Roche Diagnostics GmbH

罗氏诊断产品（上海）有限公司报告，由于发现%Quick值超出了产品规范（假性偏低），生产商罗氏诊断公司Roche Diagnostics GmbH对其生产的凝血酶原时间检测卡（电化学法）（国械注进20202400275）主动召回。召回级别为二级召回。本次召回涉及的产品未进口至中国，具体型号、规格及批次等详细信息见《医疗器械召回事件报告表》。 附件：医疗器械召回事件报告表2024年10月17日罗氏诊断产品（上海）有限公司召回报表.pdf

May 30, 2024Announcement no. 12 BioPorto A/S Appoints Chief Financial Officer BioPorto A/S (BioPorto) (CPH:BIOPOR) today announced the appointment of Niels Høy Nielsen as its new Executive Vice President (EVP) and Chief Financial Officer (CFO), and member of the Executive Management team as of August 1, 2024. Niels Høy Nielsen is a highly skilled leader with more than 20 years of experience in finance, operations, M&A and capital markets. He joins BioPorto from ChemoMetec A/S, a Danish NASDAQ listed healthcare company, where he served as CFO from 2022. Prior to this, Niels Høy Nielsen was the CFO of ConvaTec, Infusion Care, a global distributor of medtech products within wound and stoma care, and before that a 10-year tenure with LEO Pharma A/S, heading up departments in finance, commercial and manufacturing. Niels Høy Nielsen holds a Master of Science in Finance and Accounting from Aarhus School of Business supplemented with leadership education at IMD. Peter Mørch Eriksen, Group CEO of BioPorto says: “I am excited about welcoming Niels to the Executive Management team at BioPorto. Niels is joining us with a strong track record and extensive knowledge built on both life science industry insights and diligently managing finance, capital markets and investor relations for global companies. I look very much forward to having Niels on board to support execution towards our ambitious goals for growth and development of BioPorto”. With this hiring, BioPorto has now established its new leadership team with Peter Mørch Eriksen as Group CEO, Gry Husby Larsen as EVP & CLO, Niels Høy Nielsen as EVP & CFO and Jeffrey Haas as President & CEO of BioPorto’s subsidiary BioPorto Inc. To receive BioPorto’s Company Announcements, Press Releases, Newsletters and other business relevant information, please sign up on https://bioporto.com/investor-contact/. For inquiries, please contact Investor Relations Claus Thestrup, HC Andersen Capital, +45 4529 0000, investor@bioporto.com Ashley R. Robinson, LifeSci Advisors, +1 617 430 7577, arr@lifesciadvisors.com About Acute Kidney Injury Acute kidney injury is a sudden episode of kidney failure or kidney damage that happens within a few hours or a few days. AKI causes a build-up of waste products in blood and makes it difficult for kidneys to maintain the proper balance of bodily fluids. AKI can also affect other organs such as the brain, heart, and lungs and is common in patients who are in hospital intensive care units. For more information about AKI please visit: https://bioporto.com/aki/. About BioPorto BioPorto is an in vitro diagnostics company focused on saving lives and improving the quality of life with actionable biomarkers – tools designed to help clinicians make changes in patient management. The Company uses its expertise in antibodies and assay development, as well as its platform for assay development, to create a pipeline of novel and compelling products that focus on conditions where there is significant unmet medical need, and where the Company’s tests can help improve clinical and economic outcomes for patients, providers, and the healthcare ecosystem. The Company’s flagship products are based on the NGAL biomarker and designed to aid in the risk assessment and diagnosis of Acute Kidney Injury, a common clinical syndrome that can have severe consequences, including significant morbidity and mortality, if not identified and treated early. With the aid of NGAL levels, physicians can identify patients potentially at risk of AKI more rapidly than is possible with current standard of care measurements, enabling earlier intervention and more tailored patient management strategies. The Company markets NGAL tests under applicable registrations including CE mark in several countries worldwide. BioPorto has facilities in Copenhagen, Denmark and Boston, MA, USA. The shares of BioPorto A/S are listed on the Nasdaq Copenhagen stock exchange. For more information visit www.bioporto.com. Forward-looking Statements This announcement may contain certain forward-looking statements. Words such as “initiate”, “may”, “focus”, “design”, “guide”, “plan”, “estimate”, “expand”, “target”, “potentially”, “will”, “should” and similar expressions identify such forward-looking statements, and such forward looking statements include statements with respect to commercialization activities in the U.S. and elsewhere, our collaboration with Roche Diagnostics GmbH (Roche), our ability to obtain regulatory approval to expand indications to analyzers other than the cobas c 501 or to other age groups and/or clinical indications, the buildout of our commercialization team and our financial guidance. Forward-looking statements involve risks, uncertainties and other factors, which may cause actual results, performance and achievements to differ materially from those contained in the forward-looking statements. These include numerous assumptions, risks and uncertainties, many of which are beyond BioPorto’s control. These assumptions, risks and uncertainties are described from time to time in BioPorto’s public announcements, its Interim Reports, and in its 2023 Annual Report under Risk Factors. BioPorto undertakes no obligation to publicly update or revise forward-looking statements to reflect subsequent events or circumstances after the date of this presentation, except as required by applicable law. Attachment 2024 05 30 - Announcement no. 12

Correction: Updated Annual Report attached April 4, 2024 Announcement no. 05 BioPorto Announces Annual Results for 2023 COPENHAGEN, DENMARK and BOSTON, MA, USA, April 4, 2024, (GLOBE NEWSWIRE) -- BioPorto A/S (BioPorto or Company) (CPH:BIOPOR), an in vitro diagnostics company focused on empowering the early detection of Acute Kidney Injury (AKI), announced today financial results for the year ended December 31, 2023. Highlights 2023 Revenue and adjusted EBITDA in 2023 are in line with the preliminary results announced on February 22, 2024. Revenue amounted to DKK 31m (USD 4.5m), equivalent to a 7% increase over 2022, and the adjusted EBITDA loss amounted to DKK 56m (loss of USD 8.1m) As of December 31, 2023, the Company had cash and cash equivalents of DKK 66m (USD 9.8m). Outlook for 2024 As announced on February 22, 2024, the expected revenue in 2024 is DKK 40m (USD 6m) corresponding to a growth rate of 30%. Growth is expected to be driven by increased sales of NGAL products – primarily in the US following the FDA clearance, supplemented by growth in the rest of the world. Revenue is expected to be back-end loaded, as US clinical commercialization of ProNephro AKI (NGAL) will commence in the second half of 2024. For 2024, an adjusted EBITDA loss in the range DKK 75-90m (loss of USD 11-13m) is expected. The expected loss relates to higher marketing costs for ProNephro AKI (NGAL) in the US, and the cost of new clinical trials to support FDA clearance for ProNephro AKI (NGAL) in adults. Peter Mørch Eriksen, BioPorto’s Chief Executive Officer, comments: “Reflecting on 2023, the most important milestone for BioPorto was undoubtedly the FDA clearance received in December for ProNephro AKI (NGAL) for pediatric and young adult use. The NGAL test is designed to help doctors identify intensive care unit (ICU) patients at risk of developing acute kidney injury (AKI) earlier than current standard care, which allows for prompt intervention and saving lives. The FDA clearance is a major proof of concept and defining for the future of BioPorto.” Peter Mørch Eriksen continues: “The growth in 2023 revenues is the results of a 25% increase in sales of our NGAL products for research use only in the US and for general use in Europe, Canada, Israel, South Korea and other markets where the test is CE marked. Throughout the year, we maintained tight control over costs and adjusted the organization to the leanest possible structure whilst awaiting the outcome of the FDA application.” “In February 2024, we launched our updated strategy plan laying the foundation for our strategic objectives and a detailed action plan for the next 3-5 years. The central elements of our strategy are to secure commercial traction in the US for clinical NGAL testing of pediatric and young adult patients, increase the sales of NGAL for adult use in CE marked countries, and initiating and submitting US FDA application for clearance of NGAL for adult use. I am happy to report that we are progressing according to plan; we have taken the first important steps in the instrument