Hansen Medical Files Shelf Registration Statement
04 4월 2012 - 6:31AM
Marketwired
Hansen Medical, Inc. (NASDAQ: HNSN), a global leader in flexible
medical robotics and the developer of robotic technology for
accurate 3D control of catheter movement, today announced that it
filed a shelf registration statement on Form S-3 with the
Securities and Exchange Commission ("SEC"). Although the
registration statement relating to these securities has been filed
with the SEC, it has not yet become effective. Upon the
effectiveness of the registration statement, it will replace the
Company's previous shelf registration statement that would
otherwise expire early next year. While the Company has no current
plans to issue any securities under the registration statement, it
is the Company's practice to maintain an effective and up-to-date
shelf registration statement, and this new filing will provide the
Company with the opportunity for additional financing capacity to
access capital markets in order to respond to future financing
needs and business opportunities.
This press release shall not constitute an offer to sell or the
solicitation of an offer to buy these securities, nor shall there
be any sale of these securities in any state or jurisdiction in
which such an offer, solicitation or sale would be unlawful prior
to registration or qualification under the securities laws of any
such state or jurisdiction.
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, expectations,
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 anticipated growth of Hansen's flexible robotic technology in
both EP and vascular applications. 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 Annual Report on Form 10-K for the year
ended December 31, 2011 filed with the SEC on March 15, 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 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. Sharrifah Al-Salem, CFA 415.293.4414 Email Contact John
Capodanno 212.850.5705 Email Contact
Hansen Medical, Inc. (MM) (NASDAQ:HNSN)
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