In Vitro Diagnostics
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BioPorto A/S to host an investor webcast on the results for the first half of 2025
Globenewswire· 2025-07-29 13:28
Core Viewpoint - BioPorto A/S will present its financial results for the first half of 2025 during an investor webcast scheduled for August 15, 2025 [1] Company Overview - BioPorto A/S is an in vitro diagnostics company focused on improving patient management through actionable biomarkers [2] - The company specializes in antibody and assay development, aiming to address significant unmet medical needs with its product pipeline [2] Key Products - The flagship products of BioPorto are based on the NGAL biomarker, which aids in the risk assessment and diagnosis of Acute Kidney Injury (AKI) [3] - NGAL tests allow for quicker identification of patients at risk of AKI compared to standard care measurements, facilitating earlier intervention [3] Market Presence - BioPorto has facilities located in Copenhagen, Denmark, and Boston, MA, USA, and its shares are listed on the Nasdaq Copenhagen stock exchange [4]
QuidelOrtho to Report Second Quarter 2025 Financial Results
Prnewswire· 2025-07-22 20:30
Core Viewpoint - QuidelOrtho Corporation will report its financial results for the second quarter of 2025 on August 5, 2025, after market close [1] Financial Results Announcement - The financial results will be discussed in a conference call scheduled for 2:00 p.m. PT / 5:00 p.m. ET on the same day [2] - Interested parties can access the call via the Company's Investor Relations page or by phone using specific dial-in numbers [2] Replay Availability - A replay of the conference call will be available shortly after the event on the Company's Investor Relations page [3] Company Overview - QuidelOrtho Corporation is a leader in in vitro diagnostics, focusing on innovative solutions that enhance understanding and action in healthcare [4] - The company specializes in immunoassay and molecular testing, clinical chemistry, and transfusion medicine, providing reliable diagnostics across various settings [4][5]
MVP Health Care and Renalytix Partner to Bring Life-Changing Kidney Disease Testing to Local Communities
Prnewswire· 2025-07-21 11:00
Core Insights - Renalytix Plc and MVP Health Care have formed a partnership to enhance access to kidney care for individuals with type 2 diabetes and chronic kidney disease, aiming to improve health outcomes and reduce health disparities [1][2] - The collaboration will implement the kidneyintelX.dkd™ FDA-approved test across MVP's network, facilitating earlier interventions and personalized care plans for patients [2][3] - The kidneyintelX.dkd™ test will be available to all MVP customers in New York, including those with Medicare or Medicaid, and is endorsed by KDIGO, the international clinical guideline organization for kidney disease [3] Company Overview - Renalytix is an AI-enabled in vitro diagnostics company focused on improving clinical management of kidney disease, with FDA approval and Medicare reimbursement for the kidneyintelX.dkd test [5] - MVP Health Care is a not-for-profit health insurer serving New York and Vermont, dedicated to enhancing the well-being of its members and communities [6] Impact on Patient Care - The partnership aims to identify patients at higher risk for kidney function decline earlier, allowing for targeted resources and therapeutic options, which can lead to better management of cardiovascular and metabolic conditions [1][4] - The use of kidneyintelX.dkd has shown measurable improvements in patient outcomes and quality metrics, particularly in managing blood pressure and HbA1c levels in high-risk populations [4]
Real Labs, Actual Decisions With Actionable Six Sigma Metrics
Prnewswire· 2025-07-17 11:00
Group 1 - QuidelOrtho Corporation is a leader in in vitro diagnostics, focusing on transforming data into actionable insights for healthcare [4][5]. - The company specializes in immunoassay and molecular testing, clinical chemistry, and transfusion medicine, providing reliable diagnostics across various settings [4]. - QuidelOrtho emphasizes innovation and collaboration with global healthcare customers to enhance diagnostic solutions [5]. Group 2 - A session titled "Real Labs, Real Decisions with Actionable Six Sigma Metrics" is scheduled for July 29, 2025, at the McCormick Convention Center in Chicago [1]. - The session will feature a panel of experts, including Dr. Jared Jaeger from QuidelOrtho and other professionals from notable institutions [2]. - Attendees can register for the session or access a recording if unable to attend [3].
