Hansen Medical Reports Preliminary Fourth Quarter and Full-Year
2013 Results and Recent Business Highlights
Company Meets Previously Communicated 2013 Outlook for
Commercialization of Systems and Estimated Procedures;
Commercialized Six Robotic Systems in the Quarter, Bringing Total
Commercialized Systems For 2013 to 14; Physicians Performed an
Estimated 815 Procedures in the Quarter, Bringing Total Estimated
Procedures Performed in 2013 to a Record 3,210, Up 19% Over 2012;
Two Additional Hospitals Named as Magellan Centers of Excellence in
the U.S. for the Training of Physicians and Medical Staff
MOUNTAIN VIEW, CA--(Marketwired - Jan 13, 2014) - Hansen
Medical, Inc. (NASDAQ: HNSN), a global leader in intravascular
robotics, today reported selected preliminary fourth quarter and
full-year 2013 results in advance of its presentation at the 32nd
Annual J.P. Morgan Healthcare Conference on January 16, 2014 in San
Francisco, CA.
Selected Fourth Quarter 2013 Preliminary Results and Business
Highlights
- Commercialized six robotic systems in the quarter, including
the previously reported conversion of one evaluation system to a
sales transaction, and the conversion of an additional evaluation
system to a short-term rental agreement while the hospital
continues to evaluate the potential purchase of the system.
- The six robotic systems include five Magellan™ Systems and one
Sensei® X System
- Commercialized a total of 14 robotic systems in 2013, including
nine Magellan and five Sensei Systems. The Company uses the term
"commercialize" to refer to revenue-generating transactions,
including the conversion of evaluation units.
- Physicians performed an estimated 815 Hansen Medical robotic
procedures in the fourth quarter, up approximately 9% sequentially,
and 8% over the prior year. Total estimated procedures for the year
were a record 3,210, an increase of approximately 19% over the
prior year.
- Two additional hospitals named as Magellan Centers of
Excellence for the training of physicians and medical staff in the
U.S. The hospitals include the Keck Medical Center at the
University of Southern California in Los Angeles, CA, and Premier
Health Miami Valley Hospital, in Dayton, OH.
- The Company received a request from the U.S. Food and Drug
Administration (FDA) in December regarding certain clarifying
information related to Hansen Medical's filing for clearance of its
Magellan 6Fr Robotic Catheter. The Company responded to the FDA's
request and continues to expect to receive product clearance in the
first quarter of 2014.
"We continue to see increasingly positive trends in our business
and are pleased to report the commercialization of six robotic
systems in the fourth quarter, which brings to 10 the total number
of robotic systems commercialized in the second half of 2013," said
Bruce Barclay, Hansen Medical's President and Chief Executive
Officer. "Importantly, we met our previously communicated full-year
2013 commercialization outlook, with 14 systems commercialized, and
our estimated procedures outlook, with an estimated 3,210
procedures performed. Additionally, we continued to expand our
network of U.S. training and reference centers by naming the Keck
Medical Center at USC, and Premier Health Miami Valley Hospital in
Dayton, OH as Magellan Centers of Excellence. These hospitals have
each purchased two Magellan systems, one of which will be used in
their clinical practice and the second will be installed in their
respective training centers where physicians and medical staff can
observe and train with the Magellan system in advanced endovascular
procedures.
"We are also pleased with our progress toward receipt of FDA
clearance for our lower profile, Magellan 6Fr Robotic Catheter and
continue to expect to receive final clearance in the first
quarter," continued Mr. Barclay. "The new Magellan 6Fr Catheter
represents a second, smaller catheter platform, after the current
Magellan 9Fr Catheter, with proprietary single catheter, dual bend
technology and has the potential to expand the Magellan Robotic
System's clinical capabilities into a larger array of
interventional and endovascular therapies for physicians who prefer
a smaller puncture site and to perform smaller vessel
procedures."
Hansen Medical's J.P. Morgan Healthcare Conference
Presentation
Hansen Medical will include these selected fourth quarter and
full-year 2013 results and recent business highlights in its
presentation at the 32nd Annual J.P. Morgan Healthcare Conference
on Thursday, January 16, at 11:30 am ET (8:30 am PT). Investors are
invited to listen to the J.P. Morgan Healthcare Conference
presentation webcast live via the Internet using the link available
within the "Investor Relations" section of Hansen Medical's website
at www.hansenmedical.com.
About Hansen Medical, Inc.
Hansen Medical, Inc., based in Mountain View, California, is a
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™ Robotic System, 9Fr 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® X Robotic
Catheter System and Artisan® and Artisan Extend® Control Catheters
are cleared for use during electrophysiology (EP) procedures, such
as guiding catheters in the treatment of atrial fibrillation (AF),
and the Lynx® 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 and Artisan Extend Control Catheters
are cleared by the U.S. Food and Drug Administration for
manipulation and control of certain mapping catheters in EP
procedures. In the U.S., the Sensei X Robotic Catheter 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 Robotic Catheter
System and Artisan and Artisan Extend 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.
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," "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
regarding preliminary results for the fourth quarter of 2013, the
anticipated timing of the FDA clearance of our Magellan 6Fr Robotic
Catheter, and potential clinical capabilities for the product.
Important factors that could cause actual results to differ
materially from those indicated by such forward-looking statements
include, among others: factors relating to the finalization of
financial and operating results for the fourth quarter of 2013 and
the audit of those results by our independent auditors;
engineering, regulatory, manufacturing, sales and customer service
challenges in developing new products and entering new markets;
potential safety and regulatory issues that could slow or suspend
regulatory approval or our sales; the effect of credit, financial
and 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 applicable to our products;
competition from other companies; our ability to recruit and retain
key personnel; 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 Quarterly Report on Form 10-Q
for the quarter ended September 30, 2013 filed with the SEC on
November 8, 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.
Investor Contacts: Peter J. Mariani Chief Financial Officer
Hansen Medical, Inc. 650.404.5800 FTI
Consulting, Inc. Brian Ritchie 212.850.5683
Email Contact John Capodanno 212.850.5705
Email Contact
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