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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 2022-04-12 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
Informations privilégiées / Autres communiqués
Regulatory Filings Classification · 100% confidence The document is a press release dated April 12, 2022, announcing that Mauna Kea Technologies received a new 510(k) clearance from the US FDA for its Cellvizio platform to be used with molecular markers in specific procedures. This is a significant regulatory milestone announcement, not the full regulatory filing itself (like a 10-K or AR). It details a specific regulatory achievement (FDA clearance) and its implications. This type of announcement, which is a formal communication about a regulatory event, fits best under the general 'Regulatory Filings' category (RNS) as it is an official, non-financial, non-meeting-related announcement, or potentially a specialized announcement if one existed. Since the core event is a regulatory clearance announcement, and it is not a standard financial report (10-K, IR, ER, MRQ), 'RNS' (Regulatory Filings - general regulatory announcements/fallback) is the most appropriate classification for a press release detailing a specific regulatory clearance.
2022-04-12 French
Inside Information / Other news releases
Regulatory Filings Classification · 100% confidence The document is a press release dated April 12, 2022, announcing a significant regulatory milestone: a U.S. FDA 510(k) clearance for Mauna Kea Technologies' Cellvizio platform. This type of announcement, detailing regulatory achievements, collaborations, and future potential, is characteristic of an Earnings Release (ER) or a general corporate update. Since it focuses on a specific, positive operational/regulatory event rather than comprehensive periodic financial results (like 10-K or IR) or management compensation (DEF 14A), it fits best as an Earnings Release (ER) which often includes key operational highlights, or potentially a Regulatory Filing (RNS) if it were a brief notification. Given the substantial detail about the FDA clearance, the clinical implications, and quotes from the CEO, it functions as a major corporate announcement, which often accompanies or substitutes for a formal earnings release when discussing key operational achievements. However, none of the definitions perfectly capture a 'Press Release announcing a Regulatory Clearance.' Reviewing the definitions: - ER (Earnings Release): Initial announcement of quarterly/periodical financial results (key highlights only). This is not primarily financial results, but a major operational/regulatory highlight. - RNS (Regulatory Filings): General regulatory announcements and fallback category. - LTR (Legal Proceedings Report): Not applicable. Since this is a press release detailing a major regulatory achievement (FDA clearance) and includes forward-looking statements and boilerplate information typical of corporate communications, it is most closely aligned with the function of an Earnings Release (ER) if it were a quarterly announcement, or it falls under the general category of important corporate news. In many databases, significant operational/regulatory news released outside of mandated quarterly filings are classified as ERs or RNS. Given the length and detail, it's more than a simple RNS notification. It functions as a key highlight announcement. I will classify it as an Earnings Release (ER) as these often contain the most significant operational/regulatory news of the period, even if financial tables are absent, or as RNS as a fallback for significant, non-standard announcements. Given the context of financial reporting databases, major operational milestones announced via press release are often grouped with ERs or RNS. I will select RNS as the most appropriate fallback for a specific regulatory press release that isn't a full financial report or a management change announcement, as it is a 'general regulatory announcement.'
2022-04-12 English
Informations privilégiées / Autres communiqués
Report Publication Announcement Classification · 99% confidence The document is a press release dated March 10, 2022, announcing that Mauna Kea Technologies will be presenting at the Oppenheimer Annual Healthcare Conference on March 17, 2022. This type of announcement, which informs the public about the company's participation in an external investor event (like a conference presentation), is best classified as an Investor Presentation (IP) announcement or, more broadly, a general regulatory filing if the specific IP category is for the presentation material itself. However, since the document is an announcement *about* participation in an investor conference, and it is short (under 5,000 characters) and serves to inform investors of future engagement, it aligns closely with materials related to investor relations activities. Given the options, this is not a formal report (10-K, IR), a transcript (CT), or a dividend notice (DIV). It is an announcement regarding investor engagement. While 'IP' is for the presentation itself, this is the announcement of the presentation. In many databases, such announcements are categorized under Investor Presentation (IP) or sometimes as a Regulatory Filing (RNS) if no better fit exists. Since the core subject is the company's participation in an investor conference where they will present, 'IP' (Investor Presentation) is the most contextually relevant category, even though it is the announcement rather than the presentation slides. Given the strict definitions, and that it is an announcement of future investor engagement, I will lean towards the most specific category related to investor communication events, which is IP, or RNS as a fallback. Since it is an announcement about an upcoming presentation, it is a form of investor communication. I will classify it as Investor Presentation (IP) as it directly relates to the event where an investor presentation will occur, although RPA could also be considered if it were announcing the *release* of a document. Given the context of conference participation, IP is the strongest fit among the specific categories.