expansion plan, we have finalized the draft protocol for the FDA application of ProNephro AKI for adults and we have strengthened our US organization ahead of the commercialization of ProNephro AKI for pediatric and young adult use which will be initiated in second half of 2024, ” Peter Mørch Eriksen concludes. Conference Call and Webcast The Company’s management team will host an online investor presentation on April 4, 2024, at 10:00 am CET via HC Andersen Capital. Investors interested in attending the webcast may register at: BioPorto - Helår 2023 og forventninger til 2024 - Inderes To receive BioPorto’s Company Announcements, Press Releases, Newsletters and other business relevant information, please sign up on https://bioporto.com/investor-contact/. For inquiries, please contact Investor Relations Claus Thestrup, HC Andersen Capital, +45 4529 0000, investor@bioporto.com Ashley Robinson, LifeSci Advisors, +1 617 430 7577, arr@lifesciadvisors.com About Acute Kidney Injury Acute kidney injury is a sudden episode of kidney failure or kidney damage that happens within a few hours or a few days. AKI causes a build-up of waste products in blood and makes it difficult for kidneys to maintain the proper balance of bodily fluids. AKI can also affect other organs such as the brain, heart, and lungs and is common in patients who are in hospital intensive care units. For more information about AKI please visit: https://bioporto.com/aki/. About BioPorto BioPorto is an in vitro diagnostics company focused on saving lives and improving the quality of life with actionable biomarkers – tools designed to help clinicians make changes in patient management. The Company uses its expertise in antibodies and assay development, as well as its platform for assay development, to create a pipeline of novel and compelling products that focus on conditions where there is significant unmet medical need, and where the Company’s tests can help improve clinical and economic outcomes for patients, providers, and the healthcare ecosystem. The Company’s flagship products are based on the NGAL biomarker and designed to aid in the risk assessment and diagnosis of Acute Kidney Injury, a common clinical syndrome that can have severe consequences, including significant morbidity and mortality, if not identified and treated early. With the aid of NGAL levels, physicians can identify patients potentially at risk of AKI more rapidly than is possible with current standard of care measurements, enabling earlier intervention and more tailored patient management strategies. The Company markets NGAL tests under applicable registrations including CE mark in several countries worldwide. BioPorto has facilities in Copenhagen, Denmark and Boston, MA, USA. The shares of BioPorto A/S are listed on the Nasdaq Copenhagen stock exchange. For more information visit www.bioporto.com. Forward-looking Statements This announcement contains certain forward-looking statements. Words such as “initiate”, “may”, “focus”, “design”, “guide”, “plan”, “estimate”, “expand”, “target”, “potentially”, “will”, “should” and similar expressions identify such forward-looking statements, and such forward looking statements include statements with respect to commercialization activities in the U.S. and elsewhere, our collaboration with Roche Diagnostics GmbH (Roche), our ability to obtain regulatory approval to expand indications to analyzers other than the cobas c 501 or to other age groups and/or clinical indications, the buildout of our commercialization team and our financial guidance. Forward-looking statements involve risks, uncertainties and other factors, which may cause actual results, performance and achievements to differ materially from those contained in the forward-looking statements. These include numerous assumptions, risks and uncertainties, many of which are beyond BioPorto’s control. These assumptions, risks and uncertainties are described from time to time in BioPorto’s public announcements, its Interim Reports, and in its 2023 Annual Report under Risk Factors. BioPorto undertakes no obligation to publicly update or revise forward-looking statements to reflect subsequent events or circumstances after the date of this presentation, except as required by applicable law. Attachments Remuneration Report 2023 - BioPorto 5299004SWFL5JAN4W830-2023-12-31-en Annual Report 2023