Cellvizio was successfully integrated into TransOral Robotic Surgery (TORS) procedures to assess peripheral mucosal margins in the larynx, oropharynx and hypopharynx

Cellvizio helped identify occult disease and guided more precise resections, minimizing the need for excessive tissue removal

In a ground-breaking case series, surgeons achieved clean margins post-surgery in all cases thanks to Cellvizio imaging

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 very promising results in a new surgical indication published in a recent case series in Oral Oncology Reports. Surgeons at the University of Alabama at Birmingham (Birmingham, Alabama) have demonstrated the clinical feasibility and potential advantages of using the Cellvizio confocal laser endomicroscopy (CLE) platform during transoral robotic surgery (TORS) in combination with the da Vinci SP robotic surgical system by Intuitive to enhance the precision of margin assessment for head and neck cancers.

“This technology represents a paradigm shift in how we might assess surgical margins,” stated Dr. Bharat Akhanda Panuganti, an ENT surgeon and lead researcher. “We can visualize microscopic peripheral cancer margins in real time during surgery. We hope this advancement will maximize the likelihood of complete resection with precision, reducing the need for wide presumptive margins in highly susceptible anatomic regions, with the goal of maximizing patient functional outcomes.”

Head and neck cancers present unique surgical challenges, particularly in achieving clear margins while minimizing tissue loss to preserve critical functions such as swallowing and speech. Positive surgical margins – meaning cancer remains in the patient’s body after resection – occur in up to 15-20% of TORS procedures according to the study and are associated with a significantly increased risk of cancer recurrence.

The Cellvizio CLE platform directly addresses these challenges by providing high-resolution, real-time imaging of cellular structures and architecture. Cellvizio allows surgeons to visually delineate tumor boundaries intraoperatively, facilitating precise resection while sparing healthy tissue. This study focused on the application of Cellvizio in assessing mucosal margins during TORS for cancers of the larynx, hypopharynx and oropharynx.

Sacha Loiseau, Ph.D., Chairman and CEO of Mauna Kea Technologies commented: "This is yet another demonstration of the versatility and utility that our Cellvizio platform brings to robotic-assisted cancer surgery by enabling real-time, cellular-level insights to improve surgical precision and patient outcomes. Cellvizio not only addresses critical challenges like margin assessment but also offers a compelling opportunity for partners developing complementary technologies to integrate this innovation, enhancing their solutions and advancing the standard of care for patients worldwide."

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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.

Mauna Kea Technologies investors@maunakeatech.com

NewCap - Investor Relations Aurélie Manavarere / Thomas Grojean +33 (0)1 44 71 94 94 maunakea@newcap.eu

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