Initiation of commercialization of ProNephro AKI (NGAL) for diagnostic use in the US
Globenewswire· 2025-06-27 07:20
Core Points - BioPorto A/S has initiated the commercialization of ProNephro AKI (NGAL) for diagnostic use in the US, marking a significant milestone in the company's kidney diagnostics platform [1][3] - The first purchase order for ProNephro AKI (NGAL) has been received from Roche Diagnostics, which will facilitate distribution to US hospitals [2][3] - ProNephro AKI (NGAL) has received FDA 510(k) marketing clearance for use with Roche's cobas® c501 analyzers, which are widely available in medical laboratories and hospitals [2] Company Overview - BioPorto is an in vitro diagnostics company focused on developing actionable biomarkers to improve patient management and outcomes [4] - The company's flagship products utilize the NGAL biomarker to aid in the risk assessment and diagnosis of Acute Kidney Injury (AKI), a condition that can lead to severe health consequences if not identified early [5] - BioPorto operates facilities in Copenhagen, Denmark, and Boston, MA, USA, and is listed on the Nasdaq Copenhagen stock exchange [6]
BioPorto A/S Announces the Appointment of a New CEO as Part of its Succession Planning Strategy
Globenewswire· 2025-06-10 14:20
Core Viewpoint - BioPorto A/S has announced the appointment of Carsten Buhl as the new CEO, effective September 1, 2025, as part of its succession planning strategy [1][2]. Company Leadership Transition - Current CEO Peter Mørch Eriksen will remain in his position until September 1, 2025, and will assist Carsten Buhl during the transition period [2]. - Carsten Buhl has over 25 years of experience in the MedTech/life science industries, previously serving as President of Americas at WSAudiology and holding senior leadership roles at Natus Medical Inc, Ambu, and GN Store Nord [3]. Strategic Goals and Future Plans - Jens Due Olsen, Chair of BioPorto, emphasized that Carsten Buhl will play a crucial role in launching ProNephro AKI (NGAL)™ in the US market, driving revenue growth, and finalizing clinical studies for an FDA application for adult use in 2026 [4]. - Carsten Buhl expressed enthusiasm about joining BioPorto and aims to unlock the full potential of the company's biomarker tests for kidney health, which can enhance clinical and economic outcomes globally [4]. Company Achievements - Under Peter Mørch Eriksen's leadership, BioPorto achieved significant milestones, including the development of a comprehensive Corporate Strategy Plan, revenue growth, preparation for the commercial launch of ProNephro AKI (NGAL) in the US, and securing critical financing rounds [4]. Company Overview - BioPorto specializes in in vitro diagnostics, focusing on actionable biomarkers to improve patient management and outcomes [5]. - The company's flagship products utilize the NGAL biomarker to aid in the risk assessment and diagnosis of Acute Kidney Injury (AKI), enabling earlier intervention and tailored patient management strategies [6].
GXO extends longstanding partnership with bioMérieux
GlobeNewswire News Room· 2025-05-22 11:00
Core Insights - GXO Logistics, Inc. has announced a long-term contract renewal and extension with bioMérieux, marking over 20 years of partnership in logistics services [1][2] Group 1: Contract and Collaboration - The renewed contract includes the extension of services for the Instrumentation range, following a successful overhaul of the Reagents range distribution [2] - GXO has utilized its logistics expertise to optimize bioMérieux's supply chain since 2004, focusing on innovation to enhance operational efficiency [2][4] Group 2: Logistics Solutions - The collaboration has led to a redesign of warehouse layouts to accommodate new flows while maintaining service quality, integrating automation to boost productivity and manage six temperature ranges of reagents [2][3] - GXO's operation features a unified Warehouse Management System, handling inbound and outbound logistics, while bioMérieux focuses on high-value processes like short-term storage and direct customer shipments [3] Group 3: GXO's Operations in France - GXO operates over 65 warehouses in France and is ranked as the 2 logistics service provider in the country, employing nearly 10,000 team members [5] - The company manages logistics across various sectors, including ecommerce, retail, FMCG, and technology, ensuring visibility of inventory and orders while managing sensitive, high-value SKUs [4][5] Group 4: Company Overview - GXO Logistics is the world's largest pure-play contract logistics provider, benefiting from the growth of ecommerce and automation, with over 150,000 team members across more than 1,000 facilities [6] - The company partners with leading blue-chip companies to address complex logistics challenges using advanced supply chain solutions [6]
SRDX Stock Down Following Q2 Earnings Miss, Gross Margin Contracts
ZACKS· 2025-05-01 17:50
