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Mauna Kea Technologies — Investor Relations & Filings

Ticker · MKEA ISIN · FR0010609263 LEI · 5493007KMDG4MFIGJJ63 PA Manufacturing
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Filings indexed 774 across all filing types
Latest filing 2017-09-05 Regulatory Filings
Country FR France
Listing PA MKEA

About Mauna Kea Technologies

https://www.maunakeatech.com/en/

Mauna Kea Technologies is a medical device company that develops and markets the Cellvizio® platform, a real-time in vivo cellular imaging system. The platform utilizes Confocal Laser Endomicroscopy (CLE) technology, enabling physicians to visualize tissue at the cellular level during medical procedures. This "optical biopsy" is performed using flexible, miniature fiber-optic probes (Confocal Miniprobes™) that are compatible with standard endoscopes. The core function of Cellvizio® is to provide immediate microscopic visualization, which aids in accelerating diagnosis, informing treatment strategies, and improving the precision of therapeutic interventions. Key applications include gastroenterology (for conditions such as Barrett's esophagus and pancreatic cysts), interventional pulmonology (lung cancer diagnostics), urologic oncology, and neurosurgery. The technology supports enhanced surgical procedures, including real-time margin assessment, and is being integrated with robotic surgery and AI-assisted imaging systems.

Recent filings

Filing Released Lang Actions
Communiqués au titre de l'obligation d'information permanente / Autres communiqués
Regulatory Filings Classification · 95% confidence The document is a press release dated September 5, 2017, announcing the global launch of the Cellvizio product in Urology by Cook Medical, as part of a strategic partnership with Mauna Kea Technologies. It discusses market potential, regulatory approvals (FDA), and strategic collaboration. This type of announcement, detailing a significant business development, partnership execution, or product launch update, does not fit neatly into the specific financial reporting categories (10-K, IR, ER, etc.). It is a general corporate announcement regarding business operations and market strategy. Since it is not a specific financial report, a management discussion, a capital event, or a director dealing, the most appropriate fallback category is Regulatory Filings (RNS) for general corporate news that doesn't fit elsewhere, although it strongly resembles an Investor Presentation (IP) or Management Report (MDA) in content structure, it lacks the formal structure of those filings. Given the options, RNS serves as the best general corporate announcement category for non-standard news releases.
2017-09-05 French
Communicated under the obligation to provide permanent information / Other communications
Report Publication Announcement Classification · 99% confidence The document is titled with a company name and an announcement regarding its presence at a scientific conference ('Mauna Kea Technologies Announces Strong Presence of Cellvizio at the OESO 14th World Conference'). It is dated August 31, 2017, and contains quotes from the CEO, details about presentations, and contact information for investor relations. This structure is characteristic of a press release announcing business or product updates, which typically falls under the general category of Regulatory Filings (RNS) if no more specific category applies. It is not a formal financial report (10-K, IR, ER, MRQ), a management change (MANG), or a shareholder vote result (DVA). Since it is a general announcement about business activity and product promotion, the most appropriate classification is Regulatory Filings (RNS), as it is a broad announcement that doesn't fit the highly specific financial or governance categories.
2017-08-31 English
Communiqués au titre de l'obligation d'information permanente / Autres communiqués
Regulatory Filings Classification · 95% confidence The document is a press release from Mauna Kea Technologies announcing the strong presence of its product, Cellvizio, at the 14th World Congress of the OESO (Esophageal Diseases). It details specific presentations, dates, and speakers related to the product's application in gastroenterology. This type of announcement, focusing on participation in an industry event or conference where product data/use cases are presented, is best classified as an Investor Presentation (IP) if it were the presentation itself, or more generally, a communication aimed at investors and the market about company activities. Since it is an announcement *about* presentations at a conference, and not a formal regulatory filing (like 10-K or ER), nor a transcript (CT), it aligns best with general investor communication. However, given the options, it is a specific announcement about company activities and product promotion, which often falls under Investor Presentation (IP) if it were the deck, or sometimes Regulatory Filings (RNS) if it's a general