PARIS--(BUSINESS WIRE)--Regulatory News:
Mauna Kea Technologies (Paris:MKEA) (Euronext: MKEA, OTCQX: MKEAY) inventor of Cellvizio®, the multidisciplinary confocal laser endomicroscopy (CLE) platform, today announced a new peer-reviewed publication from the Singapore Gastric Cancer Consortium1 highlighting the excellent results utilizing Cellvizio in improving diagnostic yield in gastric cancer, including the need for two-thirds fewer biopsies to confirm the presence of disease. The publication includes a meta-analysis of studies utilizing CLE with Cellvizio in gastric diseases, demonstrating superior results compared to conventional imaging modalities also evaluated in the study, including chromoendoscopy and narrow band imaging.
Sacha Loiseau, Ph.D., Founder and Chief Executive Officer of Mauna Kea Technologies, said, “This publication highlights a compelling opportunity to utilize Cellvizio to reduce uncertainties in the diagnosis, treatment and monitoring of patients with gastric cancer and disease. It clearly demonstrates the improved diagnostic performances, both in terms of identifying disease and guiding biopsies, when utilizing CLE in gastric cancer as compared to standard imaging technologies. Gastric cancer is the third leading cause of cancer death worldwide and is the most prevalent cancer in the Asia-Pacific region. We look forward to raising awareness of these powerful results and to expanding Cellvizio adoption to benefit more patients around the world.”
Key data from the meta-analysis performed on CLE and gastric diseases include:
- 85% sensitivity and 99% specificity in detecting and diagnosing polyps and neoplastic lesions
- 94% sensitivity and 95% specificity in detecting and diagnosing gastritis and gastric metaplasia
- 86% sensitivity and 93% specificity in detecting and diagnosing H. pylori-related gastritis
In this same paper, the authors reminded their local experience resulting in following results:
- Two-third fewer biopsies required to confirm gastric intestinal metaplasia compared to conventional imaging
- Higher diagnostic yield of 65.7% for gastric intestinal metaplasia, compared to 15.7% with conventional imaging (p<0.001)
Almost one million new cases of stomach cancer were estimated to have occurred in 2012, making it the fifth most common malignancy in the world, after cancers of the lung, breast, colorectum and prostate. Half the world total occurs in Eastern Asia (mainly in China). Stomach cancer is the third leading cause of cancer death in both sexes worldwide (723,000 deaths, 8.8% of the total). The highest estimated mortality rates are in Eastern Asia (24 per 100,000 in men, 9.8 per 100,000 in women)2.
In their summary table, the authors considered CLE as a mature technology and not necessitating additional clinical evidence in this application, and highlighted the importance of adequate training for accurate CLE diagnosis.
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, Canada, Brazil and Mexico. For more information on Mauna Kea Technologies, visit www.maunakeatech.com
1 Publication by JWJ Lee, LG Lim and KG Yeoh. Advanced
endoscopic imaging in gastric neoplasia and preneoplasia, BMJ Open
2 World Health Organization, Globocan 2012: http://globocan.iarc.fr/old/FactSheets/cancers/stomach-new.asp
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.