ProMedix Inc is a medical device spinout company from Oregon Health & Sciences University. Our fingertip, circulatory dysfunction monitoring device, “PeriFRL” saves thousands of lives by enabling physicians (through tracking minute changes in Capillary Refill Time – “CRT”) to rapidly identify septic shock, and noninvasively monitor efficacy of therapeutic interventions once sepsis is diagnosed – all in real-time, and all at the patient bedside. The ProMedix PeriFRL commercialization glidepath includes connectivity and use of multivariable predictive algorithms. Current sepsis forecasting platforms lack physiologic input beyond simple vital signs and suffer from a high false-positive rate. Adding objective CRT measurement, a high-value patient-specific physiologic marker, to sepsis prediction algorithms will reduce the rate of false positive tests, making the risk prediction models more actionable than what is currently available. Including this patient-specific measurement can also address some of the pitfalls commonly associated with AI risk prediction model implementation. This set of customers is broad – from EHR companies (e.g., POC Advisor), to partnered data integration platforms (e.g., Validic). No one else has a serial-capable, stand-alone ability to monitor sepsis. There are several pathways into the marketplace. Optical detection of peripheral microcirculation facilitates early recognition of onset of sepsis; meeting calls from end-users for increased responsiveness and improve value-based care. Therefore, hospitals will be our initial focus for direct sales of our noninvasive PeriFRL monitor – with a primary emphasis on emergency room, intensive care, and med surg departments. Once ensconced, we will rapidly scale to partnering with either forecasting platform providers (as described above), or with targeted strategics (like Baxter and Medtronic; both of whom we are presently under NDA) to integrate our outputs into their existing patient monitoring telemetry portfolio (either via patient vitals, or in improved perfusion monitoring).
Prince Sterilization Services
Prince Sterilization Services is the leading contract sterilization service provider specializing in moist heat steam, low-temperature vaporized hydrogen peroxide, pre-filled syringes, dry heat sterilization and depyrogenation services. With decades of expertise and state-of-the-art facilities and equipment, Prince is positioned to support medical device and pharmaceutical customers’ packaging, washing, and sterilization needs from development to commercialization. Operating in over 50,000 square feet of cGMP space, we ensure FDA and ISO 13485 compliance while prioritizing sustainability. All of Prince’s Contract Sterilization solutions satisfy cGMP while being the eco-friendliest, nontoxic, and sustainable modalities available. Prince is also a supplier of Ready-to-Use (RTU) vials, stoppers, seals, bottles, and other pharmaceutical and pharmacy drug product components. All processing of materials, including inspection, washing, depyrogenation/sterilization, and final packaging, is performed in ISO certified clean rooms. Water for injection (WFI) that meets USP and EN285 standards is used for all critical processes, including vial washers, component washers, and steam sterilizers. Prince is a leading provider of terminal sterilization for a variety of healthcare products, including medical devices, single-use bottles, and tubing sets, stainless steel components, APIs, filled drug products in vials, syringes, and IV bags, and many other materials and products. Our technical staff is ready to provide case-by-case consultation support when needed. Explore our comprehensive sterilization services at www.princesterilization.com or connect with us directly at info@princesterilization.com. | Prince Sterilization Services (Prince) is a trusted partner to the medical device, pharmaceutical, and broader life sciences industries as a premier provider of contract sterilization modalities, including steam, low-temperature vaporized hydrogen peroxide (VH2O2), and dry heat sterilization services, and sterile, ready-to-use (RTU) custom components. A third-generation business built on quality, technical confidence, and care; Prince delivers comprehensive contract sterilization services, ready-to-use components (RTU), and cleanroom kitting and packaging solutions from our FDA-registered, CGMP-compliant, and ISO 13485-certified facilities. Prince’s New Jersey campus spans over 100,000 ft² of GMP manufacturing, warehousing, and administrative space, equipped with full-facility backup generators. Prince is an industry-leading provider of ready-to-use vials, stoppers, seals, and sterile components. Take a virtual tour of the NJ campus at https://princesterilization.com. Reach our technical experts at info@princesterilization.com.
