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Medistim

Regulatory Filings Jan 22, 2016

3662_iss_2016-01-22_79bb2ed7-4e48-430e-ad0c-aa0c1e9d277a.html

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Medistim launches its new product MiraQ in the US

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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