PARIS & BOSTON--(BUSINESS WIRE)--Regulatory News:
Mauna Kea Technologies (Paris:MKEA) (OTCQX:MKEAY) (Euronext: MKEA, OTCQX: MKEAY, MKEAF) inventor of Cellvizio®, the multidisciplinary probe-based confocal laser endomicroscopy (pCLE) platform, today announced the presentation of results from a large, prospective, multi-center trial at the 2018 World Congress of Endoscopic Surgery jointly hosted by the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) and the Canadian Association of General Surgeons (CAGS), being held April 11 – 14 in Seattle, WA. The presentation was entitled, “Real-Time Diagnosis of Barrett’s Esophagus: A Prospective, Multicenter Trial Comparing Confocal Laser Endomicroscopy with Conventional Histology for the Identification of Intestinal Metaplasia in Novice Users.”
The prospective, multi-center study included 172 patients scheduled for a Barrett’s Esophagus screening or surveillance endoscopy. Random four quadrant biopsy (Seattle protocol) performed under high-definition white light endoscopy was compared to pCLE using Cellvizio and interpreted in real time and after the procedure. The key results were as follows:
- Intestinal Metaplasia (IM), or Barrett’s esophagus, was identified in 99 patients with Cellvizio compared to only 46 patients with the Seattle protocol (p<0.0001), an increase of more than 100%;
- Blinded expert review of discrepant IM detection yielded confirmation of IM detected with pCLE in 56 of 61 patients with negative tissue biopsies.
“Monitoring gastroesophageal reflux disease (GERD) is critical because Barrett’s esophagus is associated with increased risk of developing esophageal cancer,” said Paul A. Severson, MD, FACS, Co-Director, Minnesota Reflux and Heartburn Center. “The current standard methodology, the Seattle protocol, is poorly followed and has a very low diagnostic yield. Probe-based Confocal Laser Endomicroscopy is considerably more sensitive, as demonstrated in this study, even when performed by novice users.”
Sacha Loiseau, Ph.D., Founder and Chief Executive Officer of Mauna Kea Technologies added, “This large multi-center study confirms that endoscopists can more than double their detection rate of patients with intestinal metaplasia and dysplasia when using Cellvizio, with a short learning curve. This demonstrates once again not only the broad applicability of the technique in clinical practice but also its significance for patient care and cancer prevention.”
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.