Hansen Medical to Highlight Sensei(R) X Robotic Catheter System and New Artisan
Extend(R) Control Catheter at Heart Rhythm Society Annual
MOUNTAIN VIEW, CA -- (Marketwired) -- 04/29/13 -- Hansen Medical,
Inc. (NASDAQ: HNSN), a global leader in intravascular robotics, today
announced that it will showcase its Sensei(R) X Robotic Catheter
System with the new Artisan Extend(R) Catheter at the Heart Rhythm
Society's (HRS) 34th Annual Scientific Sessions from May 8-11, 2013
in Denver, CO. The Company will be exhibiting the Sensei X System at
Hansen Medical's Artisan Extend Catheter includes a simplified flush
design that can improve physician workflow during complex
electrophysiology procedures, and allows for lower manufacturing
costs. The Company completed a limited release of the new catheter in
January, and it is now in full release in both the U.S. and Europe.
"We are encouraged by our growing EP business, as evidenced by the
record procedures and catheter sales we delivered in 2012. We have
experienced six consecutive quarters of procedure growth, and look
forward to building on this positive momentum at HRS," said Bruce
Barclay, President and CEO of Hansen Medical. "Our record EP
procedures and the greater than 10,000 clinical cases performed to
date are a testament to the continued market adoption and clinical
relevance of our Sensei X System and the value that it delivers to
patients, physicians, hospitals, and payers. The initial clinical
results from our Artisan Extend Catheter have been positive, which is
important because the success of this catheter, as well as our
Lynx(R) Ablation Catheter in Europe, are key elements of our EP
business growth strategy."
Other highlights of the HRS Scientific Sessions include:
-- Dr. Luigi Di Biase, Senior Researcher at the Texas Cardiac Arrhythmia
Institute, will discuss his clinical experience with the Sensei X
Robotic Catheter System in Room 304 on Thursday, May 9, from 12:55 pm
- 1:15 pm.
-- Dr. Antonio Dello Russo, Cardiac Arrhythmia and Heart Failure Research
Center, Catholic University of the Sacred Heart, San Camillo-Forlanini
Hospital, Rome, Italy, will present multi-center research on robotic
contact force sensing. The abstract will be displayed in the Exhibit
Hall Thursday, May 9, from 2:00 pm - 5:00 pm.
-- Dr. Rahul Doshi from the University of California and Fullerton
Cardiovascular Medical Group, will speak about the Sensei X Robotic
Catheter System in Room 205 on Friday, May 10, 5:00 pm - 5:30 pm.
-- Dr. J. Michael Mangrum, Associate Professor of Medicine and Director
of the Atrial Fibrillation Center at the University of Virginia, will
present research on Endosense contact force sensing and the Sensei X
Robotic Catheter System. The abstract will be displayed in the Exhibit
Hall Friday, May 10, 2:00 pm - 5:00 pm.
More information about each of these Scientific Sessions may be found
About Sensei(R) X Robotic Catheter System
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 has been used in over 10,000 patients, and is powered by a
robotically controlled arm that allows for catheter navigation,
stability and positioning within the patient's heart atria, allowing
for the following system advantages:
-- Catheter Stability with Force-Sensing
-- Instinctive 3D Control
-- Reduced Fluoro Time for Physician
About Hansen Medical, Inc.
Hansen Medical, Inc., based in Mountain
View, California, is the global leader in intravascular robotics,
developing products and technology designed to enable the accurate
positioning, manipulation and control of catheters and catheter-based
technologies. The Company's Magellan(TM) Robotic System, Magellan
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. In the European Union, the Company's Sensei(R) X Robotic
Catheter System and Artisan Control Catheter are cleared for use
during electrophysiology (EP) procedures, such as guiding catheters
in the treatment of atrial fibrillation (AF), and the Lynx(R) Robotic
Ablation Catheter is cleared for the treatment of AF. This robotic
catheter system is compatible with fluoroscopy, ultrasound, 3D
surface map and patient electrocardiogram data. In the U.S. 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 EP
procedures. 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 AF, have not been established.
Additional information can be found at www.hansenmedical.com.
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," "anticipates," 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 for
hospitals, patients and physicians, expectations of shipments and
installations of our robotic systems, catheter sales, and procedures,
expectations of gross margins and operating expenses for 2013, the
sufficiency of the company's cash resources for supporting the
Company's operations, expected efficiencies from cost saving
initiatives, and the anticipated timing of commercially launching a
6F vascular catheter. Important factors that could cause actual
results to differ materially from those indicated by such
forward-looking statements include, among others: engineering,
regulatory, manufacturing, sales and customer service challenges in
developing new products and entering new markets; the commercial
viability of our products in the vascular markets; potential safety
and regulatory issues that could slow or suspend our sales; the
effect of economic conditions on capital spending by our potential
customers; the uncertain timelines for the sales cycle for newly
introduced products; the rate of adoption of our systems and the rate
of use of our catheters; the scope and validity of intellectual
property rights app
licable 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;
our ability to manage expenses and cash flow, and obtain additional
financing; and other risks more fully described in the "Risk Factors"
section of our Annual Report on Form 10-K for the year ended December
31, 2012 filed with the SEC on March 18, 2013 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), Sensei and Lynx are registered trademarks, and Magellan and
NorthStar are trademarks of Hansen Medical, Inc. in the United States
and other countries.
Peter J. Mariani
Chief Financial Officer
Hansen Medical, Inc.
FTI Consulting, Inc.
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