2022-03-10 French
Inside Information / Other news releases
Investor Presentation Classification · 95% confidence The document is a press release announcing that Mauna Kea Technologies will be presenting at the 32nd Annual Oppenheimer Healthcare Conference on March 17, 2022. This is not the presentation material itself, nor is it a formal regulatory filing like a 10-K or an earnings release. It is an announcement about participation in an investor event. Among the provided codes, 'IP' (Investor Presentation) is related to investor events, but this document is an announcement *about* attending a conference, not the presentation slides themselves. Since it is an announcement regarding investor relations activities and participation in a conference, it most closely aligns with general investor communication. Given the options, and recognizing that it is an announcement about an upcoming investor event, it is best classified as a general Investor Relations communication. However, since there is no specific code for 'Conference Presentation Announcement', and it is not a formal regulatory filing (RNS) or a specific report, I must check if any code fits better. The document is short and announces participation in an investor conference. This type of announcement often falls under general Investor Relations updates. If we consider the context of investor engagement, 'IP' (Investor Presentation) is the closest thematic fit, although technically this is an announcement *of* a presentation. Given the available definitions, and the focus on an investor conference presentation, I will lean towards 'IP' as the most relevant category for investor-facing event participation announcements, although 'RNS' (Regulatory Filings/Miscellaneous) is a strong fallback. Since the content is entirely focused on an investor conference presentation, 'IP' is chosen over the generic 'RNS'.
2022-03-10 English
Inside Information / Other news releases
Regulatory Filings Classification · 95% confidence The document is a press release dated March 8, 2022, announcing a 'novel clinical research and product development collaboration' between two companies, On Target Laboratories and Mauna Kea Technologies. It details the scope of the collaboration (molecular image-guided procedures for pulmonary cancers) and includes quotes from management. This type of announcement, detailing strategic business development or partnership agreements, does not fit neatly into the specific financial reporting categories (like 10-K, ER, IR) or specific corporate action categories (like DIV, SHA, M&A). Since it is a general business announcement that doesn't fit the other specific codes (AGM-R, CT, DIRS, etc.), the most appropriate classification is the general regulatory/miscellaneous filing category, RNS (Regulatory Filings), which serves as a fallback for such announcements.
2022-03-08 English
Informations privilégiées / Autres communiqués
Regulatory Filings Classification · 95% confidence The document is a press release dated March 8, 2022, announcing a new clinical research and product development collaboration between two companies, On Target Laboratories and Mauna Kea Technologies, concerning molecular imaging guidance for lung cancer diagnosis. This type of announcement, detailing strategic partnerships, research progress, and business development, does not fit neatly into the specific financial reporting categories (like 10-K, ER, IR, DIV). It is a general corporate announcement regarding business operations and strategy. Since it is not a formal regulatory filing like a Director's Dealing (DIRS) or Major Shareholding (MRQ), and it is not a transcript (CT) or a presentation (IP), the most appropriate fallback category for a significant, non-standard corporate announcement is Regulatory Filings (RNS), which serves as a general category for miscellaneous regulatory/corporate news releases that don't fit elsewhere.
2022-03-08 French

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