Company Overview - Biodesix is a leading diagnostics company focused on improving clinical care and patient outcomes[1, 12] - The company's mission is to transform patient care through personalized diagnostics that are timely, accessible, and address immediate clinical needs[13] - Biodesix envisions a world where patient diseases are conquered with the guidance of personalized diagnostics[14] Business Lines and Key Capabilities - Biodesix generates revenue through two business lines: Lung Diagnostic Tests and Development Services[15] - The company expects to have approximately 95 sales representatives focused on lung diagnostics in the field by 4Q25[19] - Biodesix boasts industry-leading gross margins of 794%[19] - Development Services had $109 million in contracts not yet recognized as of the end of Q1 2025[73] Lung Diagnostic Tests - Lung cancer accounts for approximately 1 in 5 cancer deaths annually in the USA[29] - Approximately 80% of patients assessed for lung cancer risk fall into the low to moderate risk category (5-65%)[37, 43] - The Nodify Lung test identifies likely malignant nodules with 78% PPV, 98% specificity, and 28% sensitivity, and identifies likely benign nodules with 98% NPV, 97% sensitivity, and 44% specificity[46] Financial Performance - Total revenue for Q1 2025 was $180 million, representing a 21% year-over-year growth[76, 78] - Lung Diagnostics revenue in Q1 2025 was $163 million, an 18% increase year-over-year[76, 81] - Development Services revenue in Q1 2025 was $17 million, a 61% increase year-over-year[76, 81]

Key Takeaways Hologic's Molecular Diagnostics grew 7.8% in Q2 despite pressure from lost HIV testing revenues. Excluding USAID cuts, molecular sales would have seen low double-digit growth, per HOLX management. HOLX's molecular growth is fueled by innovation, including high-throughput vaginitis assays.Hologic’s (HOLX) Molecular Diagnostics business posted a 7.8% (excluding COVID-19-related sales) growth in the second quarter of fiscal 2025, although results did not reflect its full potential.The performan ...

Core Viewpoint - Biomerica, Inc. has received a Current Procedural Terminology (CPT) code for its inFoods IBS test, which will facilitate insurance reimbursement and expand patient access starting October 1, 2025 [1][2][10]. Group 1: Commercialization and Patient Access - The issuance of the PLA code is a significant milestone in Biomerica's strategy to commercialize the inFoods IBS test, enhancing transparency in claims submission and adjudication [3][4]. - The PLA code will streamline the claims process, supporting the goal of increasing adoption of the inFoods technology among patients and physicians [4][9]. - The inFoods IBS test is designed to identify food triggers for IBS symptoms, providing a personalized dietary therapy alternative to traditional medications [5][13]. Group 2: Market Need and Financial Implications - IBS affects approximately 10% to 15% of adults in the U.S., leading to up to $10 billion in direct annual medical costs, highlighting a substantial unmet need in the market [6]. - The inFoods IBS test offers a scientifically validated, non-invasive solution aimed at improving symptom control and quality of life for patients [6][9]. Group 3: Clinical Validation and Effectiveness - Results from a randomized, controlled clinical trial published in June 2025 demonstrated that patients following a diet based on inFoods test results experienced significantly greater symptom reduction compared to those on a placebo diet [7][14]. - The study showed that 59.6% of patients in the treatment group achieved the FDA's endpoint for abdominal pain reduction, compared to 42.2% in the control group [17]. Group 4: Long-Term Value Creation - The PLA code issuance enhances reimbursement transparency for the inFoods IBS test, aligning with the company's mission to provide personalized, non-drug solutions for chronic conditions [9][11]. - As insurance coverage expands and clinical evidence accumulates, the inFoods IBS test is positioned to become a key tool in managing IBS and related gastrointestinal disorders [9].

Core Points - Eurobio Scientific has completed the acquisition of the Life Science unit of Voden Medical Instruments Spa in Italy, enhancing its presence in the Italian market [2][3] - The acquisition focuses on diagnostics, cellular and molecular biology, and genome analysis, and will integrate the distribution of Eurobio's proprietary products in Italy [2][3] - The transaction is financed through a combination of the Group's cash and a bank loan, with the amount remaining confidential at the seller's request [2][6] Company Overview - Eurobio Scientific is a leading player in specialty in vitro diagnostics, involved in research, manufacturing, and commercialization of diagnostic tests across various fields including transplantation, immunology, and infectious diseases [4] - The company has a strong distribution network and a portfolio of proprietary products in molecular biology, supported by approximately 290 employees and multiple production units in various countries [4] - Eurobio Scientific is publicly listed on the Euronext Growth market in Paris and is part of several indices and investment programs [6]

Core Insights - Trinity Biotech has reached a critical profitability inflection point and expects to be Adjusted EBITDA positive and cash flow positive starting Q3 2025 [1][5][10] - The company has undergone significant operational restructuring to reduce costs and improve efficiency, laying the groundwork for sustainable profitability [5][10] - Trinity Biotech is focusing on growth opportunities, including the international rollout of new products and the development of innovative diagnostic solutions [5][12] Financial Performance - For Q1 2025, Trinity Biotech reported revenue of $7.6 million, with a gross profit of $1.9 million and an operating loss of $6.5 million [10] - The company anticipates a significant increase in revenue for Q2 2025, projecting a range of approximately $11 million to $12 million due to ramped-up manufacturing and normalized demand for rapid HIV tests [10] - The company expects further revenue growth in Q3 2025, driven by the resumption of manufacturing and supply of its flagship rapid HIV test, TrinScreen HIV [10] Strategic Developments - The company is advancing its next-generation continuous glucose monitoring (CGM) solution, which is seen as a major growth opportunity in the $13 billion global CGM market [5] - Trinity Biotech is also progressing towards commercialization of key medium-term growth drivers, including a preeclampsia screening test and a prostate cancer test [5] - The company has completed a pre-pivotal trial on its upgraded sensor technology for the CGM solution and plans to unveil key aspects of this innovative design soon [5]

