mivenion receives market authorization for Xiralite® in Canada

Fluorescence optical imaging (FOI) with the Xiralite® fluorescence imaging system X4 is a sensitive and safe medical procedure for visualization of altered microcirculation in the hands in early and late stages of different diseases such as rheumatoid arthritis, psoriatic arthritis, scleroderma, osteoarthritis or Raynaud’s syndrom. Xiralite® is CE marked and already established in five European countries. The whole procedure is highly standardized, very sensitive, fast, and convenient for the patients. FOI with Xiralite® is a point-of-care diagnostic procedure and primarily used for early diagnosis of arthritis and assessment of disease activity.
mivenion is strongly focused to receive regulatory approval for Xiralite® in other relevant markets in order to build up a worldwide commercial infrastructure. The first regulatory approval outside Europe was now granted by Health Canada.
“I am delighted that we are now able to offer our innovative Xiralite® technology also to patients outside of Europe, starting with Canada”, states Malte Bahner, managing director and responsible for clinical and regulatory affairs of the fluorescence camera system Xiralite®. “Xiralite already impacts the treatment course in inflammatory joint disorders to the benefit of the patients when integrated into the decision making process. It’s great that more people will now be able to benefit from it.”
“MEDEC, the Canadian Association for medical technology industry, sees very good chances for highly sophisticated medical devices from Germany”, explains Dr. Wolfgang Barthel, Ambassador of the Leduc-Nisku Economic Partnership. “Diagnostic tests are an expanding market segment, especially early detection by imaging devices”.
Xiralite® in combination with the diagnostic dye ICG is the first dedicated solution for the Rheumascan procedure to diagnose inflammatory joint disorders in the hands. Xiralite® induces the fluorescence of ICG using light-emitting diodes (LED) and quantitatively records the fluorescence emitted in all joints of both hands. Thus active inflammation can be simultaneously diagnosed in more than 30 joints of both hands. The software XiraView® manages the data acquisition process and assists in the image analysis by trained physicians. One of the hallmarks of Xiralite is high productivity. Compared with power-doppler ultrasound or MRI examinations, users can significantly reduce time and costs of the examination procedure.

mivenion GmbH is a life-science company focusing on personalized medicine for patients with inflammatory and autoimmune diseases. With its strong expertise in both pharmaceuticals and medical devices, mivenion is providing cutting edge solutions for life-long patient care. A compelling network of academia and industry partners is supporting mivenion in achieving its goals. Broad patent applications are the foundation of mivenion’s proprietary position. mivenion’s drug development candidates comprise both diagnostic and therapeutic properties and are perfectly suited for optimizing each individual treatment case. mivenion’s medical solutions encompass innovative diagnostic imaging and provide evidence on treatment outcome. Xiralite, the leading product of mivenion, enables the Rheumascan procedure. It for the first time provides an integrated solution for patients with inflammatory diseases in the hands. Based on optical technologies, active inflammation is diagnosed at a very early stage with confidence, attractive technical ease, and high patient comfort.

Contact:
Dr. Michael Schirner
mivenion GmbH
Robert-Koch-Platz 4
10115 Berlin
Germany
Phone +49 30 68837920
info@mivenion.com

This release was published on openPR.