Hansen Medical, Inc. (NASDAQ: HNSN), a global leader in
intravascular robotics, today announced changes to its Board of
Directors. Effective immediately, Stephen L. Newman, M.D. and Nadim
Yared have been appointed as Directors. Hansen Medical's Board now
consists of nine members, eight of whom are non-executives.
"Stephen and Nadim bring a wealth of experience in the
healthcare industry and complement our existing Board," said Bruce
Barclay, Hansen Medical's President and Chief Executive Officer.
"Together, Stephen and Nadim have a combined 50 years of experience
in the healthcare industry, most of which have been spent in senior
operational and commercial roles. In particular, Stephen's
substantial hospital management expertise and Nadim's significant
medical device sales leadership should be instrumental to Hansen as
we continue to execute on our commercial strategy for our Magellan™
Robotic System and Sensei® X Robotic Catheter System."
Having served in increasingly senior positions at Tenet
Healthcare Corporation over the past 13 years, Dr. Newman has
extensive healthcare operations experience. In his recently
completed role as Vice Chairman, Dr. Newman led Tenet's health
information technology project deployment, the company's medical
staff development efforts and its quality, safety and service
initiative. Prior to his appointment to Vice Chairman in January of
this year, Dr. Newman served as Corporate Chief Operating Officer,
Executive Vice President, for five years, where his
responsibilities included strategic and operational oversight of
Tenet's 49 hospitals and 100 ambulatory and imaging centers.
Before his tenure at Tenet, Dr. Newman served as President and
Chief Executive Officer of HCA's Louisville HealthCare Network,
where he had operating responsibilities for three hospitals and
3,000 employees within a $500 million business. Dr. Newman also
currently serves on the Federal Reserve Bank of Atlanta's Labor,
Education and Healthcare Council and recently completed a five year
term on the Board of Directors of the Federation of American
Hospitals.
"I am very excited to join the Board of Hansen Medical at such a
critical juncture for the Company," said Dr. Newman. "I look
forward to utilizing my significant experience in managing
hospitals and health systems to help Hansen deliver its compelling
value proposition for the Company's Magellan and Sensei
Systems."
Mr. Yared's career in the medical device industry has spanned
nearly 20 years. He currently serves as the President and Chief
Executive Officer of CVRx, Inc., a privately-held medical device
company developing the Rheos neo™ system, an active implantable
device for the treatment of hypertension and heart failure. During
his six years in this position, Mr. Yared has helped CVRx raise
significant funding to develop the company's next generation
technology and conduct clinical trials.
Preceding his term at CVRx, Mr. Yared served as Vice President
and General Manager of Medtronic, Inc. for four years. During his
tenure, he directed sales, marketing, business development,
product/technology development and manufacturing of surgical
medical imaging products. Until 2002, Mr. Yared held increasingly
senior positions at GE Medical Systems over a period of nine years.
Much of his focus during this time was medical device sales and
marketing management. Mr. Yared also currently serves on the boards
of the medical device industry trade group, AdvaMed, and Intio, a
privately-held interventional oncology company.
"The recent FDA clearance of Hansen's Magellan Robotic System
represents a significant achievement for the Company," said Mr.
Yared. "I look forward to lending my sales and marketing expertise
to the Board."
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™
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. In the European
Union, the Company's Sensei® 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® 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 US 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.
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
benefits of our Magellan Robotic System on 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), Sensei and Lynx are registered trademarks, and Magellan
and NorthStar are trademarks of Hansen Medical, Inc. in the United
States and other countries. Rheos neo is a trademark of CVRx,
Inc.
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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