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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 2015-12-08 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
Mauna Kea Technologies Receives New Regulatory Approval for Cellvizio 100s in China
Regulatory Filings Classification · 100% confidence The document is a press release dated December 8, 2015, announcing that Mauna Kea Technologies received new regulatory approval from China's Food and Drug Administration (CFDA) for its Cellvizio 100s system for pancreatic and urologic applications. This is a specific announcement regarding regulatory clearance for a medical device, which is not covered by the primary financial filing types (10-K, IR, ER, etc.). It details a significant operational/regulatory milestone rather than financial results, management changes, or shareholder votes. Since it is a specific regulatory/operational announcement that doesn't fit the other defined categories (like M&A, Dividend, or Director's Dealing), the most appropriate general category is 'Regulatory Filings' (RNS), which serves as a fallback for miscellaneous regulatory announcements not covered elsewhere.
2015-12-08 English
MAUNA KEA TECHNOLOGIES OBTIENT L’AUTORISATION REGLEMENTAIRE EN CHINE POUR LA COMMERCIALISATION DU CELLVIZIO 100s
Regulatory Filings Classification · 100% confidence The document is a press release dated December 8, 2015, announcing that Mauna Kea Technologies obtained regulatory authorization (from CFDA) in China for the commercialization of its Cellvizio 100s system and associated probes for pancreatic and urological applications. This type of announcement, detailing a specific regulatory milestone or business development that is not a standard periodic financial report (like 10-K or IR) or a formal shareholder vote result, typically falls under general regulatory announcements or news releases. Since it is a specific, non-financial regulatory/business update that doesn't fit the other specific categories (like M&A, Capital Change, or Director Dealing), the most appropriate classification is Regulatory Filings (RNS), which serves as a broad category for such official announcements not covered elsewhere. The document length is short (3522 chars), but it is the full content of the announcement, not just a notice that a report is attached, thus ruling out RPA based on the 'MENU VS MEAL' rule interpretation for this context.
2015-12-08 French
Mauna Kea Technologies, World Premiere in Interventional Radiology: Tissue Ablation Monitored in Real-Time at Cellular Level
Regulatory Filings Classification · 90% confidence The document is a press release dated December 3, 2015, originating from PR Newswire, announcing clinical results and a world premiere in Interventional Radiology using Mauna Kea Technologies' Cellvizio platform. It details study results presented at the RSNA congress. This type of announcement, focusing on clinical/scientific updates, strategic validation, and general company news released via a wire service, does not fit neatly into the specific financial filing categories like 10-K, ER, or IR. It is a general corporate disclosure. Since it is not a specific report (like an Audit Report or Interim Report) but rather an announcement of scientific progress and validation of strategy, the most appropriate general category is 'Regulatory Filings' (RNS) as a catch-all for significant, non-standard disclosures, or potentially 'Investor Presentation' (IP) if it were a presentation deck, but given the format and source (PRNewswire), RNS is the best fit among the provided options for a general news disclosure.
2015-12-03 English
MAUNA KEA TECHNOLOGIES, PREMIERE MONDIALE EN RADIOLOGIE INTERVENTIONNELLE : ABLATION TISSULAIRE MONITORÉE EN TEMPS RÉEL AU NIVEAU CELLULAIRE
Regulatory Filings Classification · 95% confidence The document is a press release dated December 3, 2015, announcing a scientific presentation at the RSNA congress regarding the use of Mauna Kea Technologies' Cellvizio platform in interventional radiology procedures (biopsies and tumor ablations). It details clinical results, quotes key personnel (Prof. Gangi and CEO Sacha Loiseau), and provides contact information. The final line states, "Ceci est un communiqué d'informations réglementaires diffusé par PR Newswire" (This is a regulatory information release distributed by PR Newswire). Since this is an announcement of scientific/clinical progress and not a formal periodic financial report (like 10-K or IR), nor a specific corporate action like a dividend or management change, it fits best under the general category for regulatory announcements that don't fit elsewhere, which is Regulatory Filings (RNS). It is not an Earnings Release (ER) as it focuses on clinical data, not financial performance highlights.
2015-12-03 French
Mauna Kea Technologies awarded U.S. FDA clearance for use of cellvizio in minimally invasive surgery
Regulatory Filings Classification · 100% confidence The document is a press release announcing that Mauna Kea Technologies received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Cellvizio platform to be used in minimally invasive surgery. This type of announcement, detailing a regulatory approval or significant legal/regulatory event, fits best under the 'Legal Proceedings Report' (LTR) category if it relates to regulatory actions, or potentially 'Regulatory Filings' (RNS) as a general announcement. Since it specifically details a regulatory clearance/approval which is a significant event impacting operations and market access, and it is not a standard financial report (10-K, IR, ER), LTR is the most appropriate specific category for reporting on regulatory actions/clearances, although RNS is a close fallback. Given the context of FDA clearance, LTR (Legal/Regulatory Action) is chosen over the general RNS.
2015-10-27 English
Mauna Kea Technologies : feu vert de la FDA pour le cellvizio en chirurgie minimalement invasive
Regulatory Filings Classification · 100% confidence The document is a press release dated October 27, 2015, announcing that Mauna Kea Technologies has received 510(k) clearance from the FDA for its Cellvizio product for use in minimally invasive surgery. This type of announcement, detailing a significant regulatory milestone (FDA clearance) and its commercial implications, is typically classified as a general regulatory announcement or press release. Since it is not a full financial report (10-K, IR), an earnings release (ER), a management discussion (MDA), or a specific shareholder action (DIV, DVA), the most appropriate general category for a significant, non-financial regulatory update that doesn't fit elsewhere is Regulatory Filings (RNS). The document length (4319 chars) is short enough that it is not a comprehensive report itself, but rather an announcement of an event/clearance.
2015-10-27 French

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