market disclosure. Since it is a detailed announcement of scientific/clinical engagement, it is closer to an Investor Presentation (IP) or a general Regulatory Filing (RNS). Given the content focuses on scientific/clinical updates being shared at a major event, IP is a strong candidate, but RNS is the safest general disclosure category for non-standard announcements. Let's re-evaluate the definitions. It is not a formal financial report (10-K, IR, ER, MRQ). It is not a management change (MANG) or dividend (DIV). It is an announcement of company activity. Since it details specific scientific sessions and future adoption efforts, it functions as an update to investors about market penetration and clinical validation. If it were a presentation deck, it would be IP. As a press release detailing this, RNS (Regulatory Filings/General Announcement) is the most appropriate fallback for non-standard disclosures, though IP is conceptually close. Given the context of a press release detailing clinical/scientific engagement, I will classify it as RNS as it is a general market announcement that doesn't fit the highly specific financial/corporate action codes.
2017-08-31 French
Communiqués au titre de l'obligation d'information permanente / Activité de l'émetteur (acquisitions, cessions, partenariats, …)
Legal Proceedings Report Classification · 99% confidence The document is a press release dated August 7, 2017, announcing that Mauna Kea Technologies obtained a specific FDA clearance (510(k)) for its Cellvizio system for use in robotic surgery procedures. This type of announcement, detailing a regulatory milestone, product update, or business development, is typically classified as a general regulatory announcement or news release. Since it is not a full financial report (10-K, IR), an earnings release (ER), a management discussion (MDA), or a specific capital/financing event (CAP), the most appropriate category is the general regulatory filing/announcement fallback, RNS (Regulatory Filings), as it communicates a significant regulatory event to the market. The document length is relatively short (under 5,000 characters) and functions as an announcement rather than the detailed report itself.
2017-08-07 French
Communicated under the obligation to provide permanent information / Activity of the issuer (acquisition, sale, partnerships, etc.)
Regulatory Filings Classification · 90% confidence The document is a press release dated August 7, 2017, announcing that Mauna Kea Technologies received U.S. FDA 510(k) clearance for its CelioFlex UHD Confocal Miniprobes for use in robotic-assisted surgery. This type of announcement, detailing a specific regulatory clearance or approval that impacts the company's operations or product line, does not fit neatly into the primary financial reporting categories (10-K, IR, ER, MRQ). It is a specific, material corporate event announcement. Since it is not a general regulatory filing (RNS) but a specific announcement about a regulatory milestone, and it doesn't fit the other specific categories (like M&A, Dividend, Management Change), the most appropriate classification is the general 'Regulatory Filings' (RNS) as a catch-all for significant, non-standard announcements, or potentially 'LTR' if viewed as a regulatory matter, but RNS is better suited for general positive regulatory news that isn't a lawsuit. Given the options, RNS serves as the best fit for a specific regulatory clearance announcement that isn't a core financial report or a management/shareholder event.
2017-08-07 English
Communicated under the obligation to provide permanent information / Other communications
Regulatory Filings Classification · 90% confidence The document is titled as an announcement: "MAUNA KEA TECHNOLOGIES ANNOUNCES PEER-REVIEWED PUBLICATION OF KEY MULTICENTER RANDOMIZED CONTROLLED TRIAL...". It details the results of a clinical study published in the journal *Endoscopy*. This is a press release announcing the publication of scientific/clinical data, not the full financial report (10-K, IR), a management discussion (MDA), or the earnings release (ER). Since it is an announcement about a specific type of report (a clinical publication) and not a standard regulatory filing like a 10-K or a general regulatory notice (RNS), it best fits the category for general announcements or press releases that don't fit other specific categories. Given the options, 'Regulatory Filings' (RNS) is the most appropriate fallback for a press release announcing a clinical publication, as it is not an Earnings Release (ER), Interim Report (IR), or a specific legal/governance document. However, looking closely at the definitions, none perfectly capture a 'Clinical Publication Announcement'. Since it is a formal announcement of results/data, and not a financial report, RNS (Regulatory Filings/General Announcement) is the best fit among the provided codes for a non-financial, non-governance press release.
2017-08-02 English

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