MiraQ™ Cardiac Launched in the European Market

(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 standardof 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.