Regulatory News:
Dear Shareholders and Investors,
November is Pancreatic Cancer Awareness Month. It highlights a major public health challenge that concerns us all: with the widespread use of cross-sectional imaging (CT and MRI), pancreatic cyst lesions are now detected by chance in 3% to 10% of adults. For both physicians and patients, the critical challenge is to reliably distinguish benign cysts-to avoid unnecessary major surgery-from cysts that may progress to pancreatic cancer.
In this key indication, Mauna Kea Technologies (Euronext Growth: ALMKT) provides a concrete answer with Cellvizio. By enabling physicians to observe the inner wall of the cyst in real time at the cellular level during an endoscopic procedure, our technology is increasingly establishing itself as a clinical standard of care, backed by landmark multicenter clinical studies, medical society guidelines, and an established reimbursement framework in the United States, our largest market.
To help you better understand what we do and visualize how this clinical application works in practice, we are pleased to share a new dedicated interactive page in our Investor Relations section:
- Explore our interactive page (English Version)
To go further on this indication:
- Leading U.S. clinical research: You can visit the new website of Professor Somashekar Krishna's Lab at The Ohio State University-one of the world's foremost experts in pancreatic cyst endomicroscopy-presenting ten years of clinical outcomes:
Visit the Krishna Lab website (Ohio State University) - Clinician perspective (Podcast): You can also listen to Dr. Anjuli Luthra on the U.S. medical podcast Medical Design Briefs ("Earlier, More Accurate Detection of Pancreatic Cancer"):
Listen on Spotify Listen on Apple Podcasts Episode page on Medical Design Briefs
About Mauna Kea Technologies
Mauna Kea Technologies is a global medical device company that develops and markets Cellvizio, an imaging platform that enables real-time, cellular visualization of tissue during a routine medical examination. Cellvizio is gradually establishing itself as the gold standard for assessing the risk of malignancy of pancreatic cystic lesions, thereby avoiding unnecessary surgeries, for detecting Barrett's esophagus-a condition that can progress to esophageal cancer-and for identifying food intolerances by directly observing the intestinal barrier. Approved in more than 40 countries, including the United States, Europe, Japan and China, it has been used in more than 110,000 patients, has been the subject of more than 1,200 clinical publications, and is covered under Category I reimbursement codes in the United States. For more information, visit www.maunakeatech.com.
Regulatory Disclaimer Safety Information: Research at The Ohio State University is supported in part by a grant from Mauna Kea Technologies. This shareholder communication presents previously published clinical and financial data and contains no new inside financial information within the meaning of Regulation (EU) No 596/2014 (MAR). It does not constitute an offer or recommendation to invest, medical advice, or direct-to-consumer promotional material. Cellvizio systems and AQ-Flex 19 miniprobes are prescription devices restricted to use by trained healthcare professionals strictly within cleared indications (CE Mark FDA 510(k)). As with any interventional endoscopic ultrasound procedure involving fine-needle puncture (EUS-FNA) and intravenous administration of a contrast agent (fluorescein sodium), the procedure carries inherent risks (including acute pancreatitis, bleeding, infection, or hypersensitivity reactions to fluorescein) detailed in the device Instructions for Use (IFU).
View source version on businesswire.com: https://www.businesswire.com/news/home/20261111008770/en/
Contacts:
Mauna Kea Technologies
investors@maunakeatech.com
NewCap Investor Relations
Thomas Grojean
+33 (0)1 44 71 94 94
maunakea@newcap.eu
