Regulatory News:

Mauna Kea Technologies (Euronext Growth: ALMKT) (Paris:ALMKT), inventor of Cellvizio®, the multidisciplinary probe and needle-based confocal laser endomicroscopy (p/nCLE) platform, today announced the opening of a French Center of Excellence for the use of Cellvizio in lung cancer diagnostics. The Cellvizio procedure is now performed preoperatively by Prof. Stéphane Renaud, MD, PhD, a leading thoracic surgeon at the University Hospital (CHRU) in Nancy, France. This initiative is part of a global strategic expansion plan to establish Centers of Excellence in established and emerging clinical indications in several countries.

The rise in lung cancer screening coupled with the increased use of chest-computed tomography (CT) has generated a surge in the detection of suspected malignant lung lesions globally, increasing the need for more effective and efficient diagnostic methods. Given that over 80% of these incidental lesions develop in the peripheral bronchi, they pose a challenge to conventional bronchoscopy due to their difficult visualization and accessibility.

Combined with endobronchial navigation, Cellvizio improves bronchoscopy and allows simple, minimally invasive access to all areas of the lung, revealing the cellular architecture of tissues in real time. This direct visualization is a game-changer, because it enables instant guidance to be given, even for small lesions, without waiting for rapid cytology results, which are of very low diagnostic quality. This innovation not only reduces the length of procedures, but also improves diagnostic accuracy by enabling precise targeting of lesions and of biopsies, while providing greater safety for patients.

"In the field of cancer diagnosis, the precision of biopsy locations is essential. Traditional methods risk sampling from necrotic or merely inflammatory sites, leading to potentially misleading, false-negative results. Cellvizio's real-time visual inspection empowers us to target biopsies more accurately, focusing on areas that visually exhibit suspicious characteristics. This strategic approach significantly mitigates the risk of false negatives, ensuring a higher degree of diagnostic confidence” commented Professor Stéphane Renaud, MD, PhD, Department of Thoracic Surgery, Nancy Regional University Hospital, France.

"With the upcoming programs of lung cancer screening in Europe, there is a planned exponential growth of bronchoscopic examinations of patients with difficult to reach peripheral nodules that can lead to false negatives, additional unnecessary procedures and costs. Cellvizio has been proven to be a key addition to bronchoscopy in order to improve the physician’s ability to place biopsy tools precisely in the lesions and improve the overall diagnostic yield said Sacha Loiseau, Ph.D., Founder, Chairman and Chief Executive Officer of Mauna Kea Technologies. “We are very excited to have the University Hospital in Nancy serve as our Center of Excellence for Cellvizio in lung cancer diagnostics in France, another significant step forward in the scaling of the use of Cellvizio in the ever-expanding field of lung cancer diagnosis and treatment.”

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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.

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