Pharmtrace Klinische Entwicklung GmbH
pharmtrace is an independent CRO providing strategies and solutions for clinical trials. pharmtrace offers flexible services and a global reach for studies with imaging endpoints, radiopharmaceuticals, and radiological interventional procedures. pharmtrace’s experienced team and international medical specialists network ensure that your investment in medical imaging, radiopharmaceuticals and radiological interventions delivers meaningful data. With our GCP compliant image management platform (ERICA) we support you to generate robust data to convince authorities and decision makers, and to achieve your development target. pharmtrace’s customers include biotech and academia, as well as internationally engaged pharmaceutical companies and device manufacturers. | Full-service clinical trial management by a team that understands imaging and radiopharmaceuticals as deeply as clinical operations. pharmtrace is a private, independent contract research organisation for the pharmaceutical and medical device industry. We focus on clinical studies where diagnostic imaging and/or nuclear medicine approaches are a major component for efficacy or safety assessment — including RECIST-based oncology trials, therapeutic radiopharmaceutical programmes, and medical device investigations. Our clients are global pharmaceutical companies, biotech firms, and academic sponsors across North America, Europe, and Australasia. We have managed clinical trials across oncology, neurology, cardiology, and other therapeutic areas — from first-in-human exploratory studies through Phase 3 registration trials and Phase 4 post-marketing commitments. In each, imaging expertise was built in from the protocol stage, not retrofitted. Our experience includes studies that have supported marketing authorisation applications to FDA and EMA. We know what these submissions require and design our processes accordingly from the outset. pharmtrace’s Imaging Core Lab provides comprehensive support for all imaging aspects of clinical trials and medical device investigations. Whether your study applies RECIST 1.1 or iRECIST for tumour response in oncology, PERCIST for PET-based assessment, quantitative MRI endpoints in neurology, SPECT imaging in cardiology, or quantitative imaging for a medical device investigation — we standardise, collect, quality-control, and independently review images with the rigour that regulatory submissions require. Our proprietary ERICA platform, validated to GAMP5 Category 5, serves as the single environment for DICOM image storage, technical and medical QC, and blinded read sessions — with per-study configuration validation for every project. We support sponsors at any stage — from early imaging strategy and endpoint selection through regulatory meeting preparation and marketing authorisation support. Our advice is grounded in operational experience, not theory.
Mediclone Biotech Private Limited
Mediclone Biotech is a Biotech company specializing on Immuno biotechnology under the ambit of Medical Biotechnology. It was started in 1995 in Chennai as a maiden biotech venture by first-generation entrepreneurs. As of today, Mediclone has more than 1,00,000 Square feet of infrastructure comprising Therapeutics and Diagnostics manufacturing facility. Driven by a passion for innovation and excellence, Mediclone Biotech integrates the latest advancements in biotechnology with rigorous scientific research to deliver high-quality solutions that improve patient outcomes. The company’s R&D facilities are equipped with state-of-the-art technologies and staffed by highly skilled scientists and researchers, enabling the development of next-generation products that meet the highest standards of efficacy and safety. Mediclone Biotech continues to grow on its R&D foundation, it takes the necessary steps toward ensuring scalability and production consistency by transitioning into Good Manufacturing Practices (GMP). Mediclone biotech is committed to advancing in the fields of diagnostics, therapeutics, and life sciences. The company’s dedicated R&D team continuously works on discovering and creating novel molecules, cutting-edge diagnostic kits, and medical devices to address unmet medical needs across the globe. GMP compliance is central to the company’s mission, as it ensures that products are manufactured with the highest quality standards, reliability, and safety. By adhering to GMP regulations, Mediclone Biotech guarantees that its products meet international standards, ensuring their suitability for clinical and commercial use. Through continuous innovation, research, and GMP-compliant production, Mediclone Biotech strives to be a leading player in the biotech industry, committed to advancing healthcare and improving lives worldwide. Some of the Major Research and Development projects handled by Mediclone Biotech Pvt. Ltd. 1. An alternative technology to anti-snake venom serum using monoclonal Fab2 cocktail – Commercial Scale Manufacturing (Phase-II) in collaboration with Department of Biotechnology, New Delhi, India. 2. Development and Manufacture of Anti-Rabies Monoclonal antibody (MAb) cocktail as Post-exposure prophylaxis in collaboration with Department of Science and Technology (DST), New Delhi, India 3. Development of an Immunodiagnostic MAb for Rabies Virus Detection kit. (In-House) 4. Monoclonal therapeutics to prevent RhD antigen sensitization in hemolytic disease of the newborn (HDN). (In-House) 5. Role of MC1A Gene in the Pathogenesis of Mycobacterium Tuberculosis – Specific approach Using Monoclonal Antibodies in collaboration with Public Health England, U.K. 6. MOA signed with Beckton Dickson, USA – Monoclonal Antibody manufacturing for six different molecules of various Therapeutic Antigens.
J R Biomedical
J R Biomedical is a UK based, ISO13485 certified medical diagnostics company, who have developed a panel of proprietary antibodies, and a rapid point-of-care test to detect plasma soluble Toll-like receptor 2 (sTLR2), a biomarker known to be elevated in sepsis, and infective and non-infective inflammation. UK Patent Application GB2502531.3. The imiwn sTLR2 RAPID test gives results in 10 minutes and is UKCA certified and registered with MHRA. An independent study of sTLR2 versus CRP in critically ill patients showed that sTLR2 had better specificity and sensitivity for sepsis than C-reactive protein, the most commonly used marker in the ICU. Further, low sTLR2 levels had good ability to rule out sepsis within the first 12 h of ICU stay, when clinical parameters and traditional markers of infection are often equivocal. Global licensing and distribution opportunities for the sTLR2 antibody panel and rapid test are available.
