DUBLIN and NEW YORK, March 18, 2026 (GLOBE NEWSWIRE) -- Trinity Biotech plc (Nasdaq: TRIB), a commercial-stage biotechnology company focused on human diagnostics and diabetes management solutions, including wearable biosensors, today announced it has entered into a collaboration agreement with the University at Buffalo, New York (“UB”). The partnership focuses on advancing and commercializing a suite of proprietary biomarkers for the earlier and more accurate detection of Sjögren’s Syndrome, one of the most ...

Mdxhealth Highlights Data from Oxford’s ProMPT Study Demonstrating the Genomic Prostate Score GPS Test Predicts Adverse Outcomes Across Multiple Treatment Settings at EAU 2026 IRVINE, California – March 16, 2026 (GlobeNewswire) – Mdxhealth SA (NASDAQ: MDXH) (the "Company" or "mdxhealth"), a leader in urology-focused precision diagnostics, today announced that new data demonstrating the prognostic value of the Genomic Prostate Score (GPS mdx) test across multiple treatment strategies were presented on March ...

Mdxhealth Highlights Data from Oxford’s ProMPT Study Demonstrating the Genomic Prostate Score GPS Test Predicts Adverse Outcomes Across Multiple Treatment Settings at EAU 2026 IRVINE, California – March 16, 2026 (GlobeNewswire) – Mdxhealth SA (NASDAQ: MDXH) (the "Company" or "mdxhealth"), a leader in urology-focused precision diagnostics, today announced that new data demonstrating the prognostic value of the Genomic Prostate Score (GPS mdx) test across multiple treatment strategies were presented on March ...

Core Insights - Plus Therapeutics, Inc. is focused on developing precision diagnostics and radiopharmaceuticals for CNS cancers, with significant financial results and business highlights reported for Q4 2025 and the full year [1] Corporate Highlights - The company completed an upsized public offering generating $15 million in gross proceeds, extending its cash runway to support CNSide commercialization and two ongoing Phase 2 clinical programs [2] - The company secured an American Medical Association Category III CPT reimbursement code for REYOBIQ, enhancing market access for its therapy in recurrent glioblastoma and pediatric brain cancer [7] - CNSide laboratory licensing has expanded to 49 of 50 U.S. states, allowing access to the CNSide Tumor Cell Enumeration test for approximately 95% of the U.S. population [7] - The company recognized $5.2 million in grant revenue for 2025, compared to $5.8 million in 2024, primarily from CPRIT for REYOBIQ development [7] Financial Results - The company's cash and investments balance was $13.1 million on December 31, 2025, up from $3.6 million on December 31, 2024 [7] - Total operating loss for 2025 was $15.3 million, compared to $14.7 million in 2024, attributed to the expansion of the CNSide operations team [7] - Net loss for 2025 was $22.4 million, or $(0.29) per basic share, compared to a net loss of $13.0 million, or $(1.95) per basic share, in 2024 [7] Development and Clinical Programs - REYOBIQ is being evaluated for recurrent glioblastoma, leptomeningeal metastases, and pediatric brain cancer in ongoing clinical trials [12] - The company anticipates increased R&D expenditures in 2026 due to costs associated with the ReSPECT-LM clinical trial and manufacturing scale-up for REYOBIQ [9] - The company aims for CNSide Diagnostics to breakeven by 2027, with expected increases in general and administrative expenditures in 2026 [10] Future Milestones - The company plans to define the optimal dose for REYOBIQ in the ReSPECT-LM Phase 2 trial, with data expected in Q3 2026 [15] - Enrollment in the ReSPECT-GBM Phase 2 trial is expected to be completed, with data anticipated in Q4 2026 [15] - The company aims to expand U.S. commercial payer coverage to over 150 million covered lives and achieve more than 1,250 annualized test orders [16]

