FAQs

Frequently Asked Questions

Explore the answers to some of our more frequently asked questions.

Pepex proprietary biosensor technologies, referred to individually as Composite Conductive Monofilament (CCM®), 3 Electrode (3E™), and Lansing Sensor (LS®), and  collectively as Pepex Biosensor Technologies (PBT), are capable of identifying hundreds of unique biomarkerswhich indicate the presence, and in some cases the concentration level, of cancers, lactic acid, sepsis, Alzheimer’s, HIV, Ebola, hepatitis, Traumatic Brain Injury (TBI), tuberculosis, CV-19, and other life-altering conditions quickly, easily, and cost effectively in saliva, blood, and interstitial fluid.

Pepex and TheraSense, Inc., an affiliated company created to commercialize technology created by a joint team of researchers, were founded in 1995 as a joint venture effort by Dr. Heller of the University of Texas. During the ensuing 9 years, approximately $100MM was invested to sponsor biosensor technology development efforts, the result of which was the originalFreeStyle® Libre® branded blood glucose monitoring system. After a highly successful product launch, in 2004 TheraSense was acquired for over one billion dollars by Abbott Labs while Pepex retained usage rights to all IP developed to that point, as well as a core staff of researchers and developers.  Since 2004, Pepex raised significant additional funding that supported conducting over 35,000 documented experiments producing over 300 global patents that protect its proprietary manufacturing processes and biosensor designs.

• Accuracy – produces +98% sensitivity and specificity
• Timeliness – diagnostic results in seconds to minutes
• Cost Effectiveness – typically less than $10.00/unit
• Ease of Use – self-administered/disposable options
• Versatility – configurable for single use, continuous monitoring, catheter & in-line form factor applications

With adequate financial resources, Pepex plans to pursue commercialization efforts targeting those specific use cases which offer the greatest ROI opportunity based on key quantifiable criteria including short/long-term revenue potential, projected time to market, prospective customer level of interest, and probability of successful outcome. The projected lead time to deliver functional prototypes for specific use cases is approximately 4-6 months, assuming the associated biomarker or analyte is clearly defined. Moving forward, Pepex intends to be the sole source provider of PEEK fiber installed in a customer-specified form factor, and capable of assisting partners with requisite design for manufacturing (DFM), pilot production, full-rate manufacturing, and high-volume assembly, as required.

For investment opportunities in Pepex® Biomedical and its groundbreaking biosensor technology, interested parties can contact our investor relations team or visit our website for more information on available investment options.

A biological marker (biomarker) is a defined characteristic that is measured as an indicator of normal biological processes, pathogenic processes, or biological responses to an exposure or intervention, including therapeutic interventions.  Biomarkers have various applications, such as risk estimation, disease screening and detection, diagnosis, estimation of prognosis, prediction of benefit from therapy, and disease monitoring.

An analyte is a substance or molecule that is being analyzed or studied in a laboratory setting. It can refer to any type of molecule, including drugs, hormones, proteins, or other biological compounds. The term analyte is commonly used in the fields of chemistry, biochemistry, and clinical laboratory science to refer to the substance being measured or tested.  The analysis of an analyte can be performed using a variety of techniques, including spectrophotometry, chromatography, and mass spectrometry. The specific method used will depend on the type of analyte being studied and the desired information being sought.  The measurement of analytes is important in a variety of fields, including medical diagnostics, environmental monitoring, and quality control. In the medical field, for example, the measurement of analytes such as glucose, cholesterol, and electrolytes can provide important information about a patient’s health and assist in the diagnosis and treatment of various conditions.

Artificial intelligence, or AI, is technology that enables computers and machines to simulate human intelligence and problem-solving capabilities.  On its own or combined with other technologies (e.g., sensors, geolocation, robotics) AI can perform tasks that would otherwise require human intelligence or intervention.  As a field of computer science, artificial intelligence encompasses (and is often mentioned together with) machine learning and deep learning. These disciplines involve the development of AI algorithms, modeled after the decision-making processes of the human brain, that can ‘learn’ from available data and make increasingly more accurate classifications or predictions over time.

In recent years, an emerging class of manufacturing techniques has become available which offers significant cost, time and quality benefits across a broad spectrum of industries. These new techniques are collectively known as additive manufacturing. During additive manufacturing, material is deposited layer by layer to build up structures or features. This is in contrast to traditional subtractive manufacturing methods where masking and etching processes are used to remove material to get to the final form. Advantages of additive manufacturing processes include direct CAD-driven, art-to-part processing, which eliminates expensive hard-tooling, masks, and vertical/horizontal integration, which lead to fewer overall manufacturing steps.

Design for manufacturing (DFM) is a product design ideology that focuses on creating a better design at a lower cost by optimizing the selection of materials and manufacturing processes. Following these guidelines, the final product should be easier to manufacture, and the production should take less time when compared to the original design. DFM also incorporates the use of new ideas and techniques to bring about a positive change in product design to benefit all the involved parties (designer, manufacturer, and customer).. Design for manufacturing focuses on minimizing the complexities involved in manufacturing operations as well as reducing the overall part production cost. The principles involved in DFM are standardizing of materials and components, minimizing part counts, designing for efficient assembly, simplifying and reducing the number of manufacturing operations and creating modular assemblies, while the process involved in DFM includes raw material selection and review, secondary processes if any, dimensional and other requirements, and final packaging.

Aerosol Jet printing is a breakthrough manufacturing technology that is an emerging replacement for traditional thick-film processes like screen-print, photolithography and micro-dispensing, as well as being far more capable than inkjet. The aerosol jet printing process utilizes an aerodynamic focusing technology to produce electronic and physical structures with feature sizes as small as 5 microns and can also produce wide area conformal coatings. Aerosol jet printing supports a wide variety of materials, including nanoparticle inks and screen-printing pastes, conductive polymers, insulators, adhesives, and even biological matter.

A Nanoparticle is an ultrafine unit with dimensions measured in nanometers (nm; 1 nm = 10−9 meter). Nanoparticles exist in the natural world and are also created as a result of human activities. Because of their submicroscopic size, they have unique material characteristics, and manufactured nanoparticles may find practical applications in a variety of areas, including biomedicine, engineering, manufacturing, catalysis, and environmental remediation.

PEEK fiber (Polyetheretherketone) is a thermoplastic polymer available in various forms, including multifilament, monofilament, and spun yarns. It offers excellent mechanical properties that are maintained even under extreme conditions. PEEK also has unique properties like total biocompatibility, UV resistance, pure radiolucency, gamma-ray resistance, and low/no toxicity in all forms. These properties allow PEEK plastic to be implemented in many engineering applications, from automotive engine parts to medical implants, bearings, chemical equipment, and even radioactive applications.

A contract development and manufacturing organization, or CDMO, provides end-to-end, fully integrated product development and manufacturing solution to biotechnology and medical device companies. Specifically, a medical device CDMO offers its clients the ability to scale up faster, accelerate revenue and time to market, and deliver greater product value which provides acompetitive advantage for medtech companies through vertical integration of the product value chain. Furthermore, a CDMO serves as a real collaborative partner in the product developmentand manufacturing processes, including product optimization, as they work with customers on the journey from discovery to commercialization and beyond.

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