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 Learning Lab. During the congress Medistim will, as part of the Learning Lab 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 perforsurgery” 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 Learning Lab 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.