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Xvivo Perfusion — Investor Relations & Filings

Ticker · XVIVO ISIN · SE0004840718 LEI · 549300G2464FYLS14B41 ST Manufacturing
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Filings indexed 286 across all filing types
Latest filing 2022-03-23 Regulatory Filings
Country SE Sweden
Listing ST XVIVO

About Xvivo Perfusion

https://www.xvivogroup.com/

Xvivo Perfusion is a medical technology company specializing in ex-vivo organ preservation for transplantation. The company develops machine perfusion technologies, solutions, and services designed to extend the life of major organs, including lungs, livers, and kidneys. Its core technology, organ perfusion, is an alternative to static cold storage that continuously supplies an organ with an oxygenated solution while it is outside the body. This process helps support cellular function, prevent tissue damage, and allows clinicians to assess organ viability prior to transplant. The company's objective is to increase organ utilization, extend preservation times, and improve patient outcomes. Key products include the XPS™ for lung perfusion, Liver Assist™, Kidney Assist Transport™, and the PERFADEX® Plus solution for lung preservation.

Recent filings

Filing Released Lang Actions
XVIVO obtains its first certificate under EU Medical Device Regulation (MDR) for Kidney Assist Transport
Regulatory Filings Classification · 95% confidence The document is a short announcement (3861 characters) detailing a specific corporate event: XVIVO obtaining an EU MDR certification for a product. It includes a date (March 23, 2022), contact information, and a concluding statement indicating the information is made public pursuant to the EU Market Abuse Regulation, followed by links to attachments. This structure strongly suggests a formal regulatory disclosure that is not a full financial report (like 10-K or IR) or a transcript. Since it is a specific, non-financial regulatory update (product certification/approval), and it is short and points to an attachment, it fits best under the general 'Regulatory Filings' category (RNS) as a miscellaneous regulatory announcement, rather than a specific financial or governance filing type. It is not an Earnings Release (ER), Director's Dealing (DIRS), or Capital Update (CAP). Given the nature of the announcement (regulatory milestone/approval), RNS is the most appropriate fallback.
2022-03-23 English
Earnings Release 2021
Earnings Release Classification · 100% confidence The document is titled "Bokslutskommuniké 2021" and contains detailed financial highlights for Q4 2021 and the full year 2021, including revenue, EBITDA, EBIT, net result, cash flow, and key operational metrics. The structure, content (financial figures, management commentary, key events), and the explicit mention of reporting periods (Q4 2021, Perioden 2021) strongly indicate this is a comprehensive financial report covering a full fiscal year, which aligns with the definition of an Annual Report (10-K) or a comprehensive period report. Since the text is in Swedish and appears to be the official year-end communication, it functions as the company's Annual Report disclosure, even if it is not explicitly labeled '10-K' (which is an SEC filing designation). Given the depth of financial data covering the entire year, '10-K' is the most appropriate classification for a full-year financial report, although 'IR' (Interim Report) covers comprehensive reports too. However, '10-K' is reserved for the *Annual* Report. The presence of the full year's data makes it an Annual Report equivalent. If this were a US filer, it would be a 10-K. For non-US filers presenting full-year results, this is the Annual Report equivalent. Q4 2021
2022-01-27 Swedish
Earnings Release 2021
Earnings Release Classification · 99% confidence The document is titled "Report on Operations 2021" and contains detailed financial summaries for Q4 2021 and the full year 2021, including Net sales, EBITDA, EBIT, Net profit, Cash flow, and Key ratios tables comparing 2021 to 2020. It also includes a CEO comment summarizing the year and the quarter, and discusses significant events and strategic outlook. This structure is characteristic of a comprehensive annual financial report, which aligns with the definition of an Annual Report (10-K), although this specific document is labeled 'Report on Operations' and appears to be a Swedish company's annual report rather than a formal SEC 10-K filing. Given the options, the content is far too detailed for an Earnings Release (ER) or Interim Report (IR) and is clearly the full-year review. Since '10-K' is the standard code for the official yearly report covering full financial performance, it is the most appropriate classification among the choices provided for a comprehensive annual report. Q4 2021
2022-01-27 English
XVIVOs Kidney Assist Transport får 510(k)-godkännande av amerikanska FDA och blir XVIVOs första regulatoriskt godkända produkt för transplantation av abdominala organ i USA
Regulatory Filings Classification · 100% confidence The document is titled "PRESSMEDDELANDE" (Press Release) and announces a specific event: receiving 510(k) clearance from the US FDA for a product (Kidney Assist Transport). It includes quotes from management (CEO, MD), company contact information, and a concluding statement about the information being disclosed under EU Market Abuse Regulation. This format strongly indicates a formal, immediate public announcement of a significant event, rather than a comprehensive periodic report (like 10-K or IR) or a transcript. Since it is a general regulatory announcement that doesn't fit the specific categories like DIV, CAP, or MANG, the most appropriate general category for immediate, non-periodic regulatory news is Regulatory Filings (RNS). The document length is moderate (4791 chars), but its nature is purely an announcement of regulatory news.
2022-01-21 Swedish
XVIVO’s Kidney Assist Transport receives 510(k) clearance by US FDA, which is XVIVO’s first regulatory cleared product for abdominal transplantation in the US
Regulatory Filings Classification · 100% confidence The document announces a significant regulatory event: the US FDA granting 510(k) clearance for XVIVO's Kidney Assist Transport device. This is a specific, material event announcement, not a comprehensive periodic report (like 10-K or IR) or a standard earnings release (ER). It details a product approval and its market implications. Since it is a specific regulatory announcement that doesn't fit perfectly into the other categories (like DIRS, DIV, or M&A), and it is a formal press release format, the most appropriate general category for significant, non-standard regulatory news that isn't a core financial filing is 'Regulatory Filings' (RNS). The document length (4270 chars) suggests it is the full announcement, not just a notification of an attachment, ruling out RPA based on the 'MENU VS MEAL' rule for short notices.
2022-01-21 English
Major Shareholding Notification 2021
Major Shareholding Notification Classification · 99% confidence The document details a change in shareholding percentage for a specific holder (Swedbank Robur Fonder AB) in the issuer (Xvivo Perfusion Aktiebolag). It explicitly states the 'Reason for major shareholding notification Sell' and provides 'Before the transaction' and 'After the transaction' figures, including the resulting percentage (9.99%). This structure perfectly matches the definition of a Major Shareholding Notification, which is categorized as 'MRQ'. The document is not a full report, an earnings release, or a management discussion.
2021-12-27 English

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