Mauna Kea Technologies Announces Approval from the American Foregut Society for Cellvizio Payment Policy Coverage Page 1

Regulatory News:

Mauna Kea Technologies (Euronext Growth: ALMKT)The inventor of Cellvizio, the multidisciplinary probe- and needle-based confocal laser endomicroscopy (p/nCLE) platform, today announced that the American Foregut Society (AFS), a leading society of gastroenterologists and surgeons working together to improve patient outcomes for a variety of conditions, including esophageal diseases, has formally requested that health insurers amend their medical coverage policies to include Cellvizio and confocal laser endomicroscopy (CLE) as a covered service.

The letter, available on the association’s website, details the stark reality of currently covered devices and technologies for the early detection of precancerous conditions like Barrett’s esophagus (BE) and cancerous conditions like esophageal cancer (EAC), and how those devices have failed to improve early detection, resulting in a dramatic increase 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 members advocate for the clinical use of Cellvizio and urge its coverage by payers.