features at the Centre.

Barclay concluded, "We are planning an improved launch strategy from that used with the initial launch in the cardiovascular market. Pre- and post-sale support will be vital to adoption and growing utilization of our Vascular Robotic System and we are making those elements a high priority."

Other highlights of the Symposium include:

  • Professor Nick Cheshire and Dr. Celia Riga, Imperial College, London, will present "A New Robotic Endovascular Catheter Engineered for the Arterial Tree" on Sunday, April 10;
  • Professor Alan Lumsden and Dr. Jean Bismuth, the DeBakey Heart & Vascular Center, Methodist Hospital, Houston, Texas, will present "The Role of Simulators in Endovascular Training" also on Sunday, April 10; and
  • Professor Nick Cheshire will present "Steerable Catheters and Their Role in the Visceral Aortic Segment" on Monday, April 11.

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® 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. The flexible catheter vascular robotic system requires regulatory filings and approval and is not commercially available. 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," "potential," "believes," 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 benefits 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 Annual Report on Form 10-K filed with the SEC on March 16, 2011. 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 (Logo), Hansen Medical (with Heart Design), and Sensei are registered trademarks, and Artisan and Lynx are trademarks, of Hansen Medical, Inc. in the United States and other countries.

Investor Contacts:
Peter Osborne
Interim CFO
Hansen Medical
650.404.5800

Matt Clawson
Allen & Caron Inc
949.474.4300
Email Contact

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