Regulatory Filings • Oct 13, 2014
Regulatory Filings
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Medistim launches its new product MiraQ Cardiac at EACTS
(Oslo, 13 October 2014) Medistim ASA (OSE: MEDI), a
Norwegian company that develops and commercializes
medical equipment for use in cardiac, vascular and
transplant surgery, announces that they launch its
new product MiraQ Cardiac in the European market.
The launch takes place at the annual European
Association for Cardiac-Thoracic Surgery, EACTS,
which takes place in Milan, Italy from the 12th to
the 14th of October.
MiraQ is Medistim's fourth generation of systems for
intraoperative guidance and quality assessment of
cardiac, vascular and transplant surgery. The system
platform combines "state-of-the-art" blood flow
measurement (TTFM; transit time flow measurement) and
ultrasound imaging. Compared with previous
generations, the new platform is totally upgraded
with new operating system, user interface and
electronic and mechanical components designed for the
future. The platform is flexible, modular and allows
for customer adaptations, providing exciting
commercial opportunities. The platform provides a
good foundation for Medistim's development of new
products in the future.
There is growing interest and consensus among opinion
leaders that bypass grafts and anastomoses should be
verified with a combination of intraoperative
ultrasound imaging and blood flow measurement during
surgery, and that this should become the new standard
of care. For this to become a reality, it is crucial
that technology and methods are not regarded as
obstacles in the daily routine. Medistim's philosophy
is to put the user in focus, simplify and adapt the
product to fit different user groups.
The first product to be launched based on the new
platform is MiraQ Cardiac. With MiraQ Cardiac, we
have simplified the system, while adding new features
that enhance the value and user experience for this
client group. Among other things, there is developed
a new functionality, Guided Workflows, which assists
the user with a standardized approach to quality
assurance. This makes intraoperative quality both
easier to learn and adopt into daily clinical
practice. MiraQ Cardiac has been tested by selected
customers since June this year and the feedback is
positive.
Medistim has previously announced that they want to
focus more specifically towards vascular surgery, and
the new MiraQ platform provides a good basis for
developing a product targeted for vascular
applications.
"MiraQ is a unique platform that will make it even
easier to plan, guide, assess quality and perform
surgery" says Kari E. Krogstad, CEO of Medistim ASA,
and continues: "We are proud to present a new
generation of Medistim products based on modern
technology and software. We are convinced that the
MiraQ platform will provide an important foundation
for the company's future and growth. The launch of
MiraQ is an important milestone and an important
step toward realizing our vision to make graft
patency quality assurance standard clinical practice
during by-pass surgery. "
The MiraQ platform currently has CE approval and the
product can be sold in Europe and all other countries
that accept this approval. Medistim will seek
clearance from the US Food and Drug Administration
(FDA) for the sale of MiraQ in the United States. In
parallel Medistim will seek approval from the
Ministry of Health, Labor and Welfare (MHLW) for
clearance in the Japanese market. It is expected that
these approvals will be in place by the end of 2015.
For more information, contact:
President & CEO, Kari E. Krogstad, Medistim ASA
Tel: + 47 918 38 110
Email: [email protected]
CFO, Thomas Jakobsen, Medistim ASA
Tel: + 47 906 59 940
Email: [email protected]
About Medistim
Medistim was established in 1984, and has a track
record of profitable growth over the past >10 years.
The company is a pioneer within its segment, and
continues to invest in new product development.
Medistim has wholly owned subsidiaries with sales
organizations in the US, Germany, Denmark, UK and
Norway, in addition to the around 50 distributors in
Europe, Asia, Middle East, Africa and South
America. For more information, visit the Medistim
home page: www.Medistim.com
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