Financial Data and Key Metrics Changes - The reported revenue for Q4 2025 was $29.5 million, a 19% increase from $24.7 million in Q4 2024 [10] - Gross profit for Q4 2025 was $18.7 million, up 20% from $15.5 million in Q4 2024, with gross margins increasing to 63.2% from 62.7% [11] - The operating loss for Q4 2025 increased by 14% to $5.3 million compared to $4.6 million in Q4 2024 [11] - Net loss rose 31% to $8.9 million from $6.8 million in the prior year, driven by increased financial expenses [12] - Adjusted EBITDA for Q4 was -$2.1 million, compared to -$1.4 million in Q4 2024 [12] - Cash and cash equivalents as of December 31, 2025, were $29 million [12] Business Line Data and Key Metrics Changes - Total billable volume in Q4 was approximately 38,000 tests, with tissue-based tests decreasing by 5% and liquid-based tests increasing by 128% year-over-year [10] - The acquisition of ExoDx contributed to the growth in liquid-based tests, which include Select mdx, Resolve mdx, and ExoDx [10][34] Market Data and Key Metrics Changes - The company aims to balance revenue contributions from tissue and liquid tests, which previously saw tissue tests accounting for 85% of revenue [34] - The integration of ExoDx is expected to enhance the customer base and drive growth in both segments [34] Company Strategy and Development Direction - MDxHealth's strategy focuses on menu expansion, operational discipline, and customer experience, which are expected to drive sustained top-line growth [4][6] - The company is committed to integrating ExoDx and enhancing its sales organization to capitalize on the combined customer base [34] - The goal for 2026 is to achieve revenue guidance of $137 million to $140 million, reflecting a 28% year-over-year growth [34] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to deliver growth and profitability, emphasizing the importance of operational discipline and customer experience [3][14] - The integration of ExoDx is seen as a significant growth opportunity, with expectations for improved operational efficiencies and market leadership in prostate cancer diagnostics [6][16] Other Important Information - The company amended its earn-out payment to Exact Sciences, reducing the upcoming payment by nearly $20 million, providing additional financial flexibility [8] - The collaboration with the University of Oxford is expected to enhance the utility of the GPS test in clinical guidelines, further solidifying MDxHealth's market position [16] Q&A Session Summary Question: Tissue ASP decline and mix shift - Management confirmed that the decline in tissue ASP was due to a mix shift towards Confirm and noted that ASPs reflect Medicare rates [19] Question: EBITDA performance and cash flow - Management acknowledged the lower EBITDA and higher cash burn, attributing it to the integration of ExoDx and expressed confidence in achieving a 10% EBITDA margin by year-end [20][21] Question: 2026 revenue guidance assumptions - Management indicated that the guidance reflects balanced growth from both tissue and liquid segments, with significant contributions expected from the ExoDx acquisition [32][34] Question: Operating leverage and gross margin expectations - Management stated that they expect to maintain flat OpEx while achieving growth and indicated that gross margins are expected to remain in the low 60s, with aspirations for improvement [44][46]

Core Insights - Photocure ASA reported Hexvix®/Cysview® revenues of NOK 135.1 million in Q4 2025, an increase from NOK 128.6 million in Q4 2024, indicating a positive revenue trend [1] - The company achieved a commercial EBITDA of NOK 8.4 million in Q4 2025, up from NOK 3.9 million in Q4 2024, reflecting improved operational efficiency [1] - For 2026, Photocure anticipates product revenue growth between 7% to 11% on a constant currency basis, supported by ongoing operational leverage [1] Financial Performance - Total revenues for Q4 2025 were NOK 136.7 million, down from NOK 141.7 million in Q4 2024, which included a milestone payment [1] - Group EBITDA for Q4 2025 was NOK 1.9 million, compared to NOK 8.5 million in Q4 2024, while EBIT was reported at NOK -5.5 million, down from NOK 1.2 million [1] - Cash and cash equivalents stood at NOK 238.9 million at the end of Q4 2025 [1] Strategic Initiatives - The company installed 7 new Saphira towers in the U.S. during Q4 2025, contributing to a 22% increase in active accounts, totaling 384 [1] - Photocure is expanding its blue light cystoscopy (BLC®) use and has installed 60 Olympus Visera Elite III systems in Europe since Q1 2025 [1] - The partnership with Claritas and other strategic initiatives aim to enhance the company's diagnostic capabilities and expand its market opportunities [1] Growth Drivers - Continued adoption of rigid kits, expansion of mobile BLC, and ongoing equipment upgrades are expected to drive growth in the base business [1] - Potential catalysts for growth include developments in CMS reimbursement, reintroduction of flexible BLC solutions, and a possible FDA reclassification of BLC [1] - The licensing agreement with Asieris for Cevira includes a significant milestone payment upon regulatory approval in China, along with future royalties based on sales [1]

Core Insights - Tian Ruixiang Holdings Limited is expanding its AI-powered healthcare ecosystem, solidifying its leadership in the Asia-Pacific region [1][5] - The company is entering strategic partnerships and acquisition discussions with Singapore's top three medical technology leaders to enhance insurance-clinic integration and precision diagnostics [1][2] Strategic Partnership and Acquisitions - The proposed collaborations and acquisitions are expected to be finalized within the next 12 months, integrating Singapore's AI diagnostic expertise into TIRX's pan-Asia network [2][5] - This integration aims to create a fully integrated AI healthcare platform, enhancing precision, accessibility, and efficiency for patients, providers, and insurers [2][5] Transformative Pillars - **AI Diagnostic Supremacy**: The partnership will leverage Singaporean medical tech leaders' AI platforms to achieve over 95% accuracy in predictive diagnostics within TIRX's insurance clinic networks, improving early disease detection and treatment outcomes [3][4] - **Pan-Asia Integration**: Establishing a seamless network of insurance clinics across the Asia-Pacific, enabling real-time patient data integration and personalized treatment pathways [4] - **Operational Excellence**: Automating 70% of routine healthcare workflows, reducing operational costs by over 40%, and unlocking significant value across the healthcare value chain [4] Market Position and Growth Potential - The completion of the acquisitions and partnerships is subject to regulatory approvals and shareholder consent, with TIRX aiming to finalize these within the next 12 months [5] - This strategic move positions TIRX as a dominant player in the Asia-Pacific AI healthcare market, potentially catalyzing exponential growth in AI-related revenue [5][6]

