PARIS & BOSTON--(BUSINESS WIRE)--Regulatory News:
Mauna Kea Technologies (Paris:MKEA) (OTCQX:MKEAY) (Euronext: MKEA) inventor of Cellvizio®, the multidisciplinary probe-based and needle-based confocal laser endomicroscopy (pCLE/nCLE) platform, announced the reimbursement coverage of confocal laser endomicroscopy, specifically for Barrett’s esophagus, through the creation of a new specific procedural code to be added to the Common Classification of Medical Procedures (CCAM) published in the Official Journal of the French Republic.
In a decision dated April 18th 2019 and published in the Official Journal on June 14th 2019, the French National Association of Health Insurance Funds (UNCAM) created the following procedure, in sub-paragraph “07.01.09.01 - Endoscopy of the salivary glands and digestive tract” of Book II of the Social Security Code: “Esophageal endoscopy with confocal laser endomicroscopy-guided biopsy - Pre-therapeutic esophageal mapping with biopsy guided by confocal laser endomicroscopy” 1. The tariffs reimbursed are as follows: 150 euros for the endoscopist (Activity 1) and 69 euros for anesthesia (Activity 4). This UNCAM’s decision will take effect 30 days after its publication.
"We are pleased with the decision of the “Union Nationale des Caisses d’Assurance Maladie”, or UNCAM, to create a new code dedicated to esophageal procedures with Confocal Laser Endomicroscopy,” said Robert L. Gershon, Chief Executive Officer of Mauna Kea Technologies. “This decision confirms the relevance of our technology for patients at risk of esophageal cancer and we look forward to expanding our unique probe-based Confocal Laser Endomicroscopy system, Cellvizio, to the more than 300 hospitals throughout France that specialize in following patients with Barrett’s esophagus.”
Mr. Gershon continued: “There are more than 45,000 esophagogastroduodenoscopy procedures in France each year that potentially can be performed with Cellvizio going forward. Importantly, now clinicians performing these procedures will all be eligible for reimbursement at an attractive rate. Thanks to the creation of this new procedural code, the French market - a market in which we already enjoy a strong reputation - is finally available to Mauna Kea for broad-commercialization of our Cellvizio technology.”
About 4,300 new cases of esophageal cancer2 are diagnosed in France each year, 75% of which occur in men, more frequently beyond the age of 50. Although the epidemiology of Barrett’s esophagus is not precisely known, several studies report a prevalence of around 5.6% in the general population3,4. Barrett's esophagus is a well-recognized precursor of esophageal adenocarcinoma (subtype of esophageal cancer). Cellvizio is used to help target biopsies and may also reduce the number of biopsies needed to achieve a diagnosis.
A dossier on probe-based Confocal Laser Endomicroscopy (pCLE) was submitted to the French National Authority for Health (HAS) in 2010 by the French Society of Digestive Endoscopy (SFED). Then, the HAS conducted an assessment of real-time optical endomicroscopy performed during mapping of Barrett's esophagus and issued an opinion in favor of including this new procedure into the List of reimbursed procedures and services on September 17th 20145.
SFED has strongly supported CLE-guided biopsy esophageal mapping procedure throughout the reimbursement process and contributed to the expert panel discussions.
The UNCAM agreed to enlist probe-based confocal laser endomicroscopy on the CCAM list (i.e. French coding system of medical procedures, which concerns any medical procedure performed in an ambulatory setting or within hospital). And in 2019, a reimbursement tariff was fixed for the exam1.
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/approval in a wide range of applications in more than 40 countries, including the United States, Europe, Japan, China, 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 April 27, 2018 under number R.18-0429 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.
1 Decision of April 18th 2019 of the National
Association of Health Insurance Funds (UNCAM) on the list of procedures
and services covered by health insurance, published in the Official
Journal of the French Republic. Accessed at https://www.legifrance.gouv.fr
on June 14, 2019
2 French National Authority for Health (HAS) and National Cancer Institute (INCa). LDD n°30 - Patient guide: the management of esophageal cancer. January 2012. Accessed at https://www.has-sante.fr or https://www.e-cancer.fr
3 Rex DK, Cummings OW, Shaw M, et al. Screening for Barrett’s esophagus in colonoscopy patients with and without heartburn. Gastroenterology. 2003;125(6):1670-1677.
4 Ward EM, Wolfsen HC, Achem SR, et al. Barrett’s esophagus is common in older men and women undergoing screening colonoscopy regardless of reflux symptoms. Am. J. Gastroenterol.2006;101(1):12-17.
5 Decision n°2014.0182/DC/SEAP, https://www.has-sante.fr/portail/jcms/c_1731777