Mauna Kea Technologies Expands Presence in the Middle East with UAE and Turkey Regulatory Approvals and First CellTolerance® Commercial Installation

IBS-related symptom prevalence in the region is among the highest in the world, reaching an average of 27%

An ideal region uniquely positioned for CellTolerance®’s direct out-of-pocket commercial expansion

First sales confirmed in UAE this quarter

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 a significant milestone in its international expansion, driven by official regulatory approvals in both the United Arab Emirates (UAE) and Turkey, alongside the first commercial sales for CellTolerance® in the region. These authorizations enable the full-scale launch of the CellTolerance® program in a region characterized by a record prevalence of disorders of the gut-brain interaction or DGBI.

The Middle East stands as a significant commercial growth driver for Mauna Kea Technologies, given the region's exceptionally high rates of Irritable Bowel Syndrome (IBS) and food intolerances. In the UAE and the Arab World, a 2024 systematic review highlights an average IBS prevalence of 27% across the region¹, with specific demographics such as young adults in the UAE reporting symptoms in up to 39% of the population². These figures, driven by rapid lifestyle changes, dietary shifts, and high stress levels, create a massive demand for precise diagnostic tools, positioning CellTolerance as a critical test in the patient workflow.

The Emirates Drug Establishment (EDE) and the Turkish Medicines and Medical Devices Agency (TITCK) have granted official market authorization for the Cellvizio Gen 3 system and its specialized suite of probes. Building immediately on these approvals, Mauna Kea Technologies has secured its first commercial sale of Cellvizio in the UAE dedicated specifically to the CellTolerance® program. The Company and its distribution partners are actively advancing a pipeline of additional commercial prospects across the region.

The international rollout of CellTolerance® is driven by a direct "cash-pay" (out-of-pocket) commercial strategy, which is well-suited to the Middle Eastern healthcare landscape. This region is characterized by a thriving premium private healthcare sector and a patient demographic with strong purchasing power that actively seeks personalized, cutting-edge medical innovations.

Sacha Loiseau, Ph.D., Chairman and CEO of Mauna Kea Technologies commented: "The international expansion of Cellvizio and the CellTolerance test for food intolerances is gaining momentum, following our successful entries into Switzerland and the United Kingdom in the first quarter. The UAE and Turkey are highly promising markets for CellTolerance, where personalized medicine is a major priority and IBS and suspected food intolerance represents a critical public health challenge with some of the highest prevalence rates in the world. With CellTolerance, we are bringing a concrete solution to millions of patients who have been caught in a cycle of diagnostic uncertainty."

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' 2025 Annual Report filed with the Autorité des marchés financiers (AMF) on April 30, 2026, 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 Almansour O. "Prevalence of Irritable Bowel Syndrome (IBS) in the Arab World: A Systematic Review." Cureus. 2024 Jul 26;16(7):e65421.
² Irritable Bowel Syndrome, Eating Disorders, and Mental Stress Among United Arab Emirates University Students.” Scholarworks@UAEU.