SOURCE: Hansen Medical, Inc.

Hansen Medical, Inc.

February 02, 2012 08:00 ET

The Methodist Hospital to Pioneer Vascular Research With Hansen Medical Vascular Robotic System

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

MOUNTAIN VIEW, CA--(Marketwire - Feb 2, 2012) - Hansen Medical, Inc. (NASDAQ: HNSN), a global leader in flexible catheter robotics and the developer of robotic technology for accurate 3D control of catheter movement, today announced that The Methodist Hospital, Houston, TX, has purchased a preclinical vascular robotic system from Hansen Medical and will be conducting advanced preclinical endovascular research.

The acquisition of the preclinical vascular robotic system reinforces The Methodist Hospital's commitment to pioneering the use of robotic catheter technologies.

"We are very pleased with the addition of a preclinical vascular robotic system dedicated to preclinical vascular research," said Dr. Alan Lumsden, Chair of the Department of Cardiovascular Surgery and Medical Director of Methodist DeBakey Heart and Vascular Center at The Methodist Hospital. "It is our intention to create an institutional focus on cardiovascular robotics. Our robotic technology capability, which now includes three Sensei systems in addition to this preclinical vascular system, is extremely well positioned to permit us to become one of the leading cardiovascular robotics programs in the world and to serve all three of our missions: research, education and clinical activity."

"We are delighted with the decision of The Methodist Hospital to acquire a Hansen Medical vascular robotic system to spearhead preclinical vascular research," said Bruce Barclay, president and CEO of Hansen Medical. "The Methodist Hospital has built a very successful robotics program in electrophysiology with our Sensei robotic systems, and their investment in a preclinical vascular system reflects their confidence in Hansen Medical's technological leadership."

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 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.

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 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

  • 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