Mauna Kea Technologies Announces Ground-Breaking Positive Clinical Results in Lung Cancer Obtained with Cellvizio

Mauna Kea Technologies Announces Ground-Breaking Positive Clinical Results in Lung Cancer Obtained with Cellvizio

Recent clinical study published in Journal of Thoracic Disease supports the combination of Cellvizio with Electromagnetic Navigation Bronchoscopy to improve diagnosis and treatment of lung cancer

Cellvizio’s sensitivity of 96.43% and specificity of 100% in characterizing malignancies enabled higher diagnostic yield and radiation-free nodule marking for surgical resection

Lung cancer remains the leading cause of cancer-related deaths worldwide with 2.5 million new cases annually

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 the publication1 in the peer-reviewed Journal of Thoracic Disease of new ground-breaking clinical results demonstrating the efficacy of its needle-based Confocal Laser Endomicroscopy (nCLE) technology for the characterization of peripheral lung cancer and preparation of surgical resection.

This study, conducted by the team of Professor Stéphane Renaud at the University Hospital of Nancy, evaluated the use of Cellvizio’s nCLE platform in combination with Electromagnetic Navigation Bronchoscopy (ENB) to characterize suspicious pulmonary nodules and prepare them for surgical resection when needed. The results highlight the potential of nCLE to rapidly and accurately identify malignant lesions while minimizing the risks associated with traditional diagnostic methods including ionizing radiation.

The study included 30 patients with suspicious pulmonary nodules with a median size of 16 mm. The findings revealed a sensitivity of 96.43% and a specificity of 100% in characterizing malignant lesions, based on previously published nCLE image classification. The median time of contact with the suspicious lesions was just 5 minutes with no major complications reported, demonstrating the technology's efficiency in clinical practice. Additionally, the use of nCLE also improved the quality and quantity of tissue sampling, thus enabling molecular and genomics analyses, which have become essential tools for the choice and planning of treatments.

Professor Stéphane Renaud, Thoracic Surgeon at University Hospital Nancy and principal investigator of the study, stated: "We are extremely pleased with the results of this study, which brings to light the high diagnostic value of needle-based endomicroscopy in combination with Electromagnetic Navigation Bronchoscopy and its ability to improve our treatment planning and minimize patient risk. With a much-enhanced ability to target our biopsies, we have also been able to obtain essential tissue material for molecular and genomics analyses, which are crucial for guiding immunotherapy strategies. This combination of technologies will certainly play a key role in the fight against lung cancer in the future.”

"We are thrilled by these outstanding clinical results, which reinforce the value of our needle-based endomicroscopy platform in advancing the field of lung cancer diagnostics and treatment,” commentedSacha Loiseau, Ph.D., Chairman and CEO of Mauna Kea Technologies. “This study confirms that Cellvizio® can play a pivotal role not only in enabling real-time, accurate, and minimally invasive diagnosis, but also in helping physicians improve their treatment planning and, in turn, patient outcomes."

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.

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1 “Assessment of needle-based confocal laser endomicroscopy (nCLE) as a tool for real-time diagnosis of non-small cell lung cancer”https://jtd.amegroups.org/article/view/89316/html

Mauna Kea Technologies
investors@maunakeatech.com

NewCap - Investor Relations
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maunakea@newcap.eu

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