Core Viewpoint - Surmodics, Inc. reported a wider-than-expected adjusted loss per share and lower-than-expected revenues for the second quarter of fiscal 2025, indicating challenges in its Medical Device segment and overall financial performance [1][14]. Revenue Performance - Surmodics generated revenues of $28.1 million in the fiscal second quarter, a decrease of 12.1% year over year, missing the Zacks Consensus Estimate by 8.7% [2]. - Total revenues included $0.3 million from SurVeil drug-coated balloon (DCB) license fees, down from $1.1 million in the same quarter of the previous year, attributed to lower expenses related to the TRANSCEND clinical trial [3]. - Product sales were $14.9 million, down 17.2% from the prior-year quarter, and royalties and license fees totaled $9.9 million, down 13.2% [7]. Segment Analysis - The Medical Device segment reported sales of $20.7 million, a decline of 16.6% year over year, with revenues excluding SurVeil DCB license fees decreasing 14% [5]. - In Vitro Diagnostics (IVD) sales improved by 3.4% year over year to $7.4 million, driven by favorable order timing, although this was offset by a decline in microarray slide/surface revenues [6]. Margin and Expenses - Gross profit decreased by 18.5% year over year to $20.3 million, with gross margin contracting 566 basis points to 72.1% [9]. - Selling, general & administrative expenses increased by 14.9% year over year to $15 million, while research and development expenses declined by 18.2% to $8.4 million [9]. Financial Position - Surmodics ended the second quarter with cash and cash equivalents of $29.2 million, a slight decrease from $30.1 million at the end of the previous quarter [11]. - Total long-term debt was $29.63 million, marginally up from $29.59 million in the prior quarter [11]. Fiscal Guidance - The company expects total revenues for fiscal 2025 to be in the range of $114 million to $117 million, reflecting a decrease of 10-7% compared to fiscal 2024 [12]. - Surmodics anticipates a decrease of $3.6 million in SurVeil DCB license fee revenues and a $7 million decrease in SurVeil DCB product revenues for fiscal 2025 [13]. Market Reaction - Shares of Surmodics fell nearly 9.4% at the end of the trading session following the earnings report [4].
Grant of Warrants
Globenewswire· 2025-04-28 16:28
Core Viewpoint - BioPorto A/S has issued 1,700,000 warrants to its Board of Directors as part of their remuneration, with each warrant allowing the purchase of one share at an exercise price of DKK 1.50, reflecting the current closing price on Nasdaq Copenhagen [1][2]. Summary by Sections Warrants Issuance - The issuance of warrants was approved during the annual general meeting on April 11, 2025, and is part of the company's compensation strategy for its Board members [1]. - The warrants will vest in equal tranches quarterly over a two-year period, with the first tranche becoming available at the start of the first calendar quarter following the grant date [3]. Terms and Conditions - The warrants are governed by the company's incentive warrant program and include provisions for claw-back in cases of erroneous financial information and accelerated vesting in the event of a takeover or business combination [4]. - The theoretical market value of the newly issued warrants is calculated to be DKK 1,843,580, based on the Black-Scholes formula, with an interest rate of 2.37% and historical volatility of 63.82% over 120 months [5]. Company Overview - BioPorto specializes in in vitro diagnostics, focusing on actionable biomarkers to enhance patient management and improve clinical outcomes [7]. - The company's flagship products utilize the NGAL biomarker to assist in the risk assessment and diagnosis of Acute Kidney Injury (AKI), enabling faster identification and intervention for at-risk patients [8]. - BioPorto operates facilities in Copenhagen, Denmark, and Boston, MA, USA, and is listed on the Nasdaq Copenhagen stock exchange [9].
BioPorto A/S to host first quarter 2025 earnings webcast for investors
Globenewswire· 2025-04-28 14:41
Core Viewpoint - BioPorto A/S is set to present its financial results for Q1 2025 during a webcast on May 8, 2025, highlighting its focus on early detection of Acute Kidney Injury (AKI) [1] Company Overview - BioPorto A/S specializes in in vitro diagnostics aimed at improving early detection of AKI, utilizing actionable biomarkers to enhance patient management [2][3] - The company leverages its expertise in antibodies and assay development to create innovative products addressing significant unmet medical needs [2] Product Information - The flagship products of BioPorto are based on the NGAL biomarker, which aids in the risk assessment and diagnosis of AKI, a condition that can lead to severe health consequences if not treated promptly [3] - NGAL tests allow for quicker identification of patients at risk of AKI compared to standard care measurements, facilitating earlier interventions and tailored management strategies [3] Company Facilities and Stock Information - BioPorto operates facilities in Copenhagen, Denmark, and Boston, MA, USA, and is listed on the Nasdaq Copenhagen stock exchange [4]