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Mauna Kea Technologies — Investor Relations & Filings

Ticker · MKEA ISIN · FR0010609263 LEI · 5493007KMDG4MFIGJJ63 PA Manufacturing
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Filings indexed 780 across all filing types
Latest filing 2014-03-18 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 March 18, 2014, announcing that three French clinics have equipped themselves with the Cellvizio device from Mauna Kea Technologies. It details the expansion of the technology's availability and includes quotes from management and clinic directors. This type of announcement, focusing on business development, product adoption, and general company news, is characteristic of a general regulatory announcement or press release that doesn't fit the specific financial reporting categories (like 10-K, ER, IR) or corporate governance filings (like DEF 14A, DVA). Since it is a general announcement of a business event and does not fit any other specific category, the most appropriate classification is the general regulatory filing/announcement fallback category, RNS.
2014-03-18 French
Information relative au nombre total de droits de vote et d'actions composant le capital
Share Issue/Capital Change Classification · 95% confidence The document is dated March 10, 2014, and its title is "Information mensuelle relative au nombre total de droits de vote et d'actions composant le capital social" (Monthly information relating to the total number of voting rights and shares comprising the share capital). It explicitly references the French AMF (Autorité des Marchés Financiers) regulations and provides a table detailing the total number of shares and voting rights as of February 28, 2014. This content directly relates to the calculation and reporting of voting rights and share capital structure, which aligns best with the definition of 'Declaration of Voting Results & Voting Rights Announcements' (DVA), although it is a monthly update rather than a result of a specific meeting. Given the options, DVA is the most specific fit for reporting voting rights figures, even if it's a routine disclosure. It is not an AGM result (AGM-R), nor a general regulatory filing (RNS), as DVA is more specific to voting rights data.
2014-03-10 French
Communicated under the obligation to provide permanent information / Other communications
Regulatory Filings Classification · 95% confidence The document is an announcement from Mauna Kea Technologies regarding receiving a 510(k) regulatory clearance from the U.S. FDA for its Cellvizio product in urology. This type of announcement, detailing a specific regulatory milestone, legal/regulatory event, or business development that is not a standard periodic financial report (like 10-K, IR, or ER), fits best under the general category for regulatory announcements or specific legal/regulatory updates. Since it is a specific regulatory clearance announcement, it is not a general 'Regulatory Filing' (RNS) but rather a specific event update. Given the provided definitions, this is a report on a significant legal/regulatory event concerning product approval, which is closest to 'Legal Proceedings Report' (LTR) if interpreted broadly as regulatory action, or potentially 'Regulatory Filings' (RNS) as a catch-all for non-financial regulatory news. However, LTR is defined as 'Updates on significant lawsuits, regulatory actions, or legal matters involving the company.' An FDA clearance is a positive regulatory action. Since there is no specific code for 'Regulatory Approval Announcement', and it is a significant, non-financial regulatory event, RNS (General regulatory announcements and fallback category) is the most appropriate general classification, although LTR is a close second if focusing on the 'regulatory actions' aspect. Given the context of FDA clearance, RNS is the safest fallback for specific regulatory news not covered elsewhere.
2014-03-05 English
Communiqués au titre de l'obligation d'information permanente / Autres communiqués
Regulatory Filings Classification · 95% confidence The document is a press release dated March 5, 2014, announcing that Mauna Kea Technologies obtained the 510(k) regulatory authorization from the FDA for the use of its Cellvizio device in urology in the United States. This type of announcement, detailing a specific regulatory milestone, legal development, or significant business event that is not a standard periodic financial report (like 10-K or IR), typically falls under general Regulatory Filings (RNS) or potentially Legal Proceedings Report (LTR) if it were about a lawsuit, but here it is a positive regulatory clearance. Since there is no specific category for 'Regulatory Clearance Announcement' and it is not a financial report, an earnings release, or a management discussion, the most appropriate general category for a significant, non-financial regulatory update is Regulatory Filings (RNS). Given the document's nature as a formal announcement of a regulatory achievement, RNS is the best fit among the provided options, although it is not a 'miscellaneous' filing in the negative sense, but rather a specific type of regulatory news.
2014-03-05 French
Communicated under the obligation to provide permanent information / Other communications
Regulatory Filings Classification · 95% confidence The document is a press release announcing a specific business event: the installation of a medical device (Cellvizio system) at a hospital in India. It contains quotes from hospital staff and company executives, details about the technology, and contact information for investor relations. This type of announcement, which is not a formal regulatory filing like a 10-K, an earnings release (ER), or a dividend notice (DIV), fits best under the general category for miscellaneous corporate news or regulatory announcements that don't fit elsewhere. Given the options, 'Regulatory Filings' (RNS) serves as the best general catch-all for corporate news releases that aren't specifically about earnings, management changes, or capital structure, although 'LTR' (Legal Proceedings Report) or 'MANG' (Management Information) are clearly incorrect. Since it is a general corporate announcement/news release, RNS is the most appropriate fallback.
2014-02-19 English
Communiqués au titre de l'obligation d'information permanente / Autres communiqués
Regulatory Filings Classification · 95% confidence The document is a press release dated February 19, 2014, announcing that Mauna Kea Technologies has installed its Cellvizio system in an Indian hospital (Apollo Gleneagles). It details a business development achievement (a sale/installation) and includes quotes from management and hospital staff. This type of announcement, which is a general corporate update about business progress rather than a mandatory regulatory filing (like 10-K, ER, or DIV), best fits the category for general regulatory announcements or miscellaneous corporate news that doesn't fit a more specific financial or governance code. Given the options, 'Regulatory Filings' (RNS) serves as the best general catch-all for significant, non-standardized corporate news releases that are not explicitly about earnings, dividends, or management changes. It is not an Earnings Release (ER), a Call Transcript (CT), or a specific financial report (10-K, IR).
2014-02-19 French

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