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Company to Commence Initial Commercial Launch in the United States Immediately; Hansen Medical to Host Conference Call Today at 2:00 PM PT

Mon, 06/04/2012 - 10:45am
The Associated Press

(http://www.hansenmedical.com)

Hansen Medical, Inc. (NASDAQ: HNSN), a global leader in intravascular

robotics and the developer of robotic technology for accurate 3D

control of catheter movement, today announced that it has received

510(k) clearance from the U.S. Food and Drug Administration (FDA) for

its Magellan? Robotic System, including the catheter and accessories.

The Company will commence commercialization at selected centers in the

U.S. immediately, with a full launch expected later in the year. The

product will be presented at the 66th Vascular Annual Meeting of the

Society for Vascular Surgery at National Harbor, Maryland from June

7-9.

The Magellan Robotic System is intended to facilitate navigation to

anatomical targets in the peripheral vasculature and subsequently

provide a conduit for manual placement of therapeutic devices. The

System has the potential to provide vascular surgeons and other

interventionalists the ability to perform fast and predictable

procedures, while allowing the physician to be seated comfortably away

from the radiation source, which may reduce radiation exposure and

physician fatigue.

"Today's announcement marks one of the most significant milestones in

the Company's history," said Hansen Medical President and CEO Bruce

Barclay. "Not only does the Magellan System have the potential to be a

significant growth driver for Hansen, it also represents a fundamental

step forward in the transformation of vascular intervention using

intravascular robotics."

The global vascular market is large and expanding rapidly, driven by

an aging population, the prevalence of diabetes and obesity, and an

increase in disease awareness. Of the more than 3 million vascular

procedures done worldwide each year, approximately one-third to

one-half of them could be addressed using the Magellan Robotic System.

Dr. Alan Lumsden, Chair of Hansen Medical's U.S. Scientific Advisory

Board, and Chair of the Department of Cardiovascular Surgery and

Medical Director of Methodist DeBakey Heart and Vascular Center at The

Methodist Hospital, Houston, commented, "The Magellan Robotic System

is a significant technological advancement that may offer important

clinical benefits for physicians performing peripheral interventions.

The System provides physicians with independent robotic control of

both catheter tips to navigate efficiently through a variety of

anatomies and lesions. Our in vitro and in vivo animal studies

indicate that using this platform has the potential to increase

efficiencies in the interventional lab by shortening procedure times

and allowing more predictable interventions. Ultimately, we believe

this System may facilitate alternative patient treatment options by

enabling robotic endovascular interventions."

The Magellan Robotic System results in a new standard for peripheral

vascular intervention that has the potential to deliver revolutionary

lesion access, precise distal tip control, solid catheter stability

and consistent procedural efficiency.

Dr. Jean Bismuth, a leading vascular surgeon at the DeBakey Heart and

Vascular Center at The Methodist Hospital, Houston, said, "Since the

Magellan Robotic System was designed specifically for vascular

interventions, it offers excellent catheter stability and precision

during the delivery and placement of a variety of therapeutic devices

in different anatomic conditions, including various peripheral

vascular diseases with tortuous anatomy. Additionally, the Magellan

Robotic System may offer physicians less radiation exposure and

reduced procedural fatigue due to the remote workstation that allows

the physician to be seated comfortably outside the imaging suite."

The Company believes the Magellan platform also provides a compelling

value proposition to hospitals.

"Hospitals today need to ensure not only quality patient care, but

also sound fiduciary judgment in all purchase decisions," continued

Barclay. "To remain competitive in the markets they serve, hospitals

need to become more efficient, while also increasing their patient

capacity. The Magellan Robotic System has the potential to help

hospitals accomplish both of these goals."

"We are excited about the initial interest a number of key U.S.

hospitals have shown in the Magellan System and intend to focus our

near-term commercialization strategy on partnering with a select group

of esteemed physicians who are both influential and early adopters of

new technologies in the industry," said Barclay. "We will provide them

with the appropriate training and engage with them to demonstrate the

benefit and value of the Magellan. This focused and controlled

commercial launch should enable us to generate positive clinical

experiences and data to drive both interest and adoption among other

physicians and hospitals in the large and rapidly expanding U.S.

peripheral vascular market, and will be followed later this year with

full launch activities."

Barclay concluded, "Today's announcement is a testament to the

immensely talented development and support teams at Hansen Medical

that worked tirelessly to reach this important milestone, and I want

to personally congratulate and thank them for their hard work."

The Magellan System received a CE Mark in the European Union last

year, and the Company has already commenced a commercial launch in

that region. In addition, the System has been approved in Australia,

and is pending approval in Canada.

About the Magellan? Robotic SystemHansen Medical's Magellan 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 more than 8,000 patients, but includes

a number of key enhancements. In particular, the Magellan Robotic

System:

Hansen Medical Conference CallCompany management will hold a

conference call to discuss the receipt of 510(k) clearance for the

Magellan Robotic System today, June 4, 2012, at 2:00 p.m. Pacific

(5:00 p.m. Eastern). Investors are invited to listen to the call live

via the Internet using the link available within the "Investor

Relations" section of Hansen Medical's website at

http://www.hansenmedical.com/(http://ctt.marketwire.com/?release=894950&id=1674565&type=1&url=http%3a%2f%2fwww.hansenmedical.com%2f).

Additionally, participants can dial into the live conference call by

calling 877-941-1427 or 480-629-9664. An audio replay of the webcast

will be available approximately one hour after the completion of the

conference call through June 11, 2012, by calling 877-870-5176 or

858-384-5517, and entering access code 4544736.

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 both CE marking and 510(k) clearance and are commercially

available in the European Union, and the U.S.

Additional information can be found at

www.hansenmedical.com(http://ctt.marketwire.com/?release=894950&id=1674568&type=1&url=http%3a%2f%2fwww.hansenmedical.com%2f).

Forward-Looking StatementsThis 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 benefits of our

Magellan Robotic System on the vascular procedures and the timing and

results of commercializing our Magellan 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 March 31, 2012 filed with

the SEC on May 7, 2012 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, and Magellan is a

trademark of Hansen Medical, Inc. in the United States and other

countries.

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