Aankondiging • Jun 02
Mauna Kea Technologies Announces Major AI Breakthrough with Cellvizio in Pancreatic Cystic Lesion Risk Stratification Mauna Kea Technologies announced a significant advancement with the results of a landmark study published in the peer-reviewed journal Pancreatology. The research, titled “Towards Automating Risk Stratification of Intraductal Papillary Mucinous Neoplasms: Artificial Intelligence Advances Beyond Human Expertise with Confocal Laser Endomicroscopy”, demonstrates that Artificial Intelligence (AI) model combined with Cellvizio needle-based confocal laser endomicroscopy (nCLE) technology significantly outperforms human experts in risk stratification of Intraductal Papillary Mucinous Neoplasms (IPMNs), a common type of pancreatic cyst. The study aimed to compare the performance of 16 nCLE human experts with a novel AI algorithm (nCLE-AI) specifically designed for the sub-classification of a type of pancreatic cystic lesion with malignant potential. These findings build on the CLIMB study data presented this year at DDW, which demonstrated strong diagnostic performance of needle-based confocal laser endomicroscopy in differentiating benign from malignant or pre-malignant pancreatic cysts. Indeed, the latest results from the CLIMB study -spanning 17 endosonographers across 14 centers - have further reinforced the significantly superior diagnostic accuracy of Endoscopic Ultrasound-guided nCLE (EUS-nCLE) compared to the current standard of care. The results of the study on risk stratification associated with IPMNs cysts with malignant potential, detailed in the table below, show that the nCLE-AI model combined with revised Fukuoka Criteria achieves an Area Under the Curve (AUC) of 0.85, with a sensitivity of 78% and a specificity of 78%. This performance is significantly superior to that of human experts using the same criteria (AUC 0.64; p<0.01) and represents an improvement over the nCLE-AI model alone (p=0.02), clearly demonstrating the superiority of the AI-augmented approach for enhancing the detection of malignant cysts that need immediate intervention. The AI model continues to improve rapidly with additional nCLE sequences and data. The prevalence of pancreatic cystic lesions in the adult asymptomatic population ranges from 2.4% to 24.3%. The large majority of pancreatic cystic lesions are discovered through incidental imaging, and it is estimated that 40% of cysts with no risk of carcinogenesis are operated on unnecessarily. More accurate classification methods, including risk stratification, are therefore needed earlier in the patient’s diagnostic workup. Conventional diagnostic testing involves performing an endoscopic ultrasound (EUS) and then collecting and testing the cyst fluid through fine needle aspiration (FNA). In some advanced facilities, next generation sequencing (NGS) of cellular DNA may be performed to provide additional data. Although most facilities employ a combination of a range of conventional diagnostic methods, sensitivity, specificity, and accuracy remain insufficient, potentially exposing patients to misclassified cysts and unneeded surgical procedures. Aankondiging • Mar 04
Mauna Kea Technologies's Cellvizio Now Recommends in New European Society of Gastrointestinal Endoscopy Technical Guideline for Pancreatic Cyst Diagnosis Mauna Kea Technologies announced that the European Society of Gastrointestinal Endoscopy (ESGE) has issued a recommendation for the use of needle-based confocal laser endomicroscopy (nCLE) with Cellvizio®? for the characterization of pancreatic cyst lesions (PCLs)1. This recognition highlights the potential of nCLE to enhance the accuracy of pancreatic cyst diagnoses in centers with adequate expertise, supporting its integration into standard clinical practice. ESGE suggests the use of nCLE to differentiate between mucinous and non-mucinous pancreatic cysts, acknowledging the technology's ability to provide real-time, high-resolution imaging of tissue and vascular structures. The recommendation is based on a large body of clinical evidence demonstrating nCLE's diagnostic accuracy compared to conventional endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) alone. Several multi-center studies have reported high diagnostic accuracy with nCLE, including one study presented at Digestive Disease Week®? 