Integrated Micro-Chromatography Systems, LLC
Integrated Micro-Chromatography Systems, Inc. (IMCS) is a privately-held biotech company that designs, manufactures, and distributes biological reagents from next- generation recombinant proteins to micro-chromatography consumables. The company’s product lines, IMCSzyme® ,IMCStips® and our most recent addition, IMCSglyco serve various clients, including clinical and forensic toxicology labs, academic research facilities, US federal government agencies, and life science companies in North America, Europe, and the Asia Pacific.
Immunology Consultants Laboratory, Inc.
ICL is a U.S.-based manufacturer of biochemical reagents and life science products, specializing in the production of antibodies and ELISA kits for both IVD and research applications. With over 45 years in the biotech industry, ICL has built a strong presence among the world’s leading research institutions, in vitro diagnostics (IVD) manufacturers, and biopharma companies. Backed by in-house research and development, ICL also offers custom solutions for research teams and IVD companies with needs that go beyond standard offerings. | With over 45 years of expertise, ICL is a U.S.-based manufacturer of high-quality antibodies and immunoassays serving the global life science market, including CDMOs, pharmaceutical companies, and IVD manufacturers. From our laboratory in Portland, Oregon, we produce reliable primary and secondary antibodies, ELISA kits, and host cell protein (HCP) detection assays in both human and animal models. Whether you’re developing a commercial diagnostic, optimizing a bioprocess, or conducting critical research, our reagents are designed to meet your performance standards. Explore our catalog or contact us to learn how our custom antibody and assay development services can support your next project.
Huna
Supercharging routine blood exams with AI, Huna turns massive data into accessible cancer care. By partnering with global leaders and leveraging one of the world’s largest oncology datasets, we deliver scalable solutions for early detection and risk stratification. Our platform supports the full cancer journey—from triage to diagnosis and beyond—transforming standard lab data into powerful clinical insights. Huna makes cutting-edge innovation usable by real-world healthcare systems tackling one of the world’s biggest health challenges.
HiComp
Established in 2014, HiComp Microtech stands as a premier original design manufacturer specializing in advanced microfluidics products and laboratory consumables. Our solutions boost precision, efficiency, and reliability from prototyping to mass production. Quality, performance and affordability are our priorities. | Established in 2014, HiComp Microtech is a leading original design manufacturer (ODM) specializing in advanced microfluidic products and laboratory consumables. Our ISO-certified and FDA-registered facilities span 100,000 sq. ft., including approximately 40,000 sq. ft. of high-standard cleanroom space. We provide precision, efficiency, and reliability from prototyping through volume production, serving renowned pharmaceutical and clinical diagnostic companies globally. With a proven track record, HiComp has successfully completed over 100 commercialized projects. Our services include: • Product Design • 3D Printing • CNC Micro Milling • MEMS Manufacturing • PDMS Manufacturing • Organoids/Organ on a Chip • Cleanroom Injection Molding • Surface Functionalization • Bonding & Sealing • Custom Microwell Plates • Assembly & Automation • Reagent Storage and Lyophilization
FIOCRUZ/Bio-Manguinhos
The Institute of Technology in Immunobiologicals (Bio-Manguinhos) is the technical-scientific unit of the Oswaldo Cruz Foundation (Fiocruz) that produces and develops immunobiologicals to meet the demands of public health. Its product line consists of vaccines, reagent kits for laboratory diagnosis and biopharmaceuticals. Founded in 1976, Bio-Manguinhos is a reference in the sector and occupies a prominent position in the market. | The Institute of Technology on Immunobiologicals (Bio-Manguinhos) is the unit of the Oswaldo Cruz Foundation (Fiocruz) responsible for research, innovation, technological development and production of vaccines, in vitro diagnostics (IVDs), biopharmaceuticals and advanced therapies primarily aimed at meeting the demands of Brazilian Public Health System (SUS), besides providing technological services. The Institute also contributes with the public health of several countries, mainly by the supply of the yellow fever vaccine, pre-qualified by WHO. With 49 years of existence, it has become the largest federal laboratory in Latin America and has consolidated itself as a strategic agent of public health policies in Brazil, having been selected by WHO/OPAS as Hub for mRNA COVID-19 Vaccine production to Latin America and Caribbean. To keep up with the trends and best practices in the pharmaceutical industry, the investment in the expansion and modernization of infrastructure is constant, being part of the innovation process of Bio-Manguinhos. With its own technological development projects and partnerships, in addition to technology transfer agreements with public and private institutions, the Institute provides a range of products for the Brazilian Public Health System (SUS), through the programs of the Ministry of Health. In the period from 2019 to 2024, there were approximately 800 million doses of vaccines delivered to the National Immunization Program; more than 66 million reagent kits for laboratory diagnosis; and 35 million bottles/syringes of biopharmaceuticals. Bio-Manguinhos products guarantee free access to high-tech immunobiologicals by the Brazilian population and allow the reduction of expenses by the Ministry of Health. This leading role in the field of public health is the result of the commitment of 2,400 employees who make the difference in the lives of millions of people every day.