Mauna Kea Technologies Announces Endorsement from The American Foregut Society for Payor Policy Coverage of Cellvizio®

Business Wire

Formal letter requests coverage of Cellvizio and its dedicated category I CPT Codes to significantly enhance early detection of Barrett’s Esophagus and Esophageal Cancer

Prevalence of Esophageal Cancer has increased more than 600%¹ in the past two decades, causing serious concern among gastroenterologists and foregut surgeons

PARIS & BOSTON--(BUSINESS WIRE)--
Regulatory News:

Mauna Kea Technologies (Euronext Growth: ALMKT), inventor of Cellvizio®, the multidisciplinary probe and needle-based confocal laser endomicroscopy (p/nCLE) platform, today announces that the American Foregut Society (AFS), a leading society of gastroenterologists and surgeons collaborating to improve patient outcomes of several conditions, including esophageal disease, has formally requested that health insurance providers update their medical coverage policies to include Cellvizio and confocal laser endomicroscopy (CLE) as a covered service.

The letter, available on the society website, provides details about the grim realities of currently covered tools and technologies for the early detection of precancerous conditions like Barrett’s Esophagus (BE) and cancerous conditions like Esophageal Cancer (EAC), and how those tools fail to enhance early detection, resulting in a dramatic rise in the prevalence of EAC over the past 20 years. The AFS outlines the strong clinical data supporting the use of Cellvizio as a safe and highly effective detection tool when used adjunctively during a standard endoscopy procedure and reiterates that its society members advocate for the clinical use of Cellvizio and strongly request coverage by payors.

“We are confident that expanding access to the Cellvizio procedure (CLE) will empower providers with an essential tool for upper endoscopy (EGD) that enables the early detection of BE and EAC,” says Reginald Bell, M.D., FACS, the Chair of the AFS Board, on behalf the society. “Evaluation of Barrett’s esophagus to identify pre-cancerous changes and early cancer requires careful, detailed evaluation of the full extent of the Barrett’s mucosa. By the time obvious visible changes occur, advanced cancer is typically found. Early detection with Cellvizio is fully aligned with the mission of the American Foregut Society, and we urge consideration of immediate coverage of the Cellvizio procedure.”

Sacha Loiseau, Ph.D., Chairman and CEO of Mauna Kea Technologies, commented: “The AFS is the leading society which brings renowned gastroenterologists and foregut surgeons together under a common mission focused on esophageal cancer and other diseases of the foregut. Since its founding, AFS has advocated on behalf of patients and the providers who deliver their medical care, with the goal of preventing continued advancement of deadly diseases like esophageal cancer. The lack of payor coverage remains the number one barrier preventing patients from having broad access to better detection of early pre-cancerous changes in their esophagus, which could save them from future esophageal cancer. On behalf of the millions of patients suffering from reflux disease, we are thankful for this endorsement and advocacy from the AFS and look forward to working with payors to expand further the coverage of Cellvizio, ultimately broadening patient access to our breakthrough imaging platform.”

***

About Mauna Kea Technologies

Mauna Kea Technologies is a global medical device company that manufactures and sells Cellvizio®, the real-time in vivo cellular imaging platform. This technology uniquely delivers in vivo cellular visualization which enables physicians to monitor the progression of disease over time, assess point-in-time reactions as they happen in real time, classify indeterminate areas of concern, and guide surgical interventions. The Cellvizio® platform is used globally across a wide range of medical specialties and is making a transformative change in the way physicians diagnose and treat patients. For more information, visit www.maunakeatech.com.

Disclaimer

This press release contains forward-looking statements about Mauna Kea Technologies and its business. All statements other than statements of historical fact included in this press release, including, but not limited to, statements regarding Mauna Kea Technologies' financial condition, business, strategies, plans and objectives for future operations are forward-looking statements. Mauna Kea Technologies believes that these forward-looking statements are based on reasonable assumptions. However, no assurance can be given that the expectations expressed in these forward-looking statements will be achieved. These forward-looking statements are subject to numerous risks and uncertainties, including those described in Chapter 2 of Mauna Kea Technologies' 2023 Annual Report filed with the Autorité des marchés financiers (AMF) on April 30, 2024, which is available on the Company's website (www.maunakeatech.fr), as well as the risks associated with changes in economic conditions, financial markets and the markets in which Mauna Kea Technologies operates. The forward-looking statements contained in this press release are also subject to risks that are unknown to Mauna Kea Technologies or that Mauna Kea Technologies does not currently consider material. The occurrence of some or all of these risks could cause the actual results, financial condition, performance or achievements of Mauna Kea Technologies to differ materially from those expressed in the forward-looking statements. This press release and the information contained herein do not constitute an offer to sell or subscribe for, or the solicitation of an order to buy or subscribe for, shares of Mauna Kea Technologies in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. The distribution of this press release may be restricted in certain jurisdictions by local law. Persons into whose possession this document comes are required to comply with all local regulations applicable to this document.

__________________________________

¹ Hang, Thuy-Van P., et al. “The Epidemiology of Esophageal Adenocarcinoma in the United States: Presidential Poster Award: 333.” The American Journal of Gastroenterology, vol. 113, no. Supplement, Wolters Kluwer Health Medical Research, Lippincott Williams & Wilkins, 2018, pp. S185–S186.