Core Insights - MDxHealth reported preliminary revenues for Q4 and full year 2025, with Q4 revenues of approximately $30.5 million and full year revenues of $109 million, reflecting year-over-year growth of 23% and 21% respectively [2][5] - The company issued revenue guidance for 2026, projecting revenues between $137 million and $140 million, indicating a year-over-year growth of 26-28% [3][5] - MDxHealth amended earnout terms with Exact Sciences, deferring payments related to the GPS acquisition, with payments scheduled for 2026, 2027, and 2028 totaling $54.5 million [4] Financial Performance - For Q4 2025, MDxHealth billed 11,201 tissue-based units and 27,486 liquid-based units, showing year-over-year growth of (5%) and 128% respectively [2] - For the full year 2025, the company billed 49,180 tissue-based units and 71,920 liquid-based units, representing year-over-year growth of 18% and 57% respectively [2] - The cash balance at year-end 2025 was reported at $29.0 million [2] Strategic Outlook - The CEO expressed confidence in the company's growth strategy, emphasizing the strength of the sales channel and expanded offerings to the urology customer base [5] - The company anticipates achieving an adjusted EBITDA margin run rate of 10% by the end of 2026 [5]

Core Insights - The ZIRCON-X study indicates that nearly half of patients imaged with TLX250-CDx would experience a change in clinical management compared to standard imaging methods [1][2] - The study highlights the potential of TLX250-CDx to improve clinical decision-making in the management of indeterminate renal masses [5][6] Study Overview - ZIRCON-X was a non-interventional, prospective, post-hoc study involving 294 patients with indeterminate renal masses, assessing the impact of TLX250-CDx imaging versus standard contrast-enhanced imaging [2][6] - The study found that 143 patients (48.6%) would have had a change in clinical management, with over 20% potentially avoiding invasive biopsy [2][3] Clinical Management Changes - Among evaluable patients, 37.4% (110 out of 294) experienced major changes in clinical management, with approximately 30% having their treatment escalated or de-escalated [3] - The most common major changes included: - Biopsy to surgery (24 patients) - Surgery to biopsy (19 patients) - Additional diagnostic to surgery (18 patients) [4] Expert Commentary - Professor Karolien Goffin emphasized the significant potential of TLX250-CDx PET/CT to impact clinical decision-making for patients with small indeterminate renal masses [5] - Dr. David N. Cade noted that the analysis demonstrates the clinical usefulness of TLX250-CDx, which has been included in international guidelines for renal imaging [5] Product Information - TLX250-CDx is an investigational PET agent targeting carbonic anhydrase IX, expressed in over 95% of clear cell renal cell carcinoma (ccRCC) cells, providing high tumor-to-background imaging [8] - The pivotal Phase 3 ZIRCON trial showed TLX250-CDx achieved 86% sensitivity and 87% specificity for ccRCC [8]

Core Viewpoint - MDxHealth reported strong financial results for Q3 2025, with an 18% increase in revenues and a positive adjusted EBITDA of $1 million, alongside the strategic acquisition of Exosome Diagnostics from Bio-Techne Corporation [1][2][3]. Financial Performance - Q3 revenues reached $27.4 million, an 18% increase from $23.3 million in the same period last year [5][6]. - Year-to-date revenue growth was 20%, totaling $78.3 million compared to $65.3 million in the prior year [10][11]. - Gross profit for Q3 increased by 25% to $17.9 million, with gross margins improving to 65.2% from 61.2% [8][9]. - Operating expenses remained flat at $20.5 million, despite $1.5 million in acquisition-related expenses [9][11]. - The net loss for Q3 decreased by 28% to $8.0 million, compared to $11.2 million in the prior year [9][12]. Strategic Developments - The acquisition of Exosome Diagnostics was completed on September 15, 2025, which is expected to enhance the company's product offerings and sales capabilities [3][4]. - The company plans to focus on integrating the ExoDx business and has expanded its direct sales team from 50 to 60 representatives to leverage cross-selling opportunities [3][4]. - The introduction of germline products has been suspended to allocate resources towards ExoDx, Confirm, and GPS, with a reevaluation planned for 2026 [3][4]. Future Outlook - MDxHealth reaffirmed its full-year revenue guidance of $108 million to $110 million, expecting Q4 growth to meet or exceed 20% [4][12]. - The company reported a positive adjusted EBITDA of $1 million for Q3, marking a significant improvement from a loss of $3.9 million in the prior year [10][12].