PARIS, June 9, 2015 /PRNewswire/ --
- Key regulatory and product development milestone on the company's application roadmap
- Expansion of the company's needle-base device platform (nCLE) with new AQ-Flex 19 IR miniprobe
- Approval will facilitate ongoing clinical and product development including existing strategic collaborations
Mauna Kea Technologies (Euronext: MKEA, FR0010609263), inventor of Cellvizio®, the multidisciplinary confocal laser endomicroscopy platform, announced today CE mark for the use of Cellvizio in interventional radiology indications. This new regulatory milestone positions Cellvizio as a unique adjunct to important therapeutic procedures that are in great need for direct and real-time image-guidance.
"Interventional radiology is all about using our powerful non-invasive imaging modalities to guide and deliver treatments locally, as an alternative to surgical or systemic chemotherapy approaches. With the combination of Cellvizio with our existing image-guided platforms, we could be reaching a new level of precision and efficacy in our interventions," said Pr. Afshin Gangi, Chief of Interventional Radiology at the Nouvel Hôpital Civil in Strasbourg, France. "We have been very pleased with our initial experience over the past few months and are excited about this regulatory approval which will enable a faster development going forward."
Cellvizio brings real-time visualization of tissue at the microscopic level, representing a major advance in image-guided interventions. In this setting, the AQ-Flex 19 IR Cellvizio probe can be delivered through a standard percutaneous needle and provide microscopic images of lesions within solid organs such as the liver, kidney, or lung. Access to Cellvizio imaging during the procedure may provide a wide range of benefits to patients such as real-time assessment of needle-placement before focal therapeutic interventions and evaluation of completeness of tumor ablation.
Sacha Loiseau, CEO and founder of Mauna Kea Technologies declared, "While this approval is an important accomplishment for Cellvizio and a meaningful potential commercial opportunity, we do not expect Mauna Kea to be the primary marketer of AQ-Flex 19 IR as we believe that full integration of our proprietary technology into an existing interventional radiology platform would lead to a more rapid adoption of Cellvizio in this community."
About Mauna Kea Technologies
Mauna Kea Technologies is a global medical device company dedicated to the advent of optical biopsy. The company researches, develops, and markets innovative tools to visualize and detect cellular abnormalities during endoscopic procedures. Its flagship product, Cellvizio®, a probe-based Confocal Laser Endomicroscopy (pCLE) system, provides physicians and researchers high-resolution cellular views of tissue inside the body. Large, international, multi-center clinical trials have demonstrated Cellvizio's ability to help physicians more accurately detect early forms of disease and make treatment decisions immediately. Designed to improve patient outcomes and reduce costs within a hospital, Cellvizio can be used with almost any endoscope. Cellvizio has 510(k) clearance from the U.S. Food and Drug Administration and the European CE-Mark for use in the GI tract, biliary and pancreatic duct, lungs, and during fine needle aspiration procedures. Cellvizio has also been cleared by SFDA in China and MHLW in Japan for use in the GI, respiratory and urinary tract. For more information on Mauna Kea Technologies, visit http://www.maunakeatech.com
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SOURCE Mauna Kea Technologies