Date Announced: 15 Mar 2018
New Health Technology Assessment (nHTA) Committee recognizes confocal laser endomicroscopy as “safe and effective technology in application for esophagus, stomach, bile duct”.
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.
Source: Mauna Kea Technologies
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Web Site: www.maunakeatech.com