SOURCE: Hansen Medical, Inc.

Hansen Medical, Inc.

November 17, 2010 16:01 ET

Hansen Medical Names Jean Chang Vice President of Engineering

Brings Substantial Experience in Product Development of Multiple Catheter-Based Technologies for Use in the Vascular Anatomy

MOUNTAIN VIEW, CA--(Marketwire - November 17, 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 engineering executive Jean Chang has been named Vice President, Engineering, effective immediately. Chang will report directly to President and CEO Bruce Barclay.

Chang, 50, spent the past seven years as Vice President, Engineering and Operations at CardioMind Inc., a developer of guidewire based stent systems for interventional cardiology and neuroradiology that was sold to Biosensors earlier this year. Along with responsibilities for R&D and operations, Chang was also involved in regulatory and clinical affair activities for CardioMind.

"Jean has a broad background in research and development of catheter-based products, including a strong clinical understanding of how these devices are used in the hands of physicians, which translates well for our needs here at Hansen Medical," Barclay said. "Her technical expertise lends itself to product development from inception through pre-clinical testing and regulatory approval, which will help us as we work closely with European and U.S. regulators on our flexible robotic systems, both for electrophysiology and vascular applications. Perhaps most importantly, multiple technology programs that she has managed have resulted in commercially successful products and are now used widely in both coronary and peripheral clinical applications. We look forward to Jean joining our team."

"Hansen Medical's flexible robotic platforms offer tremendous potential in the vascular space by improving procedural times and ultimately clinical outcomes in difficult diseased anatomies. I am excited to join Hansen and work with the talented technical teams towards commercialization and clinical adoption of Hansen's innovative robotic catheter systems," said Chang.

Prior to her work at CardioMind, Chang spent six years in various capacities at EMBOL-X, a company that developed various embolic protection devices for cardiac surgery before it was sold to Edwards Lifesciences in 2003. She was Chief Operating Officer from November 2000 until the sale of the company. Chang has also worked in various management positions at Cordis and Advanced Cardiovascular Systems/Guidant. She has bachelor's degrees in Materials Science and Engineering, and Life Sciences from MIT. She also holds a Master of Science degree in Bioengineering from UC San Francisco.

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