SOURCE: Hansen Medical, Inc.

Hansen Medical, Inc.

Hansen Medical, Inc.

February 08, 2012 08:00 ET

Hartford Hospital to Pioneer Vascular Research With Hansen Medical Vascular Robotic System

Hospital Acquires Hansen Medical Vascular Robotic System to Conduct Preclinical Endovascular Research

MOUNTAIN VIEW, CA and HARTFORD, CT--(Marketwire - Feb 8, 2012) - Hansen Medical, Inc. (NASDAQ: HNSN), a global leader in flexible robotics and the developer of robotic technology for accurate 3D control of catheter movement, and the Center for Education, Simulation and Innovation (CESI) at Hartford Hospital in Hartford, Connecticut, today announced that Hartford Hospital has purchased a preclinical vascular robotic system from Hansen Medical for the purpose of conducting advanced preclinical endovascular research.

"We are very pleased with the addition of a Hansen Medical vascular robotic system dedicated to preclinical vascular investigation. This solidifies our position as pioneers in medical training," said Dr. Steven Shichman, Medical Director of Center for Simulation, Education and Innovation (CESI) and Chair of Peri-operative Services at Hartford Hospital. "It is our intention to create an institutional focus on endovascular and cardiovascular robotics. Our robotic technology capability, which now includes two Sensei robots, has positioned us to become one of the leading endovascular and cardiovascular robotics programs in the world."

"In January, Hansen Medical selected Hartford Hospital to be a Center of Excellence for the SENSEI® X Robotic Catheter System based on the institution's strong reputation for providing complex and innovative care and its renowned excellence in patient care, teaching and research," said Bruce Barclay, Hansen Medical's President and CEO. "This additional investment in a Hansen Medical vascular robotic system for the purpose of conducting preclinical vascular research reflects their further confidence in the potential benefits of Hansen Medical's advanced flexible robotic technology."

About the Hansen Medical Vascular Robotic System
The Hansen Medical vascular robotic system is based upon the flexible robotic technology incorporated in the Sensei X Robotic Catheter System currently sold in the U.S. and Europe, which has been used in over 7,000 patients with cardiac arrhythmia, but includes a number of key enhancements. In particular, the vascular robotic system:

  • Allows for independent, 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.
  • Preserves the open architecture featured in the Sensei System to allow for the subsequent use with most 6F therapeutic devices 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 utilizing an earlier version of the vascular robotic system, demonstrating its potential to allow physicians to effectively treat peripheral vascular disease, while lessening radiation exposure.

In Europe, the company has received CE mark approval for a vascular robotic system know as the Magellan™ Robotic System, the NorthStar™ Robotic Catheter and related accessories. In the U.S., the Magellan Robotic System requires U.S. Food & Drug Administration (FDA) clearance, and a 510(k) application is currently pending. As such, the products are not commercially available in the U.S.

About Sensei® X Robotic Catheter System
Through continued advancement of medical robotics, Hansen Medical has developed a next generation minimally-invasive, robotic catheter system, the Sensei X Robotic Catheter System which combines advanced levels of 3D catheter control and 3D visualization. This unique, state of the art technology is powered by a highly accurate, robotically controlled arm that allows for catheter navigation, stability and positioning within the patient's heart, allowing for the following system advantages:

  • Catheter Stability with Force-Sensing
  • Instinctive and Precise Catheter Placement Control
  • Reduced Radiation for Physician and Patient

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® X Robotic Catheter System and Artisan Control Catheter 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 X System and Artisan Control Catheter 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 X System and Artisan Control Catheter are cleared for use during EP procedures, such as guiding catheters in the treatment of AF, and the Lynx® Robotic Ablation Catheter is cleared for the treatment of AF. The Company's Magellan™ Robotic System, NorthStar™ Robotic Catheter and related accessories, which are intended to facilitate navigation to anatomical targets in the peripheral vasculature and subsequently provide a conduit for manual placement of therapeutic devices, have undergone conformity assessment and CE marking and are commercially available in the European Union. In the U.S., the Magellan™ Robotic System, the NorthStar™ Robotic Catheter and accessories are the subject of a current filing with the FDA and are not commercially available. Additional information can be found at www.hansenmedical.com.

About Hartford Hospital
Hartford Hospital, founded in 1854, is one of the largest teaching hospitals and tertiary care centers in New England with one of the region's busiest surgery practices. It is annually ranked among America's Best Hospitals by US News & World Report and has been recognized nationally for the quality of many of its programs, including cardiology, cancer, stroke and joint and spine care. The 867-bed regional referral center provides high-quality care in all clinical disciplines. Among its divisions is The Institute of Living, a 114-bed mental health facility with a national and international reputation of excellence. Jefferson House, a 104-bed long-term care facility, is also a special division of Hartford Hospital. The hospital's major centers of clinical excellence include cardiology, oncology, emergency services and trauma, mental health, women's health, orthopedics, bloodless surgery and advanced organ transplantation. Hartford Hospital owns and operates the state's only air ambulance system, LIFE STAR.

Forward-Looking Statements
This press release contains forward-looking statements regarding, among other things, statements relating to goals, plans, objectives, milestones and future events. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including statements containing the words "plan," "expects," "potential," "believes," goal," "estimate," and similar words. These statements are based on the current estimates and assumptions of our management as of the date of this press release and are subject to risks, uncertainties, changes in circumstances and other factors that may cause actual results to differ materially from the information expressed or implied by forward-looking statements made in this press release. Examples of such statements include statements about anticipated growth in adoption of the Sensei platform for electrophysiology procedures, the potential timing of FDA clearance of our vascular robotic system in the US, the timing of first cases to be performed with the Magellan System, 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: engineering, regulatory and sales challenges in developing new products and entering new markets; potential safety and regulatory issues that could slow or suspend our sales; the uncertain timelines, costs and results of pre-clinical and clinical trials; the rate of adoption of our systems and the rate of use of our catheters; the scope and validity of intellectual property rights applicable to our products; competition from other companies; our ability to recruit and retain key personnel; our ability to maintain our remedial actions over previously reported material weaknesses in internal controls over financial reporting; the effect of credit, financial and economic conditions on capital spending by our potential customers; our ability to manage expenses and obtain additional financing; and other risks more fully described in the "Risk Factors" section of our Quarterly Report on Form 10-Q for the quarter ended September 30, 2011 filed with the SEC on November 7, 2011 and the risks discussed in our other reports filed with the SEC. 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 of Hansen Medical, Inc. in the United States and other countries.

Contact Information

  • Hansen Contacts:
    Investor Contacts
    Peter J. Mariani
    Chief Financial Officer
    Hansen Medical, Inc.
    650.404.5800

    FTI Consulting, Inc.
    Sharrifah Al-Salem, CFA
    415.293.4414
    Email Contact

    John Capodanno
    212.850.5705
    Email Contact

    Hartford Hospital Contacts:
    Rebecca Stewart
    Director of Media Relations
    860.545.4285