SOURCE: Hansen Medical, Inc.

Hansen Medical, Inc.

November 10, 2010 16:01 ET

Hansen Medical's Investigational Flexible Catheter Vascular Robotic System to Be Presented at International Symposium

37th Annual VEITHsymposium™ of Vascular Surgeons and Interventionalists Sponsored by Cleveland Clinic

MOUNTAIN VIEW, CA--(Marketwire - November 10, 2010) - 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 that its investigational flexible catheter vascular robotic system, including an overview of its preclinical evaluation and the recently completed First in Man study, will be presented at the upcoming 37th annual VEITHsymposium™ November 17-21 at the Hilton New York in New York City.

"This five-day annual symposium is one of the year's most important gatherings of vascular surgeons and interventionalists from around the world. Based on the initial clinical work, I believe our robotic system has the potential to standardize catheter navigation," said Bruce Barclay, president and CEO of Hansen Medical. "The expected regulatory submission, clearance and commercialization of our vascular robotic technology next year is a critical element to our overall business strategy, and this conference allows the progress made to be shared with many of the world's foremost clinicians and thought leaders in the vascular surgery and interventional community."

The presenters will include the clinicians that conducted the First in Man Study, including Alan Lumsden, M.D., and Jean Bismuth, M.D., of the DeBakey Heart & Vascular Center in Houston, Texas; and Borut Gersak, M.D., Ph.D., and Milenko Stankovic, M.D., of the University Medical Centre, Ljubljana, Slovenia. Professor Gersak and Professor Lumsden were the study's principal investigators. The presenters will also include Nick Cheshire, M.D., and Celia Riga, MB BS, BSc, MRCS (Eng), of St. Mary's Hospital, part of the Imperial College Healthcare NHS Trust, in London, England, who have been pioneering the use of flexible robotics in vascular interventions.

Along with the presentations at the VEITHsymposium, an additional presentation featuring Hansen Medical's investigational vascular robotic system will be offered at the AIMsymposium™, which is focused on interventionalists, sponsored by the Cleveland Clinic and being held concurrently at the Hilton New York.

The presentations will include:

  • A breakfast session co-chaired by Professor Alan Lumsden, and Professor Nick Cheshire, from 6:30 a.m.-8:30 a.m. on Saturday, November 20. The session is intended for endovascular specialists interested in participating in potential post-market studies using Hansen Medical's investigational vascular robotic system, and will feature a series of presentations covering the vascular clinical and preclinical work performed on the Company's robotic Sensei® X system and investigational vascular platform. Presenters include Dr. Jean Bismuth, Dr. Celia Riga, Professor Borut Gersak, and Dr. Milenko Stankovic.

  • Professor Nick Cheshire will present "Robotics and Endovascular Navigation: Progress in and Importance for In Situ Fenestration and other Complex Procedures," from 11:32 a.m.-11:37 a.m. on Saturday, November 20.

  • At the AIMsymposium, Professor Alan Lumsden will present a review of the investigational vascular robotic system and highlights of the First in Man Study at noon, Thursday, November 18.

The Hansen Medical vascular robotic system requires regulatory clearance and is not commercially available.

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 technology.

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. Additional information can be found at www.hansenmedical.com.

Forward-Looking Statements
This press release contains forward-looking statements that involve risks, uncertainties, assumptions and other factors which, if they do not materialize or prove correct, could cause Hansen's results to differ materially from those expressed or implied by such 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 expected timing of regulatory submission, approval, clearance, and commercialization of our vascular robotic system, expectations regarding effects on clinical procedures, and expectations regarding clinical and operating actions. Important factors that could cause actual results to differ materially from those indicated by forward-looking statements include, among others, potential safety and regulatory issues that could delay, suspend or terminate clinical studies, regulatory approvals or sales, challenges in designing, engineering and manufacturing systems to function as intended, uncertain timelines, costs and results of clinical trials and development of new products, our ability to plan and manage cost-reduction or operational efficiency initiatives, the scope and validity of intellectual property rights applicable to products being developed, and our ability to remediate material weaknesses in internal controls over financial reporting. 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 November 9, 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.

Contact Information

  • Investor Contacts:
    Peter Osborne
    Interim CFO
    Hansen Medical
    650.404.5800

    Matt Clawson
    Allen & Caron Inc
    949.474.4300
    Email Contact