2024 demonstrating very high sensitivity and diagnostic accuracy of EUS-nCLE for classifying mucinous vs. non-mucinous PCLs of 98% and 97%, respectively, compared to 77% and 80% for CEA +cytology + glucose. Additionally, cost-benefit analyses demonstrate that integrating nCLE into PCL management reduces unnecessary surgeries by 23% and decreases overall clinical costs by 13%. This recognition from ESGE marks a turning point, underscoring the critical role that nCLE with Cellvizio can play in transforming pancreatic cyst diagnosis. For patients, this means fewer unnecessary surgeries on indeterminate cysts, faster and more accurate diagnoses, and ultimately better outcomes. For healthcare providers, integrating nCLE into routine practice represents a major leap forward in precision medicine. With pancreatic cysts affecting millions worldwide and current diagnostic tools leaving too much uncertainty, this recommendation paves the way for large-scale deployment and will be a key driver in securing reimbursement across several countries. 2025 is off to a strong start and is set to be a milestone year for this indication. Some highly anticipated results from the CLIMB study - the largest clinical study for this indication - conducted in 14 centers in the United States, set to be unveiled at Digestive Disease week®? 2025, will definitively establish technology as the gold standard worldwide for pancreatic cyst characterization. Aankondiging • Jan 28
Mauna Kea Technologies Announces Promising Results in New Application Combining Robotics and Cellvizio®? for Precision Surgery in Head and Neck Cancers Mauna Kea Technologies announced 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. 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. Aankondiging • Jan 16
Mauna Kea Technologies SA, Annual General Meeting, Jun 05, 2025 Mauna Kea Technologies SA, Annual General Meeting, Jun 05, 2025. Aankondiging • Oct 17
Mauna Kea Technologies Announces New Positive Clinical Results for Cellvizio in Food Intolerance Mauna Kea Technologies announced that new clinical data demonstrating the value of Cellvizio® in the detection, understanding, and treatment of food intolerances leading to gut barrier dysfunction in patients suffering from Irritable Bowel Syndrome (IBS), were presented at UEG Week 2024, the world's largest gastroenterology congress. In this study, 119 patients suffering from IBS were screened using Cellvizio® during a food challenge to detect primary and food-induced gut barrier dysfunctions. Of these patients, 62% showed a response to a food challenge in the form of an impaired intestinal barrier. Patients with identified dysfunctions were treated with a multimodal approach, including an elimination diet of the problematic foods identified by the unique imaging provided by Cellvizio®. After approximately six months, 71% of patients who returned for a follow-up procedure using Cellvizio® showed improvement in barrier integrity, with 46% achieving full stabilization. Clinical outcomes included significant improvements in IBS severity, quality of life, and psychological well-being, with particular relief from abdominal pain, cramping, and stool irregularities. Aankondiging • Oct 16
Mauna Kea Technologies Sa Reaffirms Sales Guidance for the Year 2024 Mauna Kea Technologies SA reaffirmed sales guidance for the year 2024. 2024 guidance set over +20% organic sales growth, excluding licensing income. Aankondiging • Sep 16
Mauna Kea Technologies Announces Positive Clinical Results in Lung Cancer Obtains with Cellvizio Mauna Kea Technologies announced the publication 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 Stephane 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. Aankondiging • Jul 26
Mauna Kea Technologies SA to Report First Half, 2024 Results on Oct 30, 2024 Mauna Kea Technologies SA announced that they will report first half, 2024 results on Oct 30, 2024 Aankondiging • Apr 27
Mauna Kea Technologies SA Provides Sales Guidance for the Year 2024 Mauna Kea Technologies SA provided sales guidance for the year 2024. 2024 guidance set over +20% organic sales growth, excluding licensing income. Aankondiging • Dec 22
Mauna Kea Technologies SA ADR - Sponsored to Be Deleted from OTC Equity Mauna Kea Technologies SA American Depositary Receipts - Sponsored (France) will be deleted from OTC Equity effective December 21, 2023, due to ADR /GDR Program Terminated. Aankondiging • Nov 14
Mauna Kea Technologies SA announced that it expects to receive €6 million in funding from Telix Pharmaceuticals Limited Mauna Kea Technologies SA announced a private placement of 11,911,852 common shares at a price of €0.5037 per share for gross proceeds of €6,000,000 on November 13, 2023. The transaction included participation from new investor Telix Pharmaceuticals Limited. Aankondiging • Nov 02
