Regulatory Filings • Jan 22, 2016
Regulatory Filings
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Medistim launches its new product MiraQ in the US
(Oslo, 22 January 2016) Medistim ASA (OSE: MEDI), a
company that develops and commercializes medical
equipment for guidance and quality assurance within
cardiac, vascular and transplant surgery, announces
that they launch its new product MiraQ in the US
market.
The launch takes place at the annual US Conference
arranged by The Society of Thoracic Surgeons, STS,
which takes place in Phoenix, Arizona, USA from the
23rd to the 27th of January.
MiraQ is Medistim's fourth generation of systems for
intraoperative quality 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 modality. 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 the foundation
for the MiraQ Cardiac product for use within coronary
bypass surgery, MiraQ Vascular within Vascular surgery
and MiraQ Ultimate that combines both solutions.
There is growing interest and consensus among opinion
leaders that bypass graft and anastomoses should be
verified with a combination of intra-operative
ultrasound imaging and blood flow measurement during
surgery, and that this should be standard clinical
practice in the future. For this to become a reality,
it is crucial that technology and methods do not
hinder the application. Medistim's philosophy is to
put the user in focus, simplify and adapt the product
to fit different user groups.
With the MiraQ products, we have simplified the
system, while adding new features that enhance the
value and user experience for the clients. 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.
As part of the STS congress, the organizers are
arranging a training program called LearningLab.
During the congress Medistim will, as part of the
LearningLab program, arrange a training session using
Medistim MiraQ equipment. The program is based on real
cases. The cases show how the surgeon are guided
through the operation and how they can achieve quality
assurance of their work based on the information
provided by MiraQ.
"MiraQ is a unique platform that will make it even
easier to plan, assure quality and perform surgery"
says Kari E. Krogstad, CEO of Medistim ASA, and
continues: "In line with our plans we are now proud to
present the newest generation of Medistim products in
the US, and through LearningLab we are able to really
demonstrate the clinical value of our solutions. We
are convinced that the MiraQ platform will provide a
sound foundation for the company's future and growth
in the US. 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 also
in the US market. "
The MiraQ platform has currently clearance for sale
from FDA(Food and Drug Administration) and a CE
approval, and the products can be sold in the US and
Europe. Medistim are seeking approval from the
Ministry of Health, Labor and Welfare (MHLW) for
clearance in the Japanese market and the health
authorities in China, China Food and Drug
Administration (CFDA) for clearance for sale in China.
It is expected that these approvals will be in place
by 2016.
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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