PARIS--(BUSINESS WIRE)--Regulatory News:
Mauna Kea Technologies (Euronext: MKEA, OTCQX: MKEAY) inventor of Cellvizio®, the multidisciplinary probe-based confocal laser endomicroscopy (pCLE) platform, today announced the decision by the Korean Center for New Health Technology to grant Cellvizio® New Health Technology status. This status recognizes confocal laser endomicroscopy as a “safe and effective method that can help identify cancerous lesions and biopsy locations for patients with suspicion of dysplasia of the esophagus, stomach, and strictures in the bile ducts”. Further, it enables Cellvizio to be eligible for specific reimbursement codes for procedures in South Korea, the third largest imaging market in Asia.
“This important recognition from NECA demonstrates the distinct clinical and innovative benefits of Cellvizio for improving care of patients suffering from esophageal, gastric and biliary diseases,” said Sacha Loiseau, Ph.D., Founder and Chief Executive Officer of Mauna Kea Technologies. “Furthermore, the decision represents a major step toward securing reimbursement of Cellvizio in South Korea, which would enable access to confocal laser endomicroscopy for a large patient population. We also see this decision as a clear sign that Cellvizio is becoming a standard of care for GI applications on a global basis.”
South Korea, a country of 51 million people, is making strong investments to become a world leader in the medical device industry with a particular emphasis on medical imaging equipment and processing software. Through its long-standing distribution partner in Korea, Mauna Kea Technologies will accelerate the deployment of endomicroscopy in key centers around the country and will continue to raise awareness through numerous marketing initiatives in 2018.
NECA (the National Evidence-based healthcare Collaborating Agency) is a Health Technology Assessment (HTA) organization, member of the same network of agencies (INAHTA) as the French Haute Autorité de Santé (HAS) the British NIHR – National Institute for Health Research or the American AHRQ – Agency for Healthcare Research and Quality. NECA is supervised by the Ministry of Health and Welfare (MoHW). The New Health Technology Assessment (nHTA) Committee uses a systematic literature review to search, analyze and contemplate existing studies comprehensively and without bias as the basis for evaluating the applications.
About Mauna Kea Technologies
Mauna Kea Technologies is a global medical device company focused on eliminating uncertainties related to the diagnosis and treatment of cancer and other diseases thanks to real time in vivo microscopic visualization. The Company’s flagship product, Cellvizio, has received clearance to sell a wide range of applications in more than 40 countries, including the United States, Europe, Japan, China, South Korea, Canada, Brazil and Mexico. For more information on Mauna Kea Technologies, visit www.maunakeatech.com
This press release contains forward-looking statements concerning Mauna Kea Technologies and its activities. Such forward looking statements are based on assumptions that Mauna Kea Technologies considers to be reasonable. However, there can be no assurance that the anticipated events contained in such forward-looking statements will occur. Forward- looking statements are subject to numerous risks and uncertainties including the risks set forth in the registration document of Mauna Kea Technologies registered by the French Financial Markets Authority (Autorité des marchés financiers (AMF)) on June 13, 2016 under number R.16-054 and available on the Company's website (www.maunakeatech.com), and to the development of economic situation, financial markets, and the markets in which Mauna Kea Technologies operates. The forward-looking statements contained in this release are also subject to risks unknown to Mauna Kea Technologies or that Mauna Kea Technologies does not consider material at this time. The realization of all or part of these risks could lead to actual results, financial conditions, performances or achievements by Mauna Kea Technologies that differ significantly from the results, financial conditions, performances or achievements expressed in such forward-looking statements. This press release and the information it contains do not constitute an offer to sell or to subscribe for, or a solicitation of an order to purchase or subscribe for, Mauna Kea Technologies shares in any country.