Mauna Kea Technologies Announces First Patient Enrolled in the Pivotal CLEVER Clinical Trial in Peripheral Lung Cancer Mauna Kea Technologies announced the first patient enrollment in the multi-center randomized controlled trial (RCT) entitled "Confocal Laser Endomicroscopy VERification" (CLEVER, NCT06079970)1 in collaboration with the Amsterdam University Medical Centers (UMC) for the diagnosis and management of peripheral lung lesions. In the framework of this trial, over 200 patients will be enrolled across 7 sites in Europe and the U.S. until end of second quarter 2025. Lung cancer is the world's leading cause of cancer deaths claiming over 1.8 million lives every year - more than colorectal, breast, and prostate cancers combined. The rise in lung cancer screening and 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. Over 80% of these incidental lesions develop in the peripheral bronchi and are not easily visualized or accessed during conventional bronchoscopy. Adding nCLE as an adjunctive technique offers a potential solution by providing real-time feedback on the correct positioning of biopsy twazers or needles (tool-in-lesion) and collecting the right cells samples (lesion-in-tool). Aankondiging • Sep 19
Mauna Kea Technologies and Endoscopy Institute of Hawaii Achieve 1,200 Procedure Milestone Mauna Kea Technologies announced that Jeong Kim, M.D., and the Endoscopy Institute of Hawaii (EIH) clinical team have completed more than 1,200 Cellvizio procedures for the diagnosis and interventional treatment of gastric disease, a condition which can lead to gastric cancer. EIH is part of the Covenant Physician Partners network of facilities and physicians which operates more than 85 leading healthcare centers across the United States. Dr. Kim, the lead gastroenterologist at EIH, is a specialist providing care for a broad range of digestive illnesses such as detection of stomach and colon cancer, gastroesophageal reflux disease (GERD), inflammatory bowel disease (IBD), and liver disease. His focus on minimally invasive endoscopy led Dr. Kim to add the Cellvizio program to his facility in January 2020. Since then, he has used Cellvizio on more than 1,200 patients, primarily for the screening and detection of GIM, which is a known precursor to gastric cancer and is highly prevalent in certain populations such as patients of Asian descent and among patients with specific risk factors like diet, lifestyle, or family history of gastric disease. Mapping GIM is a burdensome clinical challenge, given the large size of the stomach and the need to adequately visualize the gastric mucosa to rule out suspicious lesions and determine GIM extent. Dr. Kim has developed his own adjunctive protocol used in tandem with the standard protocol to provide the best care to his patients. His total procedure time takes only 10 to 12 minutes for a full visual inspection with Cellvizio, including completing multiple gastric biopsies using the Sydney Protocol. Aankondiging • Jan 13
Mauna Kea Technologies SA Announces the Publication of Results of the First in Human Clinical Study Combining Robotic-Assisted Bronchoscopy and Needle-Based Confocal Laser Endomicroscopy for Lung Cancer Mauna Kea Technologies SA announced that the results of the first in human clinical study combining nCLE and robotic-assisted bronchoscopy (Clinicaltrials.gov: NCT04441749) have been published in the international peer-reviewed journal Respirology(1) . This clinical study, co-funded by the Lung Cancer Initiative at Johnson & Johnson(2), combines needle-based confocal laser endomicroscopy and robotic-assisted bronchoscopy using both Cellvizio(R) and the Monarch(TM) Platform from Ethicon(3) for the diagnosis of peripheral lung nodules. Twenty patients with a median lung nodule size of 14.5mm (range 8-28mm) were enrolled. This study demonstrated that robotic-assisted bronchoscopic nCLE-imaging in small peripheral lung lesions is feasible and safe and provides real-time feedback on correct needle positioning. Bronchoscopic nCLE-imaging provided tool-in-nodule confirmation in 19 of 20 patients (95%) whereas corresponding rapid on-site evaluation (ROSE) confirmed representative material in only 9 of 20 patients (45%) and no complications were reported during the study. With nCLE real-time in vivo cellular imaging feedback, the needle was repositioned in 45% of the patients (9/20 patients) to reach a diagnostic yield across all nodule sizes and locations of 80%. Of the 17 patients with malignancy, 16 (94%) had the final diagnosis of lung cancer confirmed by nCLE imaging, including two patients with negative TBNA and biopsies. 
