Hansen Medical and Philips Enter Agreements for the Development of Non-Robotic Applications of Fiber Optic Shape Sensing and Loc
03 2월 2011 - 8:50PM
Marketwired
Hansen Medical, Inc. (NASDAQ: HNSN), a global leader in flexible
robotics and the developer of robotic technology for accurate 3D
control of catheter movement, today announced that it has entered,
directly and through a wholly owned subsidiary, into patent and
technology license, sublicense and purchase agreements with Philips
to allow them to develop and commercialize the non-robotic
applications of Hansen Medical's Fiber Optic Shape Sensing and
Localization (FOSSL) technology.
FOSSL is a potentially disruptive visualization technology that
employs a fiber optic sensor designed to allow physicians to
identify both the shape and position of catheters and other tools
used in minimally invasive procedures. FOSSL has the potential to
enable more efficient and precise control and continuous tracking
of flexible tools used in these procedures. Unlike traditional
visualization methods, FOSSL is designed to provide visual
information in 3D with significant reduction in the use of x-ray.
FOSSL is being developed by Hansen Medical and Luna Innovations,
Inc. which are jointly advancing its use in medical
applications.
Under the terms of the agreements, Philips has the exclusive
right to develop and commercialize the FOSSL technology in the
non-robotic vascular, endoluminal and orthopedic fields. In
addition, the parties have amended their previous joint development
agreement to allow for Philips to potentially extend and increase
certain fees to be paid by Hansen Medical based on the future sales
of the currently investigational flexible catheter vascular robotic
system now under development at Hansen Medical with planned
commercialization in the US and Europe in 2011. Hansen Medical will
receive upfront payments of $29 million in connection with these
arrangements and will be eligible to receive up to an additional
$78 million in future payments associated with the successful
commercialization or licensing by Philips or its collaborators of
products containing FOSSL technology.
"Today's announcement is an important milestone in the history
of Hansen Medical," said Bruce Barclay, President and CEO of Hansen
Medical. "As a result of the hard work by our talented employees,
we have made tremendous strides evolving our business strategy and
focusing on new market opportunities to create a proprietary mode
of safe and effective imaging. We are pleased to expand our
relationship with Philips, and are now in a position to further
develop and commercialize this technology which has the potential
to improve clinical outcomes for future medical products, including
to significantly reduce the amount of harmful radiation generated
in interventional procedures, all to the benefit of patients,
physicians and hospital staffs. Finally, these agreements allow us
to significantly enhance our cash position and strengthen our
balance sheet without incurring a dilutive event for our
shareholders."
"These agreements represent a considerable step forward in the
relationship between Hansen Medical and Philips Healthcare in
bringing innovative technology solutions to patients and physicians
in multiple medical fields from orthopedics to interventional
procedures. We are delighted to be moving forward with Philips on
both the application of the FOSSL technology outside of robotics
and on the advancement of our robotics technology for vascular
procedures," said Robert Mittendorff, M.D. Vice President of
Marketing and Business Development at Hansen Medical.
While minimally invasive procedures have advanced significantly
in the past 30 years, their potential is still limited by imaging
and localization, which remain critical elements to knowing where
flexible tools are in the body. Since the incision is so much
smaller than typical open surgery and direct visualization is not
possible, physicians have to rely on X-ray imaging or localization
to know where their instruments are and the shape of the
instruments they are manipulating. Significant radiation exposure
to the patient and physician is often the result, and usually
provides only two dimensional information. With FOSSL enabled
devices, the potential benefits to patients and the physicians that
treat them are substantial, including increased efficiency, control
and reduced use of radiation in minimally invasive procedures.
Hansen Medical Conference Call
Company management will hold a conference call to discuss its
new agreements with Philips today, February 3, 2011, at 5:30 a.m.
Pacific (8:30 a.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
www.hansenmedical.com. A replay of the webcast will be available
approximately one hour after the completion of the live call.
Additionally, participants can dial into the live conference call
by calling 877-941-2322 or 480-629-9715. An audio replay will be
available approximately one hour after the completion of the
conference call through February 10, 2011, by calling 877-870-5176
or 858-384-5517, and entering access code 4408407.
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® system and its Sensei X Robotic
Catheter System 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 and Sensei X systems for use with
cardiac ablation catheters in the treatment of cardiac arrhythmias,
including atrial fibrillation (AF), have not been established
during EP procedures, such as guiding catheters in the treatment of
AF. In the European Union, the Sensei and the Sensei X systems are
cleared for use during EP procedures, such as guiding catheters in
the treatment of AF. The flexible catheter vascular robotic system
requires regulatory filings and approval and is not commercially
available. Additional information can be found at
www.hansenmedical.com.
Forward-Looking Statements This press
release contains forward-looking statements that involve risks,
uncertainties, assumptions and other factors which, if they do not
materialize or prove correct, could cause Hansen Medical's results
to differ materially from those expressed or implied by such
forward-looking statements. All statements, other than statements
of historical fact, are statements that could be deemed
forward-looking statements, including statements containing the
words "plan," "expects," " believes," "potential," and similar
words. Hansen Medical intends such forward-looking statements to be
covered by the safe harbor provisions for forward-looking
statements contained in Section 21E of the Exchange Act and the
Private Securities Litigation Reform Act of 1995. Examples of such
statements include statements regarding expectations for the
commercialization of the FOSSL technology and our flexible catheter
vascular robotic system. Important factors that could cause actual
results to differ materially from those indicated by
forward-looking statements include, among others, the realization
of the full potential benefits of the agreements with Philips
requires the development of new products and applications of
technology that are subject to design, engineering and
manufacturing challenges, potential safety and regulatory issues
that could delay, suspend or terminate clinical studies, regulatory
approvals or sales, and reliance on third parties to develop,
obtain regulatory approval for, manufacture, market and sale of
products containing FOSSL technology. These and other risks are
described in greater detail under the heading "Risk Factors"
contained in our periodic SEC filings, including our Quarterly
Report on Form 10-Q filed with the SEC on November 9, 2010. Given
these uncertainties, you should not place undue reliance on the
forward-looking statements in this press release. Hansen Medical
undertakes 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, Hansen Medical & Heart Design,
and Sensei are registered trademarks of Hansen Medical, Inc. in the
United States and other countries.
Hansen Medical Contacts: Peter Osborne Interim CFO Hansen
Medical 650.404.5800 Matt Clawson Allen & Caron Inc
949.474.4300 Email Contact
Hansen Medical, Inc. (MM) (NASDAQ:HNSN)
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