Core Viewpoint - The healthcare sector is positioned as a strong long-term investment opportunity, with a focus on companies that have shown adaptability and are well-prepared for future challenges [2]. Group 1: Abbott Laboratories - Abbott Laboratories, founded in 1888, has a market capitalization of $240 billion and offers diverse healthcare products across multiple sectors [4]. - The company is a leader in medical devices, diagnostics, nutritional products, and established pharmaceuticals, with notable products like the MitraClip and FreeStyle Libre [5][6]. - Abbott anticipates an 8% year-over-year revenue growth in 2025 and continues to innovate, recently receiving the European CE Mark for the Volt PFA System [7][8]. - Abbott has a strong dividend history, having increased its dividend for 53 consecutive years [8]. Group 2: AbbVie - AbbVie, spun off from Abbott in 2013, has a market capitalization of approximately $328 billion and generated $56.3 billion in sales last year [9][10]. - The company has successfully navigated the loss of U.S. exclusivity for its top product, Humira, by investing in R&D and acquisitions, leading to a robust product pipeline [11]. - AbbVie’s successors to Humira, Rinvoq and Skyrizi, are projected to generate combined sales of $31 billion by 2027, surpassing Humira's peak sales [12]. - AbbVie has increased its dividend by a cumulative 310% since its spin-off, with a forward dividend yield of 3.51% [12]. - The stock is considered relatively inexpensive, trading at 15.2 times forward earnings, with growth potential from new products [13].

Core Viewpoint - Danaher Corporation is enhancing its digital transformation by appointing Martin Stumpe as Chief Technology and AI Officer, effective October 1, 2025, to lead the integration of AI across its global businesses [1][2][3]. Group 1: Appointment and Leadership - Martin Stumpe will report directly to Rainer Blair, President and CEO, marking a significant step in Danaher's ambition to lead innovation in life sciences and diagnostics [1][2]. - Stumpe's previous experience includes serving as Chief Data and AI Officer at Tempus and founding the Cancer Pathology project at Google, showcasing his expertise in AI and healthcare [3]. Group 2: Strategic Goals - Under Stumpe's leadership, Danaher aims to accelerate the integration of AI, enhancing scientific discovery, operational efficiency, and clinical impact [2][3]. - The company is committed to leveraging science, data, and technology to improve human health, emphasizing the importance of innovation in addressing health challenges globally [3][4]. Group 3: Company Overview - Danaher is recognized as a leading global innovator in life sciences and diagnostics, with a workforce of 63,000 associates dedicated to improving quality of life and developing life-changing therapies [4]. - The company focuses on scientific excellence and continuous improvement to enable faster and more accurate diagnoses, ultimately reducing the time and cost of therapy development [4].

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]

Core Viewpoint - Biomerica Inc. has appointed Scott Madel as Chief Commercial Officer to enhance commercialization and revenue growth for its inFoods IBS product, which aims to improve the quality of life for patients with chronic gastrointestinal conditions [1][5][6]. Company Overview - Biomerica Inc. is a global biomedical technology company focused on developing, patenting, manufacturing, and marketing advanced diagnostic and therapeutic products, particularly for gastrointestinal and inflammatory diseases [12]. Leadership Appointment - Scott Madel brings over 20 years of experience in healthcare and diagnostics, having previously served as President of Boston Heart Diagnostics, where he led a successful turnaround and revenue growth [2][3]. - His past roles include CEO positions at BioHealth Diagnostics and Genova Diagnostics Europe, where he contributed to significant revenue growth and strategic partnerships [3][4]. Product Focus: inFoods IBS - inFoods IBS is a diagnostic-guided therapy that identifies food triggers causing symptoms in patients with IBS, using a simple finger-stick blood sample [7]. - The product offers a non-pharmaceutical, precision-based approach to symptom relief, targeting dietary changes based on individual immune responses [7]. Clinical Study Results - A multicenter clinical study published in Gastroenterology showed that 59.6% of patients in the treatment group achieved significant abdominal pain reduction compared to 42.2% in the control group [9]. - Among IBS-C patients, 67.1% in the treatment group achieved the endpoint versus 35.8% in the control group, indicating strong efficacy [9]. - The study highlighted inFoods IBS as the only targeted therapy demonstrating efficacy specifically in IBS-M patients, a historically underserved subgroup [10]. Strategic Goals - In his new role, Scott Madel will focus on expanding strategic partnerships, developing a robust payer strategy, and enhancing brand recognition for inFoods IBS [5][6]. - The company aims to achieve third-party payer reimbursement and scale provider engagement both domestically and internationally [5].

The Transplant Solutions Company •J u n e 5 , 2 0 2 5 Click to edit Master text styles Click to edit Master title style Patrick G, Kidney Transplant Recipient Safe Harbor Statement These slides and the accompanying oral presentation contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical fact contained in this presentation, including s ...